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Executive Director MRL QA Vendor, IT & Process Head. Job in Rahway, New Jersey, United States in Merck & Co., Inc.. Nelest.com
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Executive Director MRL QA Vendor, IT & Process Head

col-narrow-left   

Job ID:

22142

Location:

Rahway, NJ 

Job function:

Business Development, Public Relations
col-narrow-right   

Posted:

03.05.2016

Employment Type:

Full time

Industry:

Healthcare / Pharma
col-wide   

Title:

Executive Director MRL QA Vendor, IT & Process Head

Job Description:

Description Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. Today, we are building a new kind of healthcare company - one that is ready to help create a healthier future for all of us. Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you. To this end, we strive to create an environment of mutual respect, encouragement and teamwork. As part of our global team, you'll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career. The purpose of the MRL (Merck Research Labs) Quality Assurance Vendor, IT and Process Head is to be responsible for ensuring implementation and management of the customized risk strategy, utilizing audit and external environment (e.g. inspections, health authority guidance) intelligence to formulate and implement quality assurance risk mitigation strategies (e.g. QbD), to uphold the rights and welfare of patients the quality and integrity of data generated at the vendors Merck employs and also with of clinical study conduct processes. The QA Vendor, IT and Process Head position will develop strong collaborative partnerships with Global Clinical Trial Operations (GCTO) with a thorough understanding of potential areas of exposure and emerging/changing uses of vendors that contribute to the prioritization assessment for vendor audits. Additionally, the Head will work with GCTO to evaluate the quality assessments to evaluate the processes that support clinical trial execution.
The QA Vendor, IT and Process Head position will manage the QA activities including the audit program and will be responsible to perform risk assessments to identify audit targets, create audit plan proposals, conduct audits, develop and maintain audit tools, as well as, perform technical reviews of audit reports when required. In addition, the position will track deliverables, monitor trends and provide input with regard to vendor performance as well as process performance.

The QA Vendor, IT and Process Head, either directly or through matrix relationships, will ensure appropriate alignment of QA resources as well as ensuring the best and most efficient use of MRL QA and stakeholder resources. This is accomplished through close partnership within MRL QA and with our business stakeholders.

This position will require travel to Merck locations and travel to oversee quality assurance activities.






Organizational Relationships:

  • Reports to Head, MRL QA
  • Member, MRL QA Leadership Team
  • Partners with Heads of MRL QA GLP, Animal Welfare, Therapeutic Area Heads. Assure consistent professional and appropriate MRL QA support across MRL in terms of quality assurance oversight
  • Works with all relevant local global MRL R + D staff (GCTO, GCO, Translational Medicine, GRACS) and other contacts including GHH Medical Affairs, Compliance, Regulatory Law
  • Works with external contacts including Regulatory authorities as it applies to inspection and other activities (FDA, EMA, MHRA, etc.), professional scientific groups and consultants
  • Works with CAPA owners to make certain CAPA is appropriate, effective and sustainable

Primary Duties/Accountabilities:

The MRL QA Vendor, IT & Process Audit Head represents MRL QA on assigned or as delegate for MRL QA Head applicable committees. The remit is to appropriately represent the current and / or potential quality risks to ensure substantial quality and high quality data from our trials. Additionally the role is to effectively ensure substantial quality in new programs and to work with MRL QA Head and Key stake holders in Clinical and Clinical Operations to develop strategies to promote successful health authority inspections and submission approval outcomes.


The MRL QA BP Head will manage, either directly or through matrix relationships, all the MRL QA staff within his/her respective group. In this role they will ensure appropriate alignment of roles, responsibilities and deliverables including audits and quality assurance activities for projects/products and to assess adequacy of GxP controls in place. The MRL QA Vendor, IT & Process Audit Head works to assure quality standards are consistently applied across MRL while allowing for flexible strategies to achieve goals.

The MRL QA Vendor, IT & Process Audit Head is accountable for ensuring that any stakeholder (MRL QA and Business Partner) support area specific considerations for the respective projects and products are reflected in the relevant global QA strategy. This is accomplished through close partnership with appropriate MRL LT, Clinical, Translational medicine, CORE and Clinical Operations and other specific area leaders to contribute to the value and ensure date integrity of the portfolio.

The MRL QA Vendor, IT & Process Audit Head effectively engages teams and has proven ability to represent MRL QA aligned strategies and processes.

The MRL QA Vendor, IT & Process Audit Head demonstrates capacity to advise teams and individuals, including mentoring and coaching colleagues, as needed.

The MRL QA Vendor, IT & Process Audit Head will be responsible for staff and talent management development, including performance management. The MRL QA Vendor, IT & Process Audit Head will conduct timely and efficient internal communication of resource and data quality matters.

As a part of the MRL QA Leadership Team, the MRL QA Vendor, IT & Process Audit Head:












  • Will work with MRL QA LT to redefine QA at Merck and will collaborate on the redesign of Quality Assurance activities including examples: the integration of end to end quality principles and the redesign of execution of audit in MRL
  • Has joint management accountability for the MRL QA budget
  • Represents MRL QA as single point of contact for Vendor, IT and Process related initiatives
  • Responsible for understanding unique needs of stakeholder functions including MRL QA, and their associated strategies for the deliverables.
  • Leads MRL QA in the development of risk mitigation strategies, partners with Stakeholder Functions and Operations leaders and cross-functional lines for continuous management of quality issues across projects and products.
  • Engages in appropriate activities to support product submissions and influence the inspection environment.
  • Convenes MRL QA team assuring the establishment and maintenance of a collaborative performance oriented culture that embodies Merck Values and Leader Behaviors.
  • Responsible for effectively forecasting all audit needs, collaborating with the MRL QA LT to identify and allocate MRL QA talent.
  • Responsible for soliciting feedback on the performance of MRL QA colleagues from the relevant MRL parties in GCO, GCTO, Translational Medicine, GRACS, etc., and providing this as input to the formal colleague evaluation processes.
  • Will deliver critical expertise to the MRL QA LT, organization, customers and stakeholders via quality audit processes, systems, and responsibilities.
  • Maintains a current knowledge of industry quality trends is needed along with capacity to continue to build quality knowledge internally and externally.
  • As a member of the MRL QA LT, champions the QA mission and sets MRL QA policies and long- term strategies.
  • Peer to, and works closely with, MRL QA LT and is accountable for the MRL QA LT activities and deliverables within agreed timeframes.
  • Monitors and maintains industry wide expertise knowledge and trend relevant to the responsibility.
  • May assume responsibility for other activities/functions within MRL QA as required.
  • Collaborates on the development and implementation of robust strategic sourcing solutions for the MRL QA global organization in partnership with the MRL QA Leadership Team
Travel: Yes, 25 % of the Time Description Executive Director MRL QA Vendor, IT & Process Head-COM000372 Description Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. Today, we are building a new kind of healthcare company - one that is ready to help create a healthier future for all of us. Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you. To this end, we strive to create an environment of mutual respect, encouragement and teamwork. As part of our global team, you'll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career. The purpose of the MRL (Merck Research Labs) Quality Assurance Vendor, IT and Process Head is to be responsible for ensuring implementation and management of the customized risk strategy, utilizing audit and external environment (e.g. inspections, health authority guidance) intelligence to formulate and implement quality assurance risk mitigation strategies (e.g. QbD), to uphold the rights and welfare of patients the quality and integrity of data generated at the vendors Merck employs and also with of clinical study conduct processes. The QA Vendor, IT and Process Head position will develop strong collaborative partnerships with Global Clinical Trial Operations (GCTO) with a thorough understanding of potential areas of exposure and emerging/changing uses of vendors that contribute to the prioritization assessment for vendor audits. Additionally, the Head will work with GCTO to evaluate the quality assessments to evaluate the processes that support clinical trial execution.
The QA Vendor, IT and Process Head position will manage the QA activities including the audit program and will be responsible to perform risk assessments to identify audit targets, create audit plan proposals, conduct audits, develop and maintain audit tools, as well as, perform technical reviews of audit reports when required. In addition, the position will track deliverables, monitor trends and provide input with regard to vendor performance as well as process performance.

The QA Vendor, IT and Process Head, either directly or through matrix relationships, will ensure appropriate alignment of QA resources as well as ensuring the best and most efficient use of MRL QA and stakeholder resources. This is accomplished through close partnership within MRL QA and with our business stakeholders.

This position will require travel to Merck locations and travel to oversee quality assurance activities.

Organizational Relationships:

  • Reports to Head, MRL QA
  • Member, MRL QA Leadership Team
  • Partners with Heads of MRL QA GLP, Animal Welfare, Therapeutic Area Heads. Assure consistent professional and appropriate MRL QA support across MRL in terms of quality assurance oversight
  • Works with all relevant local global MRL R + D staff (GCTO, GCO, Translational Medicine, GRACS) and other contacts including GHH Medical Affairs, Compliance, Regulatory Law
  • Works with external contacts including Regulatory authorities as it applies to inspection and other activities (FDA, EMA, MHRA, etc.), professional scientific groups and consultants
  • Works with CAPA owners to make certain CAPA is appropriate, effective and sustainable

Job Requirements:

Qualifications Education Requirement:
  • Bachelor's degree
  • Advanced academic qualification/degree is preferred, equivalent relevant professional experience will be considered.

Required:

  • 15+ years clinical development oversight experience or relevant experience in clinical quality management, biomedical science, clinical development, IT, outsourcing regulatory compliance oversight or regulatory strategy, equivalent experience
  • 5 + years' experience in working with and directly communicating with senior leaders with proven accountability, and demonstrated excellent interpersonal, communication, negotiation, influencing, and problem-solving capabilities
  • Demonstrated teaching and coaching capabilities and experience as a manager of people
  • Proven ability to function autonomously at a senior level in a matrix model and in a team environment
  • Proven business management capability
  • Proven ability to think creatively and to develop and execute strategic plans
  • Travel Required: up to 30%

Preferred:

  • Clinical or academic experience an asset



Our employees are the key to our company's success. We demonstrate our commitment to our employees by offering a competitive and valuable rewards program. Our Company's benefits are designed to support the wide range of goals, needs and lifestyles of our employees, and many of the people that matter the most in their lives. If you need an accommodation for the application process please email us at staffingaadar@merck.com.

Search Firm Representatives Please Read Carefully: Merck & Co., Inc. is not accepting unsolicited assistance from search firms for this employment opportunity. Please, no phone calls or emails. All resumes submitted by search firms to any employee at Merck via email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of Merck. No fee will be paid in the event the candidate is hired by Merck as a result of the referral or through other means. Visa sponsorship is not available for this position. For more information about personal rights under Equal Employment Opportunity, visit: EEOC Poster EEOC GINA Supplement? Merck is an equal opportunity employer, Minority/Female/Disability/Veteran - proudly embracing diversity in all of its manifestations.

Zip Code:

7065

Company Info
Merck & Co., Inc.

Kenilworth, NJ, United States

Phone:
Web Site: merck.com

Company Profile

Company Info


Merck & Co., Inc.
Kenilworth, NJ, United States
Phone:
Web Site: merck.com

Executive Director MRL QA Vendor, IT & Process Head

col-narrow-left   

Job ID:

22142

Location:

Rahway, NJ 

Job function:

Business Development, Public Relations
col-narrow-right   

Posted:

03.05.2016

Employment Type:

Full time

Industry:

Healthcare / Pharma
col-wide   

Title:

Executive Director MRL QA Vendor, IT & Process Head

Job Description:

Description Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. Today, we are building a new kind of healthcare company - one that is ready to help create a healthier future for all of us. Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you. To this end, we strive to create an environment of mutual respect, encouragement and teamwork. As part of our global team, you'll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career. The purpose of the MRL (Merck Research Labs) Quality Assurance Vendor, IT and Process Head is to be responsible for ensuring implementation and management of the customized risk strategy, utilizing audit and external environment (e.g. inspections, health authority guidance) intelligence to formulate and implement quality assurance risk mitigation strategies (e.g. QbD), to uphold the rights and welfare of patients the quality and integrity of data generated at the vendors Merck employs and also with of clinical study conduct processes. The QA Vendor, IT and Process Head position will develop strong collaborative partnerships with Global Clinical Trial Operations (GCTO) with a thorough understanding of potential areas of exposure and emerging/changing uses of vendors that contribute to the prioritization assessment for vendor audits. Additionally, the Head will work with GCTO to evaluate the quality assessments to evaluate the processes that support clinical trial execution.
The QA Vendor, IT and Process Head position will manage the QA activities including the audit program and will be responsible to perform risk assessments to identify audit targets, create audit plan proposals, conduct audits, develop and maintain audit tools, as well as, perform technical reviews of audit reports when required. In addition, the position will track deliverables, monitor trends and provide input with regard to vendor performance as well as process performance.

The QA Vendor, IT and Process Head, either directly or through matrix relationships, will ensure appropriate alignment of QA resources as well as ensuring the best and most efficient use of MRL QA and stakeholder resources. This is accomplished through close partnership within MRL QA and with our business stakeholders.

This position will require travel to Merck locations and travel to oversee quality assurance activities.






Organizational Relationships:

  • Reports to Head, MRL QA
  • Member, MRL QA Leadership Team
  • Partners with Heads of MRL QA GLP, Animal Welfare, Therapeutic Area Heads. Assure consistent professional and appropriate MRL QA support across MRL in terms of quality assurance oversight
  • Works with all relevant local global MRL R + D staff (GCTO, GCO, Translational Medicine, GRACS) and other contacts including GHH Medical Affairs, Compliance, Regulatory Law
  • Works with external contacts including Regulatory authorities as it applies to inspection and other activities (FDA, EMA, MHRA, etc.), professional scientific groups and consultants
  • Works with CAPA owners to make certain CAPA is appropriate, effective and sustainable

Primary Duties/Accountabilities:

The MRL QA Vendor, IT & Process Audit Head represents MRL QA on assigned or as delegate for MRL QA Head applicable committees. The remit is to appropriately represent the current and / or potential quality risks to ensure substantial quality and high quality data from our trials. Additionally the role is to effectively ensure substantial quality in new programs and to work with MRL QA Head and Key stake holders in Clinical and Clinical Operations to develop strategies to promote successful health authority inspections and submission approval outcomes.


The MRL QA BP Head will manage, either directly or through matrix relationships, all the MRL QA staff within his/her respective group. In this role they will ensure appropriate alignment of roles, responsibilities and deliverables including audits and quality assurance activities for projects/products and to assess adequacy of GxP controls in place. The MRL QA Vendor, IT & Process Audit Head works to assure quality standards are consistently applied across MRL while allowing for flexible strategies to achieve goals.

The MRL QA Vendor, IT & Process Audit Head is accountable for ensuring that any stakeholder (MRL QA and Business Partner) support area specific considerations for the respective projects and products are reflected in the relevant global QA strategy. This is accomplished through close partnership with appropriate MRL LT, Clinical, Translational medicine, CORE and Clinical Operations and other specific area leaders to contribute to the value and ensure date integrity of the portfolio.

The MRL QA Vendor, IT & Process Audit Head effectively engages teams and has proven ability to represent MRL QA aligned strategies and processes.

The MRL QA Vendor, IT & Process Audit Head demonstrates capacity to advise teams and individuals, including mentoring and coaching colleagues, as needed.

The MRL QA Vendor, IT & Process Audit Head will be responsible for staff and talent management development, including performance management. The MRL QA Vendor, IT & Process Audit Head will conduct timely and efficient internal communication of resource and data quality matters.

As a part of the MRL QA Leadership Team, the MRL QA Vendor, IT & Process Audit Head:












  • Will work with MRL QA LT to redefine QA at Merck and will collaborate on the redesign of Quality Assurance activities including examples: the integration of end to end quality principles and the redesign of execution of audit in MRL
  • Has joint management accountability for the MRL QA budget
  • Represents MRL QA as single point of contact for Vendor, IT and Process related initiatives
  • Responsible for understanding unique needs of stakeholder functions including MRL QA, and their associated strategies for the deliverables.
  • Leads MRL QA in the development of risk mitigation strategies, partners with Stakeholder Functions and Operations leaders and cross-functional lines for continuous management of quality issues across projects and products.
  • Engages in appropriate activities to support product submissions and influence the inspection environment.
  • Convenes MRL QA team assuring the establishment and maintenance of a collaborative performance oriented culture that embodies Merck Values and Leader Behaviors.
  • Responsible for effectively forecasting all audit needs, collaborating with the MRL QA LT to identify and allocate MRL QA talent.
  • Responsible for soliciting feedback on the performance of MRL QA colleagues from the relevant MRL parties in GCO, GCTO, Translational Medicine, GRACS, etc., and providing this as input to the formal colleague evaluation processes.
  • Will deliver critical expertise to the MRL QA LT, organization, customers and stakeholders via quality audit processes, systems, and responsibilities.
  • Maintains a current knowledge of industry quality trends is needed along with capacity to continue to build quality knowledge internally and externally.
  • As a member of the MRL QA LT, champions the QA mission and sets MRL QA policies and long- term strategies.
  • Peer to, and works closely with, MRL QA LT and is accountable for the MRL QA LT activities and deliverables within agreed timeframes.
  • Monitors and maintains industry wide expertise knowledge and trend relevant to the responsibility.
  • May assume responsibility for other activities/functions within MRL QA as required.
  • Collaborates on the development and implementation of robust strategic sourcing solutions for the MRL QA global organization in partnership with the MRL QA Leadership Team
Travel: Yes, 25 % of the Time Description Executive Director MRL QA Vendor, IT & Process Head-COM000372 Description Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. Today, we are building a new kind of healthcare company - one that is ready to help create a healthier future for all of us. Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you. To this end, we strive to create an environment of mutual respect, encouragement and teamwork. As part of our global team, you'll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career. The purpose of the MRL (Merck Research Labs) Quality Assurance Vendor, IT and Process Head is to be responsible for ensuring implementation and management of the customized risk strategy, utilizing audit and external environment (e.g. inspections, health authority guidance) intelligence to formulate and implement quality assurance risk mitigation strategies (e.g. QbD), to uphold the rights and welfare of patients the quality and integrity of data generated at the vendors Merck employs and also with of clinical study conduct processes. The QA Vendor, IT and Process Head position will develop strong collaborative partnerships with Global Clinical Trial Operations (GCTO) with a thorough understanding of potential areas of exposure and emerging/changing uses of vendors that contribute to the prioritization assessment for vendor audits. Additionally, the Head will work with GCTO to evaluate the quality assessments to evaluate the processes that support clinical trial execution.
The QA Vendor, IT and Process Head position will manage the QA activities including the audit program and will be responsible to perform risk assessments to identify audit targets, create audit plan proposals, conduct audits, develop and maintain audit tools, as well as, perform technical reviews of audit reports when required. In addition, the position will track deliverables, monitor trends and provide input with regard to vendor performance as well as process performance.

The QA Vendor, IT and Process Head, either directly or through matrix relationships, will ensure appropriate alignment of QA resources as well as ensuring the best and most efficient use of MRL QA and stakeholder resources. This is accomplished through close partnership within MRL QA and with our business stakeholders.

This position will require travel to Merck locations and travel to oversee quality assurance activities.

Organizational Relationships:

  • Reports to Head, MRL QA
  • Member, MRL QA Leadership Team
  • Partners with Heads of MRL QA GLP, Animal Welfare, Therapeutic Area Heads. Assure consistent professional and appropriate MRL QA support across MRL in terms of quality assurance oversight
  • Works with all relevant local global MRL R + D staff (GCTO, GCO, Translational Medicine, GRACS) and other contacts including GHH Medical Affairs, Compliance, Regulatory Law
  • Works with external contacts including Regulatory authorities as it applies to inspection and other activities (FDA, EMA, MHRA, etc.), professional scientific groups and consultants
  • Works with CAPA owners to make certain CAPA is appropriate, effective and sustainable

Job Requirements:

Qualifications Education Requirement:
  • Bachelor's degree
  • Advanced academic qualification/degree is preferred, equivalent relevant professional experience will be considered.

Required:

  • 15+ years clinical development oversight experience or relevant experience in clinical quality management, biomedical science, clinical development, IT, outsourcing regulatory compliance oversight or regulatory strategy, equivalent experience
  • 5 + years' experience in working with and directly communicating with senior leaders with proven accountability, and demonstrated excellent interpersonal, communication, negotiation, influencing, and problem-solving capabilities
  • Demonstrated teaching and coaching capabilities and experience as a manager of people
  • Proven ability to function autonomously at a senior level in a matrix model and in a team environment
  • Proven business management capability
  • Proven ability to think creatively and to develop and execute strategic plans
  • Travel Required: up to 30%

Preferred:

  • Clinical or academic experience an asset



Our employees are the key to our company's success. We demonstrate our commitment to our employees by offering a competitive and valuable rewards program. Our Company's benefits are designed to support the wide range of goals, needs and lifestyles of our employees, and many of the people that matter the most in their lives. If you need an accommodation for the application process please email us at staffingaadar@merck.com.

Search Firm Representatives Please Read Carefully: Merck & Co., Inc. is not accepting unsolicited assistance from search firms for this employment opportunity. Please, no phone calls or emails. All resumes submitted by search firms to any employee at Merck via email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of Merck. No fee will be paid in the event the candidate is hired by Merck as a result of the referral or through other means. Visa sponsorship is not available for this position. For more information about personal rights under Equal Employment Opportunity, visit: EEOC Poster EEOC GINA Supplement? Merck is an equal opportunity employer, Minority/Female/Disability/Veteran - proudly embracing diversity in all of its manifestations.

Zip Code:

7065
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