Query SELECT `session_id` FROM `user_session_data_storage` WHERE `session_id` = ? : 
Statement could not be executed (HY000 - 145 - Table './db05/user_session_data_storage' is marked as crashed and should be repaired)
Query INSERT INTO `user_session_data_storage` SET `last_activity` = NOW(), `session_id` = ? : 
Statement could not be executed (HY000 - 145 - Table './db05/user_session_data_storage' is marked as crashed and should be repaired)
Director Sterile Quality Assurance. Job in West Point, Pennsylvania, United States in Merck & Co., Inc.. Nelest.com
Home  |  Contact  |  About Us
|   Register  |  Sign In

Director Sterile Quality Assurance

col-narrow-left   

Job ID:

22212

Location:

West Point, PA 

Job function:

Legal Services
col-narrow-right   

Posted:

03.05.2016

Employment Type:

Full time

Industry:

Healthcare / Pharma
col-wide   

Title:

Director Sterile Quality Assurance

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 Director in Quality Assurance for Sterile Processing and Microbiology supports all Quality activities relating to the manufacture of sterile products and microbiology topics for non-sterile and bio-burden reduced products across the internal and external MMD Human Health network to ensure compliance with all applicable regulations and specifications.

Responsibilities:

  • Owns the Division Quality Management documents for non-sterile products, bioburden reduced product (e.g. biologics), and clean utilities. Responsibilities include
    • Authors and/or reviews divisional documents.
    • Compliance to regulatory requirements, evolving regulatory expectations, and internal and external trends.
    • Ensuring new documents are appropriately authored, tri-annual updates are completed on time,
    • Develops and delivers standard training and
    • Provides hands-on support to sites in achieving the standards
    • Partners with Regional Compliance Leaders and site QA leads to ensure consistency
    • Keep current with emerging internal and external trends to ensure divisional standards are kept up to date
  • Presents proposals for divisional requirements which have significant impact or carry a compliance risk to key divisional committees
  • Provides expert support to sites in preparation for, during, and in response to regulatory inspections.
  • Sterile Processing and Microbiology Quality Assurance representative for external regulatory surveillance
  • Provides Quality leadership and direction to sterile manufacturing sites within the internal and external network for implementation of QA initiatives and Quality POL, GDL, SOP and QB and the achievement of GMP compliance.
  • Ensures compliance issues identified by sites or through agency inspections are assessed for divisional impact and effectively resolved.
  • Sponsors, leads or participates in key initiatives related to development and deployment of divisional policy and guidance.
  • Active participant in industry organizations such as PDA, ISPE, or PhRMA.
~ Travel: Yes, 50 % of the Time Description Director Sterile Quality Assurance-REG001963 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 Director in Quality Assurance for Sterile Processing and Microbiology supports all Quality activities relating to the manufacture of sterile products and microbiology topics for non-sterile and bio-burden reduced products across the internal and external MMD Human Health network to ensure compliance with all applicable regulations and specifications.

Responsibilities:

  • Owns the Division Quality Management documents for non-sterile products, bioburden reduced product (e.g. biologics), and clean utilities. Responsibilities include
    • Authors and/or reviews divisional documents.
    • Compliance to regulatory requirements, evolving regulatory expectations, and internal and external trends.
    • Ensuring new documents are appropriately authored, tri-annual updates are completed on time,
    • Develops and delivers standard training and
    • Provides hands-on support to sites in achieving the standards
    • Partners with Regional Compliance Leaders and site QA leads to ensure consistency
    • Keep current with emerging internal and external trends to ensure divisional standards are kept up to date

Job Requirements:

Qualifications

Education:

- B.S., M.S. and/or Ph.D. preferably in Science or Engineering

Required:

- A minimum of 10 years of experience in the pharmaceutical, biopharmaceutical, vaccine, or medical device industry.

- Expert knowledge of EMEA, MHRA, and FDA regulations

- Experienced with USP, EP, and BP and ISP industry standards

- Expert knowledge of microbiology controls in Biologic (bioburden reduced), non-sterile, and/or sterile processes

- Highly experienced in regulatory inspection and responses.

- Highly experienced in listening to and gathering a range of perspectives and with ability to develop solutions and champion a position.

- Able to travel 50% of the time.

Preferred:

- Expert knowledge of international GMPs and Quality Management requirements of various regulatory agencies, e.g. TGA, HPB, ANVISA, COFEPRIS, ANMAT, KFDA, and PMDA.

- Direct experience working as part of a regulatory agency.

- Accountable for actions, drives results, and learns from mistakes.

- Demonstrates good judgment in collecting and synthesizing relevant data and information to make independent and timely decisions

- Communicates influences and escalates issues and decisions, as appropriate.

- Communicates effectively up and down, at all levels of the organization.

- Goes to the shop floor to see the problems and work directly with people on the shop floor.

- Technical understanding of biologics, vaccines and small molecule manufacturing processes.

- Ability to influence, facilitate groups with diverse perspectives, bring teams to consensus/alignment.

- Demonstrates tolerance for ambiguity.

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:

19486

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

Director Sterile Quality Assurance

col-narrow-left   

Job ID:

22212

Location:

West Point, PA 

Job function:

Legal Services
col-narrow-right   

Posted:

03.05.2016

Employment Type:

Full time

Industry:

Healthcare / Pharma
col-wide   

Title:

Director Sterile Quality Assurance

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 Director in Quality Assurance for Sterile Processing and Microbiology supports all Quality activities relating to the manufacture of sterile products and microbiology topics for non-sterile and bio-burden reduced products across the internal and external MMD Human Health network to ensure compliance with all applicable regulations and specifications.

Responsibilities:

  • Owns the Division Quality Management documents for non-sterile products, bioburden reduced product (e.g. biologics), and clean utilities. Responsibilities include
    • Authors and/or reviews divisional documents.
    • Compliance to regulatory requirements, evolving regulatory expectations, and internal and external trends.
    • Ensuring new documents are appropriately authored, tri-annual updates are completed on time,
    • Develops and delivers standard training and
    • Provides hands-on support to sites in achieving the standards
    • Partners with Regional Compliance Leaders and site QA leads to ensure consistency
    • Keep current with emerging internal and external trends to ensure divisional standards are kept up to date
  • Presents proposals for divisional requirements which have significant impact or carry a compliance risk to key divisional committees
  • Provides expert support to sites in preparation for, during, and in response to regulatory inspections.
  • Sterile Processing and Microbiology Quality Assurance representative for external regulatory surveillance
  • Provides Quality leadership and direction to sterile manufacturing sites within the internal and external network for implementation of QA initiatives and Quality POL, GDL, SOP and QB and the achievement of GMP compliance.
  • Ensures compliance issues identified by sites or through agency inspections are assessed for divisional impact and effectively resolved.
  • Sponsors, leads or participates in key initiatives related to development and deployment of divisional policy and guidance.
  • Active participant in industry organizations such as PDA, ISPE, or PhRMA.
~ Travel: Yes, 50 % of the Time Description Director Sterile Quality Assurance-REG001963 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 Director in Quality Assurance for Sterile Processing and Microbiology supports all Quality activities relating to the manufacture of sterile products and microbiology topics for non-sterile and bio-burden reduced products across the internal and external MMD Human Health network to ensure compliance with all applicable regulations and specifications.

Responsibilities:

  • Owns the Division Quality Management documents for non-sterile products, bioburden reduced product (e.g. biologics), and clean utilities. Responsibilities include
    • Authors and/or reviews divisional documents.
    • Compliance to regulatory requirements, evolving regulatory expectations, and internal and external trends.
    • Ensuring new documents are appropriately authored, tri-annual updates are completed on time,
    • Develops and delivers standard training and
    • Provides hands-on support to sites in achieving the standards
    • Partners with Regional Compliance Leaders and site QA leads to ensure consistency
    • Keep current with emerging internal and external trends to ensure divisional standards are kept up to date

Job Requirements:

Qualifications

Education:

- B.S., M.S. and/or Ph.D. preferably in Science or Engineering

Required:

- A minimum of 10 years of experience in the pharmaceutical, biopharmaceutical, vaccine, or medical device industry.

- Expert knowledge of EMEA, MHRA, and FDA regulations

- Experienced with USP, EP, and BP and ISP industry standards

- Expert knowledge of microbiology controls in Biologic (bioburden reduced), non-sterile, and/or sterile processes

- Highly experienced in regulatory inspection and responses.

- Highly experienced in listening to and gathering a range of perspectives and with ability to develop solutions and champion a position.

- Able to travel 50% of the time.

Preferred:

- Expert knowledge of international GMPs and Quality Management requirements of various regulatory agencies, e.g. TGA, HPB, ANVISA, COFEPRIS, ANMAT, KFDA, and PMDA.

- Direct experience working as part of a regulatory agency.

- Accountable for actions, drives results, and learns from mistakes.

- Demonstrates good judgment in collecting and synthesizing relevant data and information to make independent and timely decisions

- Communicates influences and escalates issues and decisions, as appropriate.

- Communicates effectively up and down, at all levels of the organization.

- Goes to the shop floor to see the problems and work directly with people on the shop floor.

- Technical understanding of biologics, vaccines and small molecule manufacturing processes.

- Ability to influence, facilitate groups with diverse perspectives, bring teams to consensus/alignment.

- Demonstrates tolerance for ambiguity.

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:

19486
Copyright © 2016 NELEST.COM All rights reserved