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Associate Director, Vendor Quality Management, New Product Development QA Job. Job in Berkeley Heights, New Jersey, United States in Celgene Corporation. Nelest.com
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Associate Director, Vendor Quality Management, New Product Development QA Job

col-narrow-left   

Job ID:

23219

Location:

Berkeley Heights, NJ 

Job function:

Product Development
col-narrow-right   

Posted:

03.11.2016

Employment Type:

Full time

Industry:

Healthcare / Pharma
col-wide   

Title:

Associate Director, Vendor Quality Management, New Product Development QA Job

Job Description:

Celgene is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover and develop therapies that will change the course of human health. We value our passion for patients, quest for innovation, spirit of independence and love of challenge. With a presence in more than 70 countries - and growing we look for talented people to grow our business, advance our science and contribute to our unique culture.

Responsibilities include, but are not limited to, the following:
Manage Celgene Development Quality Operations Function: Directly supervise QA Operations analysts and specialists and other individuals responsible for the services provided by Quality Operations as required. Oversight of the API batch record review, change control, qualification and validation activates, technology transfer, complaint investigations as they relate to the assigned API contract Manufacturing or testing organization as the Vendor Quality Manager (VQM). Responsible for the release of product to the market. Responsible for developing and maintaining relationships with the Quality functions of Contract Service Providers (CSP). Responsible for leading the Quality Agreement negotiations, resolution of any discrepancies, and timely approval the Quality Agreement contracts. Notifies senior management of any major compliance issues at CSPs and collaborates with Technical Operations (API) representatives to meet the supply needs of the patients. Provides reports to senior management as requested. Tracks and reports on status of the Quality and Performance metrics indicators.

Vendor Contacts: Provides strategic direction to contract manufacturing and testing service providers regarding quality assurance issues. Provides constructive feedback and ensures vendors adhere to the Celgene quality standard. Responsible to ensure that vendor deviations are resolved in a timely manner and comply with the Celgene policies. Responsible to oversee that the change control actions by the CSP are performed appropriately in a timely manner. Collaborates with the compliance department in vendor selection, annual audit and overall vendor management program.

*LI-KM1

Job Requirements:


Prerequisties:
BS in a relevant scientific or pharmaceutical discipline. Advanced degree preferred. Ten plus years experience in a Pharmaceutical Quality Assurance functions. Knowledge of cGMP and applied quality systems. Emphasis on providing QA oversight for API batch record review, product disposition/release, change control, SOP authoring/review/approval, contractor management, qualification and validation documentation review/approval, technology transfer, complaint handling and management notification. Experience with contract development laboratories, contract manufacturing organizations and failure investigations. Skills/Knowledge Required:
- BS in a relevant scientific or pharmaceutical discipline. Advanced degree is preferred.
- 10 plus years of experience within QA functions in pharmaceutical industry with emphasis on API operations
- Thorough knowledge of cGMP in the pharmaceutical industry
- Experience with non-sterile manufacturing required, experience with sterile manufacturing is desired
- Knowledge and application experience with API batch record review, product disposition/release, change control, SOP review, contractor management, qualification and validation review, technology transfer and complaint handling.
- Good computer skills and working knowledge of common business software
- Excellent organizational skills
- Excellent problem-solving, verbal and written communication skills
- Must have strong interpersonal and communication skills, be a team player
- Must be an individual with proven initiative and demonstrated accountability
Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.

Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.

Travel: Yes, 15 % of the Time

Zip Code:

07922

Company Info
Celgene Corporation
86 Morris Avenue
Summit, NJ, United States

Phone: +1-908-673-9000, +41 32 729 85 00, 1-908-673-9800, 1-908-673-9800
Web Site: www.celgene.com

Company Profile

Company Info


Celgene Corporation
86 Morris Avenue
Summit, NJ, United States
Phone: +1-908-673-9000, +41 32 729 85 00, 1-908-673-9800, 1-908-673-9800
Web Site: www.celgene.com

Associate Director, Vendor Quality Management, New Product Development QA Job

col-narrow-left   

Job ID:

23219

Location:

Berkeley Heights, NJ 

Job function:

Product Development
col-narrow-right   

Posted:

03.11.2016

Employment Type:

Full time

Industry:

Healthcare / Pharma
col-wide   

Title:

Associate Director, Vendor Quality Management, New Product Development QA Job

Job Description:

Celgene is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover and develop therapies that will change the course of human health. We value our passion for patients, quest for innovation, spirit of independence and love of challenge. With a presence in more than 70 countries - and growing we look for talented people to grow our business, advance our science and contribute to our unique culture.

Responsibilities include, but are not limited to, the following:
Manage Celgene Development Quality Operations Function: Directly supervise QA Operations analysts and specialists and other individuals responsible for the services provided by Quality Operations as required. Oversight of the API batch record review, change control, qualification and validation activates, technology transfer, complaint investigations as they relate to the assigned API contract Manufacturing or testing organization as the Vendor Quality Manager (VQM). Responsible for the release of product to the market. Responsible for developing and maintaining relationships with the Quality functions of Contract Service Providers (CSP). Responsible for leading the Quality Agreement negotiations, resolution of any discrepancies, and timely approval the Quality Agreement contracts. Notifies senior management of any major compliance issues at CSPs and collaborates with Technical Operations (API) representatives to meet the supply needs of the patients. Provides reports to senior management as requested. Tracks and reports on status of the Quality and Performance metrics indicators.

Vendor Contacts: Provides strategic direction to contract manufacturing and testing service providers regarding quality assurance issues. Provides constructive feedback and ensures vendors adhere to the Celgene quality standard. Responsible to ensure that vendor deviations are resolved in a timely manner and comply with the Celgene policies. Responsible to oversee that the change control actions by the CSP are performed appropriately in a timely manner. Collaborates with the compliance department in vendor selection, annual audit and overall vendor management program.

*LI-KM1

Job Requirements:


Prerequisties:
BS in a relevant scientific or pharmaceutical discipline. Advanced degree preferred. Ten plus years experience in a Pharmaceutical Quality Assurance functions. Knowledge of cGMP and applied quality systems. Emphasis on providing QA oversight for API batch record review, product disposition/release, change control, SOP authoring/review/approval, contractor management, qualification and validation documentation review/approval, technology transfer, complaint handling and management notification. Experience with contract development laboratories, contract manufacturing organizations and failure investigations. Skills/Knowledge Required:
- BS in a relevant scientific or pharmaceutical discipline. Advanced degree is preferred.
- 10 plus years of experience within QA functions in pharmaceutical industry with emphasis on API operations
- Thorough knowledge of cGMP in the pharmaceutical industry
- Experience with non-sterile manufacturing required, experience with sterile manufacturing is desired
- Knowledge and application experience with API batch record review, product disposition/release, change control, SOP review, contractor management, qualification and validation review, technology transfer and complaint handling.
- Good computer skills and working knowledge of common business software
- Excellent organizational skills
- Excellent problem-solving, verbal and written communication skills
- Must have strong interpersonal and communication skills, be a team player
- Must be an individual with proven initiative and demonstrated accountability
Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.

Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.

Travel: Yes, 15 % of the Time

Zip Code:

07922
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