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Dir. PPU Quality Compliance
| Details |
Country: USA
Location: Andover MA
Total applied: 40
Location: US-MA-Andover Company:Wyeth Job Description:
Manage and guide certification activities for third party contractors for production of drug substance and drug product. Key role is developing and approval of supply and quality agreements. Negotiate and troubleshoot issues with contractors to ensure goals and objectives are met. Partner with Quality Unit functions and PPUs in working with third party contractors to improve quality systems while ensuring cGMP compliance. Experience in auditing, vendor qualification, contract manufacturing and agency inspections.
Develop and approve supply contracts, quality / technical agreements with third party, contract test labs, raw material suppliers and secondary contractors. Negotiate and troubleshoot issues with contractors to ensure company goals and objectives are met. Manage the tracking of all quality agreements with the Quality Unit.
Partner with other Quality Unit functions, Manufacturing, Validation, Global Strategic Sourcing and other Wyeth organizations in working with third party contractors on compliance issues with our agreements. Participate as a resource on project teams with third party contractors to evaluate and improve upon quality systems while ensuring cGMP compliance.
Accountable for managing and guidance of activities for third party contractors for product of drug substance and drug product. Work with Manufacturing, Validation, other Quality functions and third party contractors to direct, develop and complete certification activities.
Act as primary contact as Andover Quality Compliance Representative initiatives with regards to SCI Conformance Standards, Quality Agreements, Third Party Contractors, Cold Chain and Certification activities.
Reviews manufacturing and quality documentation to ensure compliance with cGMP standards. Develops and revises standard operating procedures as required.
Ensure third party contractors are held to same standards of quality compliance as the Wyeth organization.
Provide leadership role for Quality Unit operations as it relates to management of change control, training, deviations, performance metrics, trending, corrective and preventative action plans with third party contractors.
Requirements:
A Minimum of a Bachelor's Degree (B.S./B.A.) in a scientific discipline. At least 8-15 years experience in a regulated biopharmaceutical environment in drug substance and drug product environment.
Experience in auditing, vendor qualification, contract manufacturing and regulatory agency inspections. Travel (approximately 10-2
Wyeth offers competitive compensation and benefits programs including stock
options, child-care subsidies, flex-time, business casual attire,
educational assistance and professional development programs. Please
forward your resume with salary requirements and job reference code to the
address below.
For more information, visit our website at http://www.wyeth.com
Wyeth is an Equal Opportunity Employer, M/F/D/V.
Search Firm Representatives:
Please Read Carefully.
Wyeth is not seeking assistance or accepting unsolicited resumes from search firms for this employment opportunity. Regardless of past practice, all resumes submitted by search firms to any employee at Wyeth via-email, the Internet or directly to hiring managers at Wyeth in any form without a valid written search agreement in place for that position will be deemed the sole property of Wyeth, and no fee will be paid in the event the candidate is hired by Wyeth as a result of the referral or through other means. Note: Any search agreement entered into prior with Wyeth to January 2004 is hereinafter void.
Search firms are essential to the recruitment and staffing efforts at Wyeth and we value the partnerships we have built with our preferred vendors. For this reason, Wyeth has established and regularly maintains a preferred vendor list. Please note that even preferred vendors need to have a written search agreement signed by the Vice President, Strategic Staffing at Wyeth in place for the specific position in order for a fee to be paid for any candidate referrals. Requirements: Please see Job Description
Apply By Email:
Ref ID: 46475318
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Dir. PPU Quality Compliance
Manage and guide certification activities for third party contractors for production of drug substance and drug product. Key role is developing and approval of supply and quality agreements. Negotiate and troubleshoot issues with contractors to ensure goals and objectives are met. Partner with Quality Unit functions and PPUs in working with third party contractors to improve quality systems while ensuring cGMP compliance. Experience in auditing, vendor qualification, contract manufacturing and agency inspections.
Develop and approve supply contracts, quality / technical agreements with third party, contract test labs, raw material suppliers and secondary contractors. Negotiate and troubleshoot issues with contractors to ensure company goals and objectives are met. Manage the tracking of all quality agreements with the Quality Unit.
Partner with other Quality Unit functions, Manufacturing, Validation, Global Strategic Sourcing and other Wyeth organizations in working with third party contractors on compliance issues with our agreements. Participate as a resource on project teams with third party contractors to evaluate and improve upon quality systems while ensuring cGMP compliance.
Accountable for managing and guidance of activities for third party contractors for product of drug substance and drug product. Work with Manufacturing, Validation, other Quality functions and third party contractors to direct, develop and complete certification activities.
Act as primary contact as Andover Quality Compliance Representative initiatives with regards to SCI Conformance Standards, Quality Agreements, Third Party Contractors, Cold Chain and Certification activities.
Reviews manufacturing and quality documentation to ensure compliance with cGMP standards. Develops and revises standard operating procedures as required.
Ensure third party contractors are held to same standards of quality compliance as the Wyeth organization.
Provide leadership role for Quality Unit operations as it relates to management of change control, training, deviations, performance metrics, trending, corrective and preventative action plans with third party contractors.Requirements:
A Minimum of a Bachelor's Degree (B.S./B.A.) in a scientific discipline. At least 8-15 years experience in a regulated biopharmaceutical environment in drug substance and drug product environment.
Experience in auditing, vendor qualification, contract manufacturing and regulatory agency inspections. Travel (approximately 10-2Wyeth offers competitive compensation and benefits programs including stock
options, child-care subsidies, flex-time, business casual attire,
educational assistance and professional development programs. Please
forward your resume with salary requirements and job reference code to the
address below.For more information, visit our website at
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