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Assoc Dir QA Investigations
| Details |
Country: USA
Location: Andover MA
Total applied: 40
Location: US-MA-Andover Company:Wyeth Job Description:
Job Summary:
This position in the QA Investigations function at the Supply Partnership Site (SPS) requires a self motivated individual with strong interpersonal skills to serve as system owner and manager of external supply Investigations at both the contract manufacturing sites and internally to Wyeth. In addition, this position will be responsible for managing 2 direct reports.
Candidate should have excellent communication skills, a high level of attention to detail, and have the ability to work in a fast-paced environment.
Job Duties & Responsibilities:
Responsible for the QA review and closure of investigations with TW.
Actively participate in the migration of investigations form Track Wise to SAP representing SPS.
Ensure compliance of the investigations system with QSE 05, QSE 19, applicable Board of Health regulations, and accepted industry practice.
Partiners with QA Operations Investigations group to assure consistency across the Andover and SP sites.
Collaborates with PPU management to ensure investigation quality is maintained in a state of inspection readiness while investigation cycle time is optimized to meet or exceed management metrics.
Reports investigations related metrics to Site Quality Council as required by the Integrated Management Report, applicable conformance standards and SOPs.
Facilitates the Investigations Collaboration Group as a means of driving continuous improvement and facilitating multi-site communication.
Acts as the technical lead for investigations related projects.
Participate in the North American Investigation Users group.
Requirements:
A Minimum of a Bachelor's Degree with at least 10 years experience in the biotechnology, pharmaceutical, or medical device industry. Must have experience in reviewing or processing compliance investigations. Must have supervisory experience. A candidate with demonstrated project management, presentation, technical writing, and negotiation skills is preferred
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: 46768709
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|
Assoc Dir QA Investigations
Job Summary: This position in the QA Investigations function at the Supply Partnership Site (SPS) requires a self motivated individual with strong interpersonal skills to serve as system owner and manager of external supply Investigations at both the contract manufacturing sites and internally to Wyeth. In addition, this position will be responsible for managing 2 direct reports.
Candidate should have excellent communication skills, a high level of attention to detail, and have the ability to work in a fast-paced environment.Job Duties & Responsibilities:
Responsible for the QA review and closure of investigations with TW.
Actively participate in the migration of investigations form Track Wise to SAP representing SPS.
Ensure compliance of the investigations system with QSE 05, QSE 19, applicable Board of Health regulations, and accepted industry practice.
Partiners with QA Operations Investigations group to assure consistency across the Andover and SP sites.
Collaborates with PPU management to ensure investigation quality is maintained in a state of inspection readiness while investigation cycle time is optimized to meet or exceed management metrics.
Reports investigations related metrics to Site Quality Council as required by the Integrated Management Report, applicable conformance standards and SOPs.
Facilitates the Investigations Collaboration Group as a means of driving continuous improvement and facilitating multi-site communication.
Acts as the technical lead for investigations related projects.
Participate in the North American Investigation Users group.Requirements:
A Minimum of a Bachelor's Degree with at least 10 years experience in the biotechnology, pharmaceutical, or medical device industry. Must have experience in reviewing or processing compliance investigations. Must have supervisory experience. A candidate with demonstrated project management, presentation, technical writing, and negotiation skills is preferredWyeth 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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