QA Compliance Specialist

Responsible for leading, facilitating, negotiating and monitoring the Quality Agreement process for Contract Manufacturers, Contract Laboratories, Co-Manufacturers, Co-Testing Laboratories, Raw Materials, and Distributors for Andover Supply Partnership Site (SPS)

Provide routine reporting to Senior Management on status of Quality Agreements

Responsible for review and input to quality related aspects of Manufacturing/Supply Agreements

Lead the SPS TSE Assessment Group responsible for evaluating TSE systems at Contract Manufacturers and TSE risk to SPS products

Lead and guide certification activities for Third Party Contractors for drug substance and drug product

Work cross functionally internally to ensure that project requirements and project milestones are met

Develop and implement inspection readiness plans at Contract Manufacturers in preparation for regulatory inspections

Participate in Regulatory Agency on-site inspections and Pre-Approval inspections of Third Party Contractors as required

Perform internal audits for SPS and participate in GCA Audits at our Contract Manufacturers as SPS representative. Track and trend audit commitments and ensure completion of commitment activities.

Participate as an SME for compliance on project teams with Third Party Contractors to improve upon quality systems while ensuring cGMP compliance. Develop and revise standard operating procedures as required. Ensure Third Party Contractors are held to the same quality standards of compliance as the Wyeth organization.

Provide support and guidance to Change Control committee

Provide support and guidance as SPS Quality Compliance Representative in initiatives regarding SCI Conformance Standards, Quality Agreements, Third Party Contractors, Cold Chain and Certification activitiesQualifications:

BA/BS in Business or Scientific discipline. Minimum 6-8 years experience in Quality or Manufacturing in the pharmaceutical or biotech GMP regulated industries.

Team building and ability to influence without direct reporting relationship is essential to success

Experience in dealing with regulatory inspections

Project management, quality, and/or drug product experience desirable

Proven organizational and time-management skills

Collaboration, team leadership, results-oriented, flexibility, customer-focused, facilitation, problem solving, and interpersonal communication skills

Candidates must be proficient in MSWord, Excel, and Power Point.

Travel: 25-35%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