External Sply Quality Leader

As an External Supply Quality Leader, you will work with and provide support to Pharma External Supply for the procurement of active pharmaceutical ingredients and for the contract manufacturing of Wyeth finished drug products. You will work as part of product-specific Primary Processing Unit (PPU) teams, interacting with External Supply Operations, API Technology, Drug Product Technology, Wyeth Research, Strategic Sourcing, Regulatory Affairs, and other External Supply Quality Leaders. You will work closely with drug product contract manufacturers/packagers. You will travel up to 40 % of the time. As an External Supply Quality Leader, you will assure that the manufacturing, packaging, and testing of drug substances and drug products from external suppliers are in compliance to GMPs and in conformance to regulatory filings. You will assure that suppliers fully validate their operations related to the Wyeth APIs and drug products. You will assure that suppliers' Quality Control laboratories are conducting all analytical testing and stability testing accurately and consistent with Wyeth standards. You will assure that contract manufacturers and drug substance suppliers fulfill the requirements of their Quality/Technical/Supply Agreements with Wyeth. You will assure GMP compliance by suppliers. You will assure completeness and quality of qualification work performed by the supplier or contract manufacturer for technology transfer associated with product introduction or product change, and you will oversee change control by the suppliers. You will insure regulatory inspection readiness of the suppliers. You will engage the Wyeth recipients of the drug substances and drug products, and you will assure that the drug substances and drug products meet the recipient's requirements for manufacturing, shipping, packaging, testing and necessary documentation. You will resolve with the contract manufacturer any quality issues raised by the Wyeth recipient. If drug product is released by External Supply Quality Operations, you will procure and review necessary batch record documentation from contract manufacturer and resolve any deviations or issues with contract manufacturer. In addition, you will manage post-release quality of the drug product.This position requires a BS in Chemistry, Pharmacy or related science with 10 years experience in pharmaceutical development, manufacturing, or analytical testing. Experience in API and drug product manufacturing and controls is necessary.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
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