
Manager Compliance, PSSM Portfolio
Responsible for providing quality resources to Co-Development (CDT) and Pharm Sci Project (PSPT) Teams. May include direct support or deployment of resources to meet CDT/PSPT needs of the business. Lead quality input on strategic CDT/PSPT activities focused on the development programs generated within the PSSM-PCoE business (innovative and generic parenteral divisions). Provide leadership support to internal audits (e.g. RQA), regulatory inspections (e.g FDA, MHRA), qualification audit of 3rd party vendors and support PAI (Pre-Approval Inspection) readiness at commercial manufacturing facilities as needed. Lead definition/development and implementation of Quality integration activities for acquired entities and assets. This could include movement of compounds, personnel, and sites into the Pfizer network. Maintain strong partnerships with PSSM, GCS, GCMC, PGS and ESQ. Partner across PSQA and Pharm Sci business lines to support and progress joint or shared goals and initiatives. Perform job responsibilities in compliance with cGMP and all other regulatory agency requirements.
Minimum of 15 years Pharmaceutical experience
Previous supervisory experience is required
Experience with GMP compliance issues, associated with deviations or product defects
Oversight of 3rd party GMP service providers (manufacturing and testing).
Documentation
Quality Assurance
Time Management
Negotiation skills
GMP compliance issues
Process Improvement
Communication Skills
Multitasking Skills
Adaptability
Detail Oriented and Organized
According to JobzMall, the average salary range for a Manager Compliance, PSSM Portfolio in 275 N Field Dr, Lake Forest, IL 60045, USA is $80,000 to $105,000 per year.
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Pfizer Inc. is an American multinational pharmaceutical corporation headquartered in New York City, with its research headquarters in Groton, Connecticut. It is one of the world's largest pharmaceutical companies.

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