Sr. Associate, Contractor Quality Regulatory Lead
Summary:
The Contractor Quality & Regulatory Lead (CQRL) supports Pfizer's external supply network by ensuring Contract Manufacturing Organizations (CMOs) and suppliers consistently deliver high-quality products in compliance with global GMP/GDP regulations, internal quality standards, and applicable regulatory requirements.
This role serves as the key liaison between external manufacturing partners and Pfizer internal teams, including Global Regulatory Science (GRS), Global CMC, and Virtual Site Operating Teams (VSOT). The CQRL is responsible for managing quality oversight activities, driving regulatory change management, and ensuring compliant execution of product lifecycle activities across a portfolio of outsourced products.
Job Responsibilities:
Provide end-to-end quality oversight for external CMOs and suppliers, ensuring compliance with GMP/GDP requirements.
Lead and support change control processes, including regulatory impact assessments and Post Approval Changes (PACs).
Partner with regulatory and CMC teams to determine regulatory filing requirements, submission strategies, and implementation timelines.
Review and approve key quality documentation, including Annual/ Product Quality Reviews (APR/PQR), stability reports, and change control records.
Support audits, regulatory inspections, compliance assessments, and complex quality investigations.
Manage quality agreements and support onboarding, product launches, site transfers, and lifecycle changes for external manufacturers.
Track, escalate, and resolve quality and regulatory issues, ensuring timely execution and compliance across global stakeholders.
Ensure accurate documentation and system updates within eQMS and related quality/regulatory systems.
Skills:
Minimum 5+ years of experience in a GMP-regulated pharmaceutical or biotech environment.
Strong background in Quality Assurance, Regulatory Affairs, or CMC / Technical Operations.
Experience working with external suppliers, CMOs, or contract manufacturing networks.
Solid understanding of GMP/GDP regulations and global regulatory frameworks.
Experience with change control, regulatory impact assessments, and quality system management.
Familiarity with quality systems (eQMS) and regulatory documentation processes preferred.
Strong communication, stakeholder management, and cross-functional collaboration skills.
Ability to work independently in a global, matrixed environment.