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.
Pay Rate Range
39 - 49 USD hourly
Additional Notes
Please note that contractors are engaged to provide services to Pfizer on a temporary basis in connection with a specific assignment. Contractors are hired and employed through Atrium, our third-party payrolling partner.
This job posting is for a temporary role as an employee of Atrium on assignment at Pfizer. The individual selected for this role will be offered the role as an employee of Atrium; compensation, medical benefits, fringe benefits and other terms and conditions of employment shall be presented by Atrium upon offer. The pay rate range provided is a reasonable estimate of the anticipated compensation range for this job at the time of posting. The actual pay rate will be based on a number of factors, including skills, competencies, experience, location and/or being pursued and other job-related factors permitted by law. In addition, this role will be eligible for overtime pay, in accordance with federal and state requirements.
Benefits Information
Comprehensive Benefits Package available based on eligibility
Medical, Dental, Vision
Short-Term Disability (STD)
Long-Term Disability (LTD)
Supplemental and Voluntary Life Insurance
401(K)
Commuter Benefit Program
