Remote Senior Contractor QA & Regulatory Lead for CMOs

Pfizer; United States; On-site; USD 53,726 - 67,502; Full time

Benefits offered by this job

Comprehensive Benefits Package available based on eligibility

Short-Term Disability (STD)

Long-Term Disability (LTD)

Supplemental and Voluntary Life Insurance

Job summary

Pfizer, located in the United States, is seeking a Sr. Associate, Contractor Quality Regulatory Lead, to oversee quality assurance within its external supply network. This role involves managing compliance with GMP/GDP regulations and collaborating closely with Contract Manufacturing Organizations (CMOs) and suppliers.

The ideal candidate will have over 5 years of experience in a GMP-regulated environment and a strong background in Quality Assurance or Regulatory Affairs. A comprehensive benefits package is available based on eligibility.

Qualifications

• 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.

Responsibilities

• Provide end-to-end quality oversight for external CMOs and suppliers.
• Lead and support change control processes including regulatory impact assessments.
• Partner with regulatory and CMC teams to determine regulatory filing requirements.
• Review and approve key quality documentation including Annual/Product Quality Reviews.

Skills

GMP/GDP regulations

Quality Assurance

Regulatory Affairs

Stakeholder management

Change control processes

Cross-functional collaboration

Job description

Pfizer, located in the United States, is seeking a Sr. Associate, Contractor Quality Regulatory Lead, to oversee quality assurance within its external supply network. This role involves managing compliance with GMP/GDP regulations and collaborating closely with Contract Manufacturing Organizations (CMOs) and suppliers.

The ideal candidate will have over 5 years of experience in a GMP-regulated environment and a strong background in Quality Assurance or Regulatory Affairs. A comprehensive benefits package is available based on eligibility.