Quality Assurance & Compliance Lead — Pharma Audits & CAPA

Pfizer; Rochester (MI); On-site; USD 83,000 - 138,000; Full time

Benefits offered by this job

401(k) plan

Paid vacation

Health benefits

Holiday and personal days

Job summary

Pfizer is seeking a Quality Assurance professional to evaluate CAPA responses, ensure regulatory compliance, and support inspections. You will manage customer quality complaints, collaborate with sites and suppliers, and drive continuous improvement through data analysis and risk assessment.

The role emphasizes documentation, audits, and cross-functional coordination to uphold cGMP and quality standards across the network. Strong writing and communication skills are essential.

Qualifications

• Experience conducting quality investigations in pharmaceutical manufacturing.
• Strong understanding of Quality System functions and regulatory expectations.
• Excellent technical writing, communication, and presentation skills.

Responsibilities

• Evaluate CAPA responses for adequacy, effectiveness, and timely completion.
• Maintain quality system records as current and compliant with regulatory requirements.
• Prepare for regulatory inspections and audits with timely action plans.
• Manage customer quality complaints with thorough root-cause analysis.

Skills

CAPA investigations

Quality investigations

Regulatory audits

Statistics

MS Office

MS Project

Data interpretation

Education

BA/BS in related field

Tools

Statistical Software

Electronic lab systems

Job description

Pfizer is seeking a Quality Assurance professional to evaluate CAPA responses, ensure regulatory compliance, and support inspections. You will manage customer quality complaints, collaborate with sites and suppliers, and drive continuous improvement through data analysis and risk assessment.

The role emphasizes documentation, audits, and cross-functional coordination to uphold cGMP and quality standards across the network. Strong writing and communication skills are essential.