Senior QA & Compliance Strategist for Pharma

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

Benefits offered by this job

401(k) contributions

Pfizer Retirement Savings Contribution

Paid vacation

Holiday and personal days

Health benefits (medical, prescription

dental and vision

Job summary

Pfizer Inc. is seeking a Quality Assurance professional to evaluate CAPA responses, maintain compliance with cGMP, and support regulatory inspections worldwide.

You will manage quality systems, collaborate with manufacturing sites and suppliers, and ensure timely closure of corrective actions. The role emphasizes investigating customer quality complaints, performing root-cause analyses, and compiling reports and metrics for management.

Qualifications

• Quality investigations related to pharmaceutical or medical device manufacturing processes
• Strong understanding of Quality System functions, manufacturing and packaging processes, validations, engineering drawings, and basic statistical processes
• Ability to apply mathematical concepts, particularly statistics and probability, to Quality Engineering tasks
• Excellent technical writing, communication, and presentation skills
• Proficiency in Microsoft Office, Microsoft Project, and Statistical Software
• Experience in preparing and participating in audits and inspections

Responsibilities

• Evaluate corrective and preventive action (CAPA) responses for adequacy, effectiveness, and timely completion
• Ensure Quality Assurance policies, procedures, and quality system records are current and compliant
• Prepare for and support regulatory inspections, internal audits, supplier audits, and quality assessments
• Manage, investigate, and document customer quality complaints for commercial drug products
• Collaborate with internal stakeholders, manufacturing sites, suppliers, contract manufacturers, and quality partners
• Support the Supplier Quality Management Program through supplier qualification, monitoring, and action management
• Assist with technical investigations involving product, process, component, and equipment-related quality issues
• Collect, analyze, interpret, and trend quality and operational data to identify opportunities for improvement
• Review quality system documentation and performance metrics to identify emerging issues
• Promote compliance with cGMP, regulatory requirements, data integrity, and company procedures
• Support quality investigations, deviation management, change management, and corrective actions
• Prepare reports, presentations, and quality metrics for management and stakeholders

Job description

Pfizer Inc. is seeking a Quality Assurance professional to evaluate CAPA responses, maintain compliance with cGMP, and support regulatory inspections worldwide.

You will manage quality systems, collaborate with manufacturing sites and suppliers, and ensure timely closure of corrective actions. The role emphasizes investigating customer quality complaints, performing root-cause analyses, and compiling reports and metrics for management.