Senior Quality Compliance & Regulatory Auditor

Pfizer; Michigan; On-site; USD 83,000 - 138,000; Full time

Benefits offered by this job

401(k) with company match

Health benefits

Paid vacation and leave

Job summary

Pfizer is seeking a quality assurance professional to join our on-site team in the United States. You will lead CAPA reviews, support regulatory inspections, and manage customer quality complaints with rigorous root-cause analysis.

You will collaborate with manufacturing sites, suppliers, and quality partners to ensure compliant records and effective corrective actions, while promoting cGMP and data integrity across the site.

Qualifications

• Experience conducting quality investigations in pharmaceutical or medical device manufacturing.
• Strong knowledge of Quality System functions and manufacturing processes.
• Ability to apply statistics to Quality Engineering tasks.
• Excellent technical writing and communication skills.

Responsibilities

• Evaluate CAPA responses for adequacy and timely completion.
• Ensure QA policies and records comply with regulatory requirements.
• Prepare for regulatory inspections and audits with timely action plans.
• Manage and document customer quality complaints with root cause analysis.
• Collaborate with suppliers and internal stakeholders to complete investigations.
• Support quality investigations, deviation/change management, and continuous improvement.

Skills

Quality investigations

Quality systems

Audit readiness

Statistical analysis

Documentation & writing

Microsoft Office

Audits & inspections

Education

Bachelor's degree in a relevant field

Associate’s degree

BA/BS with 2+ years of experience

MBA/MS in a related field

Tools

Microsoft Project

Statistical Software

Quality Management Software

Job description

Pfizer is seeking a quality assurance professional to join our on-site team in the United States. You will lead CAPA reviews, support regulatory inspections, and manage customer quality complaints with rigorous root-cause analysis.

You will collaborate with manufacturing sites, suppliers, and quality partners to ensure compliant records and effective corrective actions, while promoting cGMP and data integrity across the site.