Senior Quality Assurance Compliance Specialist

Senior Quality Assurance Compliance Specialist at Pfizer responsible for evaluating corrective actions, managing regulatory compliance, investigating product complaints, and supporting supplier quality programs. This role ensures pharmaceutical manufacturing meets cGMP standards and regulatory requirements.

Responsibilities

• Evaluate CAPA responses to audit observations for adequacy, effectiveness, and timely completion
• Manage customer quality complaints and conduct root cause analysis within global complaints management system
• Support regulatory inspections, internal audits, and supplier audits with action plan development and closure
• Analyze quality and operational data using statistical and risk-based methods to identify improvement opportunities
• Collaborate with internal teams, manufacturing sites, and suppliers on complaint investigations and quality compliance

Requirements

• High school diploma with 8+ years of quality experience, or associate's degree with 6+ years, or bachelor's degree with 2+ years
• Demonstrated experience conducting and documenting quality investigations in pharmaceutical or medical device manufacturing
• Strong understanding of quality systems, manufacturing processes, validations, and statistical methods
• Proficiency in Microsoft Office, Microsoft Project, and statistical software
• Excellent technical writing and communication skills
• Experience preparing for and participating in audits and regulatory inspections

Compensation: $82,700-$137,900 base salary plus 10% bonus target