Sr. Manager Quality Audit and Compliance
Core
Leading internal and external GMP audit activities and maintaining robust quality systems for a pharmaceutical company's growing portfolio.
Role type
Senior Manager, Quality Assurance Compliance
Builds
Quality systems and compliance frameworks for pharmaceutical operations
Domain
Pharmaceutical / Biopharmaceutical / GxP
Required skills
GMP audit planning and execution, Quality Agreement negotiation, SOP development, regulatory compliance (FDA/EU/ICH), Computer System Validation (CSV), corrective action management, compliance trend analysis
Preferred skills
Experience with manufacturing facility audits, clinical development quality oversight, commercial activity quality support
Technologies
GxP quality systems, Computerized solutions for quality
Responsibilities
Plan, schedule, and conduct GMP compliance audits of Contract Service Providers and internal operations; Prepare and review audit reports and evaluate corrective actions; Oversee development and maintenance of Quality Agreements with CSPs; Maintain internal audit program and compile compliance metrics; Prepare and maintain Standard Operating Procedures (SOPs); Provide compliance expertise for recalls, field alerts, and annual product reviews; Support Computer System Validation (CSV) for quality solutions; Recommend updates to quality policies based on evolving regulations
Seniority
Senior Manager, hands-on leadership
