Quality Product Lead

Senior Quality Specialist position at a pharmaceutical company responsible for ensuring product quality and regulatory compliance in GMP manufacturing environments. Lead quality initiatives, conduct investigations, and manage corrective actions while maintaining adherence to global regulatory standards.

Responsibilities

• Provide technical leadership and oversight for GMP manufacturing quality environments
• Conduct risk assessments, lead quality investigations, and manage corrective and preventive actions
• Serve as subject matter expert ensuring adherence to global regulatory requirements
• Drive quality excellence initiatives and continuous improvement across operations
• Collaborate cross-functionally to maintain robust quality systems and processes

Requirements

• Advanced degree with 6+ years or bachelor's degree with 8+ years in GMP-regulated pharmaceutical/biotech quality assurance
• Professional certifications such as ASQ CQE or CQA
• Expert knowledge of FDA, EMA, and global GMP regulations including 21 CFR Parts 210/211 and ICH guidelines
• Demonstrated proficiency in quality systems including investigations, CAPAs, and change control
• Experience with risk assessment methodologies and root cause analysis techniques
• Strong technical writing skills and proficiency with quality management systems
• Experience hosting regulatory inspections and customer audits preferred

Compensation: $104,100–$156,100 base