QA Compliance and Regulatory Director

Role: Lead site Quality Operations to ensure regulatory compliance, quality standards, and continuous improvement in a biopharmaceutical manufacturing environment. Responsibilities: oversee compliance and regulatory activities including inspection readiness, audits, self-inspections, CMC filings, risk management, and facility support; lead and develop a team, foster a strong quality culture, and support site management reviews. Qualifications: Bachelor's degree in Engineering, Chemistry, Microbiology, or related field; 15+ years in GMP manufacturing of biologics, pharmaceuticals, or medical devices; 5+ years of senior leadership experience; strong knowledge of cGMPs, GxP, and regulatory standards; proven project management, negotiation, and communication skills. Preferred: Lean Six Sigma Black Belt certification. High-Value: focus on compliance, inspection readiness, CMC support, and risk management within biologics or pharma manufacturing; leadership role with strategic impact on audit and inspection outcomes, aligning with regulatory standards. WorkSetup: not specified; likely on-site based on facility oversight.