Senior Director, External Manufacturing Regulatory Compliance

Role: Senior Director, External Manufacturing Regulatory Compliance Oversight at Johnson & Johnson, leading enterprise-level compliance oversight across the External Manufacturing network for Innovative Medicine. Responsibilities: develop and mature compliance oversight strategies, provide independent risk assessments, oversee inspection readiness, monitor regulatory trends, and ensure effective cross-functional collaboration with Quality, Supply Chain, Regulatory, and others. Lead organizational learning, governance, and proactive risk management to safeguard product quality, patient safety, and regulatory adherence. Qualifications: Bachelor's in life sciences, engineering, pharmacy, or related; 15+ years in pharma, biotech, or biologics GMP environments; 10+ years in leadership, with experience managing global external manufacturing compliance programs, supporting regulatory inspections, and supplier oversight. Preferred: advanced degree, extensive experience with Health Authorities, CMO oversight, risk assessment tools, and GMP standards. HighValue: emphasis on external manufacturing compliance, inspection readiness, risk mitigation, and global regulatory interactions within innovative medicine sectors. WorkSetup: based in multiple US locations, with a focus on enterprise-wide strategic influence and leadership.