Senior Director, External Manufacturing Regulatory Compliance

Role: Senior Director, External Manufacturing Regulatory Compliance Oversight, provides enterprise-level leadership for regulatory compliance within Johnson & Johnson's external manufacturing network. Objectives include strengthening compliance oversight, risk visibility, inspection readiness, and organizational learning. Responsibilities: develop and mature compliance strategies, oversee risk identification and escalation, ensure inspection preparedness, and lead governance efforts across external manufacturing operations, suppliers, and partners. Acts as the primary compliance liaison across functions such as Quality, Supply Chain, Regulatory Affairs, and Product Development; promotes a risk-based, proactive compliance culture; and supports regulatory interactions and inspection readiness initiatives. Qualifications: Bachelor's degree in life sciences, engineering, pharmacy, or related field; 15+ years in pharmaceutical, biotech, or biologics GMP environments; 10+ years in leadership roles involving external manufacturing or supplier oversight. Preferred experience includes supporting regulatory inspections, complex remediation, and global compliance programs. High-value specifics: large-scale pharmaceutical/biotech manufacturing, GMP compliance, inspection readiness, risk management, supplier oversight, and cross-functional leadership in a global matrix environment. Work setup: positions located in Horsham, PA; Malvern, PA; New Brunswick, NJ; Raritan, NJ; Spring House, PA, with a focus on strategic enterprise compliance leadership.