Senior Director, External Manufacturing Regulatory Compliance

Role: Senior Director of External Manufacturing Regulatory Compliance Oversight, responsible for enterprise-level leadership in ensuring compliance across Johnson & Johnson's external manufacturing network. Objectives include strengthening regulatory oversight, mitigating risks, and ensuring inspection readiness. Responsibilities encompass developing compliance strategies, providing independent risk assessments, overseeing inspection preparedness, and fostering cross-functional collaboration with Quality, Supply Chain, Regulatory Affairs, and Technical Operations. The role emphasizes proactive risk management, governance, and organizational learning, with a focus on external manufacturing partners such as contract manufacturers and suppliers.

Qualifications: Bachelor’s degree in life sciences, engineering, pharmacy, or related field; advanced degree preferred. Minimum 15 years’ experience in pharmaceutical, biotech, or related GMP environments, with at least 10 years in leadership roles overseeing external manufacturing or compliance programs. Proven expertise in GMP, supplier quality systems, inspection readiness, and global regulatory interactions is required.

High-Value Specifics: Focused on compliance oversight in biologics, advanced therapies, or pharmaceuticals within an international regulatory context. The role involves risk assessment, inspection readiness, and oversight of external partners, emphasizing a risk-based, enterprise-connected compliance model.

Work Setup: The role is based in multiple US locations (Pennsylvania, New Jersey) and involves influencing across a highly matrixed, global network. Specific travel requirements are not detailed, but the nature of oversight suggests some travel is expected.