Senior Director, External Manufacturing Regulatory Compliance

Role: Lead enterprise regulatory compliance oversight for Johnson & Johnson's External Manufacturing network within the Innovative Medicine sector. Objectives include strengthening compliance programs, enhancing visibility of risks, supporting inspection readiness, and fostering organizational learning. Responsibilities encompass developing compliance strategies aligned with corporate goals, providing independent risk assessments, overseeing inspection readiness, and managing external manufacturing partner oversight across contract manufacturers, labs, and suppliers. The role demands collaboration with Quality, Supply Chain, Regulatory Affairs, and other functions to mitigate compliance risks proactively and ensure regulatory adherence. Qualifications: Bachelor's in life sciences, engineering, pharmacy, or related; 15+ years of GMP experience in pharma, biotech, or biologics, with at least 10 years in leadership roles involving external manufacturing and compliance oversight. Preferred expertise includes supporting major inspections, managing supplier quality systems, and experience with global health authorities. High-value specifics: focus on GMP compliance, external manufacturing oversight, inspection readiness, risk management, and cross-functional leadership in a global, matrixed environment. The position reports to senior leadership and involves strategic influence across the organization to embed proactive compliance culture.