Senior Director, Regulatory Compliance, Molecule

Overview

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and Med Tech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.

Learn more at

Job Function: Legal & Compliance

Job Sub Function: Enterprise Compliance

Job Category: People Leader

Horsham, Pennsylvania, United States of America;
Raritan, New Jersey, United States of America

Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s).

• USA Req#: R-052414
• Switzerland Req#: R-052854
• Belgium/Netherlands Req#: R-052851

Johnson & Johnson is the world’s most comprehensive and broadly based manufacturer of health care products, as well as a provider of related services for the pharmaceutical and medical technologies professional markets. J&J employs approximately 126,500 people worldwide, deployed in more than 250 operating companies in 60 countries.

Reporting to the Vice President, Innovative Medicine Regulatory Compliance Leader, this role leads a team of compliance professionals and is part of the IM Compliance Leadership Team. The Senior Director is the GMP compliance leader for Large Molecule Biologics across the Platform and is accountable for inspection readiness, audit programs, supplier/CMO support, and maintaining a robust compliance program. The position partners closely with Quality, CMC/Regulatory Affairs, Manufacturing, Supply Chain, R&D, Clinical and Corporate Compliance to ensure product quality, patient safety, and uninterrupted supply.

• Define and lead a global GMP compliance strategy for Large Molecule biologics that aligns with IM Compliance objectives and business priorities.
• Translate strategy into an annual compliance roadmap with measurable milestones, resource plans and KPIs tied to inspection readiness.
• Oversee compliance across all stages of the biologic’s lifecycle, from production to storage and distribution.
• Ensure that suitable GMP controls are implemented for each type of system.
• Maintain continuous inspection readiness across internal manufacturing sites, CMOs, analytical labs and key suppliers; lead inspection planning, mock inspections, readiness assessments, cross-functional briefings and response coordination.
• Act as primary or co-lead for interactions with health authorities (e.g., US FDA, EMA, MHRA, PMDA), including drafting inspection responses, preparing submission-related GMP evidence and negotiating remediation plans.
• Design and direct a risk-based audit program covering manufacturing sites; oversee audit scope, execution, findings resolution, CAPA effectiveness verification and trending.
• Lead risk identification, assessment and mitigation across biologics manufacturing and support functions; prioritize remediation to reduce patient and regulatory risk while maintaining supply.
• Provide compliance input for regulatory filings, pre-submission meetings and responses to agency questions relative to GMP/CMC readiness and inspection history.
• Build and lead a high-performing Large Molecule compliance team; define competency frameworks and deliver targeted GMP training for manufacturing, analytical and supplier organizations to raise compliance maturity. Promote a culture of quality-first decision making, transparent escalation and continuous improvement across the platform.
• Drive continuous improvement initiatives to reduce repeat findings, enhance process robustness and shorten time-to-release while being compliant with regulatory expectations.

• Bachelor of Science…