Senior Director, Regulatory Compliance, Large Molecule (USA)

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are our expertise in Innovative Medicine and MedTech 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 more at

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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

• Belguim/Netherland Req#: R-052851

Johnson & Johnson is the worlds 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 126500 people worldwide deployed in more than 250 operating companies in 60 countries.

Position Summary:

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.

Major Duties & Responsibilities:

• 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 biologics 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 be compliant with regulatory expectations.

Education Requirement

• Bachelor of Science degree preferred; advanced degree (MS PhD) desirable.

Professional Experience

• Experience providing remediation support for organizations facing FDA Warning Letters or Consent Decrees preferred.

• Background working with agencies such as the US FDA EMA or MHRA in the context of biologics manufacturing.

• Hands-on operational knowledge of cell banks upstream cell culture downstream purification analytical labs and CMOs for biologics.

• Experience as an Investigator for the US FDA is also acceptable.

Knowledge Skills and Abilities

• Expertise in biologics modalities viral clearance/inactivation strategies potency/assay strategy stability and comparability assessments.

• Demonstrated success implementing inspection readiness audit programs and vendor oversight for large molecule products.

• Proven experience collaborating with or working for regulatory agencies or health authorities such as the US FDA or MHRA.

• A proven record of leading both direct and indirect teams to accomplish objectives and deliver results.

• Ability to balance technical knowledge of products and processes with a compliance-driven perspective and sound business judgment.

People Management Experience

• Candidates must have a minimum of 10 years of experience managing people including building and developing technical compliance teams.

Travel on the Job: up to 40% domestically and internationally.

The position may not be performed remotely.

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race color religion sex sexual orientation gender identity age national origin disability protected veteran status or other characteristics protected by federal state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants needs. If you are an individual with a disability and would like to request an accommodation please email the Employee Health Support Center () or contact AskGS to be directed to your accommodation resource.

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