Senior Director, Regulatory Compliance, Large Molecule (USA)

Role 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.

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 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 be compliant with regulatory expectations.

Education

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

Qualifications

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

Skills

• Knowledge of 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 regulatory agencies or health authorities (e.g., US FDA, MHRA).
• Strong leadership of both direct and indirect teams to achieve objectives.
• Ability to balance technical knowledge with a compliance-driven perspective and business judgment.

Additional Requirements

• Travel on the job: up to 40% domestically and internationally.
• The position may not be performed remotely.