Senior Director, Regulatory Compliance, Molecule

Role Summary

Senior Director, Regulatory Compliance, Large Molecule Biologics. Reports to the Vice President, Innovative Medicine Regulatory Compliance Leader. Leads a team of compliance professionals and serves on the IM Compliance Leadership Team. Acts as GMP compliance leader for Large Molecule Biologics across the Platform, accountable for inspection readiness, audit programs, supplier/CMO support, and maintaining a robust compliance program. Partners with Quality, CMC/Regulatory Affairs, Manufacturing, Supply Chain, R&D, Clinical and Corporate Compliance to ensure product quality, patient safety, and uninterrupted supply.

Location:

Horsham, Pennsylvania;
Raritan, New Jersey.

• Define and lead a global GMP compliance strategy for Large Molecule biologics aligned with IM Compliance objectives and business priorities.
• Translate strategy into an annual compliance roadmap with milestones, resource plans and KPIs tied to inspection readiness.
• Oversee compliance across all stages of the biologic lifecycle, from production to storage and distribution.
• Ensure suitable GMP controls are implemented for each type of system.
• Maintain continuous inspection readiness across internal 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 (US FDA, EMA, MHRA, PMDA), including drafting inspection responses, preparing GMP evidence and negotiating remediation plans.
• Design and direct a risk-based audit program covering manufacturing sites; oversee 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 related 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; promote a culture of quality-first decision making, transparent escalation and continuous improvement.
• Drive continuous improvement initiatives to reduce repeat findings, enhance process robustness and shorten time-to-release while remaining compliant with regulatory expectations.

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

• 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 acceptable.
• 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 such as the US FDA or MHRA.
• Proven track record of leading both direct and indirect teams to achieve objectives and deliver results.
• Ability to balance technical knowledge with a compliance-driven perspective and sound business judgment.
• People management experience: minimum of 10 years managing people and building/developing technical compliance teams.

• Expertise in biologics modalities, viral clearance/inactivation strategies, potency/assay strategy, stability and comparability assessments.
• Successful implementation of inspection readiness, audit programs and vendor oversight for large molecule products.
• Strong collaboration with regulatory agencies or health authorities (FDA, MHRA, EMA).
• Ability to lead cross-functional teams and deliver results with a compliance-focused mindset.

• Travel:
  Up to 40% domestically and internationally.
• The position may not be performed remotely.