Senior Director, External Manufacturing Regulatory Compliance

Johnson & Johnson Innovative Medicine•Horsham, PA

3d•$178,000 - $307,050•Hybrid

About The Position

The Senior Director, External Manufacturing Regulatory Compliance Oversight, provides enterprise-level regulatory compliance leadership, independent compliance oversight, risk visibility, governance support, escalation leadership, inspection-readiness oversight, and organizational learning across the Innovative Medicine External Manufacturing network. The role serves as the primary IMRC leader for External Manufacturing and provides an independent compliance perspective on significant risks, inspection readiness, supplier oversight programs, remediation strategies, emerging regulatory expectations, and external manufacturing network changes. The Senior Director works across Quality, External Manufacturing Operations, Supply Chain, Procurement, Regulatory Affairs, Product Development, Technical Operations, MSAT, platform compliance leaders, and business leadership to help identify significant compliance risks early, strengthen decision quality, and connect local partner signals to platform and enterprise priorities. As a member of the IMRC Leadership Team, the Senior Director builds and develops a high-performing External Manufacturing compliance organization and advances a proactive, risk-based, and enterprise-connected compliance model.

Requirements

Bachelor’s Degree in life sciences, engineering, pharmacy, or related field
Minimum 15 years of pharmaceutical, biotechnology, biologics, advanced therapy, medical device, or combination-product GMP experience.
Minimum 10 years of leadership experience in Quality, Compliance, Regulatory Compliance, External Manufacturing, or supplier oversight.
Demonstrated experience leading global compliance or oversight programs involving external manufacturing partners.
Significant experience supporting major regulatory inspections, complex remediation, and cross-functional risk decisions.
Experience with supplier quality systems, CMO oversight, inspection readiness, CAPA governance, deviation management, risk management, and regulatory compliance programs.
Deep understanding of External Manufacturing compliance risks and applicable GMP expectations.
Strong knowledge of pharmaceutical quality systems, supplier quality management, risk-based oversight, inspection readiness, and enterprise governance.
Ability to translate complex compliance risks into clear business-relevant insights and options.
Ability to influence without direct authority in a highly matrixed global environment.
Strong executive presence, communication, analytical judgment, and strategic-thinking capability.
Ability to balance independent compliance oversight with effective cross-functional partnership.

Nice To Haves

Advanced degree preferred
Experience interacting with global Health Authorities strongly preferred

Responsibilities

Develop and continuously mature the IMRC External Manufacturing compliance oversight strategy in alignment with IMRC objectives and Innovative Medicine priorities.
Define risk-based principles and expectations for independent compliance oversight across contract manufacturers, contract laboratories, strategic partners, critical suppliers, and other outsourced operations.
Maintain enterprise visibility of significant External Manufacturing compliance risks, inspection-readiness concerns, remediation themes, and emerging signals.
Provide an independent compliance perspective on new partnerships, acquisitions, technology transfers, product launches, and network changes.
Promote consistency across platforms while recognizing differences in product, technology, lifecycle stage, and business model.
Establish mechanisms that improve identification, visibility, escalation, monitoring, and communication of significant External Manufacturing compliance risks.
Support governance of significant risks through established enterprise risk-management processes.
Assess and challenge whether risk framing adequately considers product quality, patient safety, regulatory compliance, supply continuity, and business impact.
Identify systemic vulnerabilities and cross-network patterns that may not be apparent within an individual partner relationship.
Promote timely escalation of significant risks and visibility of ownership, decisions, follow-through, and residual risk.
Evaluate recurring observations, inspection themes, remediation concerns, and external signals for broader applicability.
Provide independent oversight of inspection readiness across the External Manufacturing network.
Assess and challenge significant readiness risks involving critical suppliers, contract manufacturers, contract laboratories, and strategic partners.
Support risk-based readiness reviews, mock inspections, and simulation exercises in partnership with Supplier Quality and accountable functions.
Provide an independent compliance perspective for Health Authority inspections and regulatory interactions involving outsourced operations.
Monitor visibility and escalation of significant readiness gaps, regulatory commitments, and partner remediation risks.
Promote deployment of relevant inspection learnings and preventive actions across the network.
Provide an independent compliance perspective across risk-based oversight programs involving contract manufacturers, contract testing laboratories, external sterilization providers, critical API and raw-material suppliers, device and combination-product suppliers, and strategic development partners.
Assess whether oversight approaches appropriately reflect partner risk profile, product and patient impact, business criticality, regulatory history, and lifecycle stage.
Review enterprise trends involving inspections, deviations, complaints, remediation, regulatory commitments, and supplier performance.
Challenge the adequacy of compliance-risk mitigation and remediation strategies for significant partner issues.
Serve as the primary compliance liaison for external manufacturing across: External Manufacturing Operations, Supply Chain, Procurement, Quality, Regulatory Affairs, Product Development, Technical Operations, Manufacturing Science & Technology.
Partner with platform compliance leaders to ensure consistent application of compliance standards.
Align external manufacturing compliance strategies with business continuity and supply assurance objectives.
Monitor external regulatory trends, warning letters, inspection observations, and emerging compliance risks impacting outsourced manufacturing.
Ensure external learnings are translated into enterprise assessments and preventive actions.
Lead deployment of lessons learned across the external manufacturing network.
Drive implementation of governance processes that increase transparency, accountability, and organizational learning.
Present emerging risks, strategic issues, and compliance trends through executive governance forums.
Build and lead a high-performing external manufacturing compliance organization.
Create a culture focused on: Proactive risk identification, Early escalation, Risk-based decision-making, Compliance excellence, Accountability for outcomes, Enterprise thinking.
Develop team capabilities in: Supplier oversight, Inspection readiness, Risk management, Regulatory intelligence, CAPA effectiveness, Enterprise governance.
Coach and develop Directors and Managers responsible for regional and platform oversight activities.

Benefits

Consolidated retirement plan (pension)
Savings plan (401(k))
Long-term incentive program
Vacation –120 hours per calendar year
Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
Holiday pay, including Floating Holidays –13 days per calendar year
Work, Personal and Family Time - up to 40 hours per calendar year
Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
Caregiver Leave – 80 hours in a 52-week rolling period
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year