Senior Director, External Manufacturing Regulatory Compliance

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

As guided by Our Credo Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson we respect the diversity and dignity of our employees and recognize their merit.

Job Function:

Legal & Compliance

Job Sub Function:

Enterprise Compliance

Job Category:

People Leader

All Job Posting Locations:

Horsham Pennsylvania United States of America Malvern Pennsylvania United States of America New Brunswick New Jersey United States of America Raritan New Jersey United States of America Spring House Pennsylvania United States of America

Job Description:

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.

Mission:

Strengthen regulatory compliance across the External Manufacturing network by providing independent enterprise oversight increasing visibility of significant and emerging risks enabling timely escalation and governance challenging the sustainability of remediation and ensuring that relevant insights and lessons travel across partners platforms and the broader organization.

Leadership Expectations:

Enterprise Compliance Leadership

• Advance IMRC from reactive support toward proactive enterprise compliance leadership.

• Promote risk anticipation transparency accountability and early escalation.

• Maintain independent oversight while partnering effectively with accountable business and Quality functions.

• Connect external partner risks to product platform network patient regulatory and supply implications.

• Lead through influence across a highly matrixed and globally distributed network.

Strategic Influence and Decision Support

• Provide an independent compliance perspective on significant External Manufacturing decisions and risks.

• Assess regulatory and enterprise implications of local or partner-specific issues.

• Adviseleadership on compliance risks potential mitigation options and residual risk.

• Support alignment when compliance patient supply and business considerations require cross-functional decisions.

• Communicatesignificant risks clearly including when the message may be difficult or unpopular.

Enterprise Thinking and Organizational Capability

• Promote consistent approaches to risk visibility escalationinspectionreadiness and learning across the network.

• Prevent isolated partner issues from becoming broaderplatformor enterprise vulnerabilities.

• Build technical depth in External Manufacturing compliance oversight risk assessmentinspectionreadiness and governance.

• Develop succession strength inclusive leadership and enterprise perspective across the team.

Key Responsibilities:

External Manufacturing Compliance Strategy and Enterprise Integration

• 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.

Risk Visibility Escalation and Enterprise Oversight

• Establish mechanisms that improve identification visibility escalation monitoring and communication of significant External Manufacturing compliance risks.

• Support governance of significant risks through established enterpriserisk-managementprocesses.

• Assess and challenge whether risk framing adequately considers product quality patient safety regulatory compliance supply continuity and business impact.

• Identifysystemic vulnerabilities and cross-network patterns that may not beapparentwithin an individual partner relationship.

• Promotetimelyescalation 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.

Inspection Readiness and Health Authority Engagement Oversight

• 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.

Supplier and External Manufacturing Oversight Insights

• 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.

Cross-Functional Leadership & Integration

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.

Regulatory Intelligence Organizational Learning & Governance

• 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.

People Leadership & Culture

• 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.

Required Qualifications:

Education

• Bachelors Degree in life sciences engineering pharmacy or related field

• Advanced degree preferred

Experience

• 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 experiencesupporting 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.

• Experience interacting with global Health Authorities strongly preferred.

Knowledge Skills & Capabilities

• Deep understanding of External Manufacturing compliance risks and applicable GMP expectations.

• Strong knowledge of pharmaceutical quality systems supplier quality management risk-based oversightinspectionreadiness 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-thinkingcapability.

• Ability to balance independent compliance oversight with effective cross-functionalpartnership.

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.

Required Skills:

Preferred Skills:

Audit and Compliance Trends Audit Findings and Recommendations Compliance Management Compliance Policies Compliance Risk Confidentiality Controls Compliance Corporate Investigations Developing Others Inclusive Leadership Leadership Legal Function Legal Services Policy Development Risk Management Framework Tactical Planning

The anticipated base pay range for this position is :

$178000.00 - $307050.00

Additional Description for Pay Transparency:

Subject to the terms of their respective plans employees are eligible to participate in the Companys consolidated retirement plan (pension) and savings plan (401(k)).

This position is eligible to participate in the Companys long-term incentive program.

Subject to the terms of their respective policies and date of hire employees are eligible for the following time off benefits:
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 period10 days
Volunteer Leave 32 hours per calendar year
Military Spouse Time-Off 80 hours per calendar year

For additional general information on Company benefits please go to: - Experience:

Exec