Director, Regulatory Compliance – BioT

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Job Description:

J&J is recruiting for a Director, Regulatory Compliance – BioT reporting to the Sr Dr Regulatory Comp, Large Molecule.

Position Summary

The Director, Regulatory Compliance is the senior Site-Based Compliance leader responsible for providing independent compliance leadership, maintaining visibility of the site compliance-risk posture, promoting continuous inspection readiness, enabling timely escalation, and strengthening organizational learning at a Biotherapeutics manufacturing site.

The role serves as a strategic compliance partner to Site Leadership, Quality, Manufacturing, MSAT, Engineering, Supply Chain, Regulatory Affairs, and Quality Control. The Director brings an independent regulatory compliance perspective to significant risks and decisions and helps connect site signals to platform and enterprise priorities.

The role requires deep knowledge of biologics manufacturing operations and the regulatory and operational risks associated with aseptic processing, cell culture operations, downstream purification, viral safety, contamination-control strategies, environmental monitoring, process validation, technology transfer activities, and product lifecycle management.

As a people leader, the Director builds and develops a high-performing compliance organization and strengthens compliance capability across the site.

Mission of the Role

Enable the site to maintain a sustained state of compliance and inspection readiness by providing proactive and independent compliance leadership, strengthening risk visibility, enabling effective governance and escalation, and fostering prevention, transparency, and continuous improvement.

Provide Strategic Site Compliance Leadership

Bring an independent regulatory compliance perspective to significant site priorities and decisions, including:

• Inspection readiness and regulatory risk
• Product launch readiness and technology transfers
• Capacity expansion and facility modifications
• Major deviations, quality events, and data integrity concerns
• Supply continuity risks and enterprise compliance initiatives
• Potential regulatory reporting events, without assuming formal reportability decision ownership

Drive Enterprise Thinking and Organizational Capability

• Connect significant site risks to platform and enterprise risks.
• Promote consistent risk identification, escalation, and cross-site learning.
• Support implementation of enterprise compliance priorities and transformation initiatives.
• Develop strong compliance talent and coach leaders on risk-based decision-making.
• Strengthen inspection-readiness capability and a culture of transparency, accountability, and prevention.

Key Responsibilities

1. Compliance Risk Visibility & Site Risk Leadership

Provide an independent regulatory compliance perspective on the site compliance-risk posture and support effective visibility, prioritization, escalation, and governance of significant risks.

Relevant risk areas may include:

• Aseptic processing
• Cell culture operations
• Downstream purification
• Viral safety controls
• Environmental monitoring
• Data integrity
• Validation lifecycle management
• Technology transfers
• Product complaints
• Supplier performance
• Regulatory commitments
• Process performance
• Sterility assurance
• Supply continuity

2. Inspection Readiness & Regulatory Oversight

Provide independent oversight of continuous inspection readiness in partnership with Site Quality and accountable functions.

Biotherapeutics Focus Areas

Particular attention is given to:

• Aseptic manufacturing operations
• Cell culture and fermentation systems
• Downstream purification operations
• Viral safety controls
• Contamination-control strategies
• Annex 1 implementation
• Environmental monitoring programs
• Process validation and lifecycle management
• Continued Process Verification (CPV)
• Sterility assurance systems
• Multi-product biologics operations
• Technology transfers and commercialization activities

3. Biotherapeutics Manufacturing Compliance Oversight

Provide compliance leadership for Biotherapeutics manufacturing operations.

Key Areas

• Upstream manufacturing
• Cell culture operations
• Downstream purification
• Drug substance manufacturing
• Drug product manufacturing
• Sterile operations
• Utilities and facilities
• Environmental monitoring
• Process validation
• Continued Process Verification (CPV)
• Technology transfers
• Product launches
• Validation lifecycle management

4. People Leadership

Lead, coach, and develop a high-performing site compliance organization.

• Lead, coach, and develop Site-Based Regulatory Compliance staff.
• Recruit and develop talent aligned with Biotherapeutics compliance needs.
• Establish performance objectives aligned with IMRC priorities and future ways of working.
• Build capability in inspection readiness, risk visibility, escalation, governance, compliance analytics, regulatory strategy, and biologics manufacturing.
• Develop succession plans and foster an inclusive, accountable, and high-performing culture.

Qualifications

Education

• Bachelor's degree in Biotechnology, Biological Sciences, Pharmacy, Engineering, Chemistry, Microbiology, Biochemistry, or related scientific discipline.
• Advanced degree preferred.

Experience

• 12+ years of pharmaceutical or biotechnology experience.
• 5+ years of leadership experience.
• Significant experience in biologics manufacturing operations, quality, compliance, or regulatory oversight.
• Experience supporting FDA, EMA, MHRA, PMDA, or other global health authority inspections.
• Strong understanding of:
  • Biologics manufacturing operations
  • Aseptic processing
  • Cell culture and downstream processing
  • Annex 1 requirements
  • Process validation and lifecycle management
  • Data integrity
  • Quality systems
  • Inspection readiness
  • Sterility assurance and contamination control
  • Technology transfers and commercialization activities

Required Skills:

Preferred Skills: