Director, Enterprise Regulatory Compliance

About the role

Johnson & Johnson is seeking a Director, Enterprise Regulatory Compliance to join our Enterprise Regulatory Compliance Assessment team in New Brunswick, Raritan, Titusville, NJ, and Horsham, PA.

Responsibilities

• Serve as the Enterprise Regulatory Compliance Single Point of Contact and subject-matter leader for policy interpretation, issue triage, and decision support across pharmaceutical and medical device businesses.
• Provide independent assessments of manufacturing, quality, and compliance risks, supporting consistent application of global regulations, company standards, and policies across segments and sites.
• Independently review and classify Health Authority inspections and corporate cGMP audits to ensure consistency across businesses.
• Independently review and initiate issue management for Health Authority inspections and recalls across the pharmaceutical and medical device businesses following escalation policies and standards.
• Support inspection readiness activities in preparation for Health Authority and Notified Body audits and pre-approvals.
• Analyze large volumes of regulatory compliance data to identify actionable insights and lead periodic data-driven compliance reviews for senior executive leadership.
• Lead enterprise interpretation, oversight, and governance for significant compliance escalations, including alignment on required actions and communications to senior leadership.
• Participate, as needed, in corporate regulatory compliance audits, due diligence, and acquisition compliance assessments; develop strategic plans aligned with enterprise objectives and influence outcomes in a complex, matrixed organization.
• Provide consultative expertise on compliance issue management, including support for Health Authority responses and field action decisions in accordance with policy requirements.
• Provide cGMP training to corporate and internal audit teams on risk-based auditing strategies for key compliance issues and emerging trends.

Qualifications

• A minimum of a bachelor’s degree is required. An advanced degree in an applicable field of study or certification is preferred.
• A minimum of 10 years’ relevant quality and compliance experience is required. Prior work experience in cGMP regulatory compliance in medical device and/or pharmaceutical regulations is required.
• Strong written and oral communication skills that can be adapted to the appropriate levels of a large complex organization to facilitate regulatory compliance risk understanding is required.
• Track record of successful leadership skills in cGMP compliance is required.
• Ability to build productive relationships to work and influence effectively across cultures and functions without line authority is required.
• Ability to work with and effectively influence all levels within the organization is required.
• Self-direction and ability to thrive in a complex matrixed environment is required.
• Up to 20% domestic and international travel may be required as business demands.

Preferred Skills

• Advanced Analytics
• Audit and Compliance Trends
• Audit Findings and Recommendations
• Compliance Management
• Compliance Risk
• Confidentiality
• Controls Compliance
• Developing Others
• Internal Auditing
• Investigation Techniques
• Legal Function
• Mentorship
• Policy Development
• Report Writing
• Tactical Planning
• Technical Credibility