Key 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.
• Review US FDA response reviews, as assigned, to ensure completeness, quality, and alignment with applicable requirements.
• Analyze large volumes of regulatory compliance data to identify actionable insights and lead periodic data driven compliance reviews for senior executive leadership.
• Actively build and maintain AI literacy and fluency, and apply approved AI enabled tools to improve individual and team ways of working (e.g., analysis, synthesis, documentation, and quality checks), in alignment with data governance, privacy, and responsible AI expectations.
• 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.

The Director, Enterprise Regulatory Compliance is a highly visible role within the Quality and Compliance organization and requires expert global regulatory compliance knowledge and practical expertise across pharmaceuticals and medical devices.

Qualifications

• A minimum of a bachelor’s degree is required.
• Advanced degree in an applicable field of study or certification is preferred.
• A minimum of 10 years’ relevant quality and compliance experience is required.
• Work experience for a Health Authority or Notified Body is preferred but not 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.

Required Skills

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, Legal Services, Mentorship, Policy Development, Report Writing, Tactical Planning, Technical Credibility