Associate Director, Centralized Compliance Services

Role Summary

The Associate Director, Centralized Compliance Services leads centralized services, capabilities, and strategies supporting Technology Regulatory Compliance (TRC) functional effectiveness. Responsible for ownership, management, and execution of core compliance programs for Regulatory Standards Management, Inspection Support, and JJT-TS Inspection Readiness, across J&J Technology Services and Enterprise Quality, with oversight of risk assessment inputs, regulatory integration, and external outreach.

Responsibilities

• Compliance Programs Ownership ‚Äì Standards Management, Inspection Support and JJT-TS Inspection Readiness (50%)
• Owns the Regulatory Standards Management program for Enterprise Quality, coordinates gap assessments, integrates changes into business processes, and documents outcomes; facilitates Standards Council meetings and manages escalation for remediation.
• Collaborates with TRC Operations for schedules and resourcing; negotiates alignment for audit and remediation actions; provides risk assessment inputs for TRC.
• Leads Technology Services Health Authority inspection readiness program, including procedures, site readiness, SME preparation, and regulator engagement as needed.
• Manages Health Authority inspection support across segments; ensures expansion to emerging areas such as medical device software and digital health; supports global operating companies and prepares SMEs for investigators.
• Interprets inspection findings, provides direction on remediation, and reviews formal responses to health authority observations.
• Develops and delivers education and training on inspection processes and lessons learned; leads communication for inspection engagement.
• Leads or supports education on compliance requirements and controls as applicable.

• Compliance Program Management ‚Äì (20%)
• Leads TRC PMO and multi-year technology compliance roadmap; manages digitalization, automation, talent development, and knowledge management.
• Owning compliance program procedures/templates (internal audits, supplier audits, periodic reviews); drives simplification and alignment with regulatory direction.
• Guides adoption of digital solutions, lifecycle management of TRC audit systems, and deployment of new features.
• Maintains knowledge of TRC strategic initiatives; advises Head of TRC on strategic/operational matters; aligns TRC plans with JJRC/EQ/TS strategies.
• Fosters knowledge sharing and talent development; organizes training and regulatory guidance debriefs; supports succession and development goals.
• Leads talent pipeline for compliance and technology roles.

• External Advocacy (20%)
• Monitors external regulatory environment; tracks enforcement trends related to IT systems, data integrity, and Health Tech areas (SAMD, AI/ML, RPA); stays current with regulations affecting computerized systems.
• Maintains strong regulatory knowledge; guides regulatory outreach directions; engages with third parties and external bodies as needed.
• Interprets and communicates regulations globally; raises awareness of regulatory developments within TRC, EQ, and JJRC; participates in industry networks to influence external environment.

• Stakeholder Management, Compliance Expertise and Support for Innovation Initiatives (10%)
• Provides partnership and guidance to cross-functional leaders on TRC processes and initiatives; maintains stakeholder relationships and alignment with EQ leads.
• Collaborates to assess and implement compliant innovation; identifies risks and drives proactive mitigation; serves as SME to JJT-TS, EQ, and JJRC leads on technology initiatives.
• Works with Technology Services, Enterprise Quality, and Business Quality to bridge gaps between current practices and regulatory expectations, and develops comments on proposed regulations.

Qualifications

Education

• A minimum of a Bachelors or University degree required, with focus in science, IT, engineering, business, or QRC discipline preferred.

• Required
• 7+ years of experience in managing Quality and Regulatory Compliance in an international, regulated healthcare environment.
• Minimum 2 years of experience in information systems auditing within pharmaceutical/medical device company, or 3 years of direct experience with development/validation of computerized systems in such companies.
• Expert knowledge of Quality System regulations (ISO, ICH, PIC/S, cGMP) including Annex 11, 21 CFR Part 11, Part 210, Part 211, Part 820; application to Computer Systems.
• Expert knowledge of IT internal controls, SDLC, GAMP5, data integrity requirements.
• Experience supporting health authority inspections; translating regulations into practical strategies.
• Ability to resolve complex regulatory issues; strong analytical and interpretive skills for journals and legal documents.
• Proven strategy development, excellent written and oral communication, independent work, and capability to present to executives.
• Strong leadership, cross-functional collaboration, negotiation, and credibility-building abilities.
• Audit management and delivery, up-to-date compliance knowledge, stakeholder coordination.
• Analytical mindset.

• Preferred
• Advanced auditing skills with aptitude for auditing Information Systems and related processes.
• Interest in Industry 4.0, Quality 4.0, digital health; understanding of medical device software quality requirements and risk management.
• Data analysis and reporting; risk-based audit framework development and execution; audit logistics coordination.

Other

• Up to 20% domestic and international travel may be required.