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, owning and executing core compliance programs for Regulatory Standards Management, Inspection Support, and JJT-TS Inspection Readiness. This role partners with JJT-TS, EQ, and business segments to ensure compliance with J&J Quality Standards and global regulatory requirements, integrates new regulations into QMS and operational processes, and oversees the Inspection Readiness program and related activities.

Responsibilities

• Compliance Programs Ownership ‚Äì Standards Management, Inspection Support and JJT-TS Inspection Readiness (50%)
• Owns the Regulatory Standards Management program for Enterprise Quality; lead gap assessments, monitor implementation status, document meeting minutes, and manage gaps/remediation.
• Partner with TRC Operations for schedules/resourcing; secure alignment for audit/remediation actions across groups.
• Provide compliance SME inputs to TRC risk assessment; ensure technology risk factors are incorporated.
• Lead Technology Services Health Authority inspection readiness program; prepare procedures, data center/site readiness, SME preparation, and regulatory engagement as needed.
• Manage Health Authority inspection support across segments; expand program to cover new areas (e.g., medical device software, digital health).
• Support global J&J operating companies with inspection requests and regulatory interactions; prepare SMEs for regulator conversations.
• Interpret and evaluate risk from inspection findings; contribute to formal responses to health authority observations.
• Develop and deliver education and training on inspection processes and lessons learned; lead communication for inspection engagement.
• Provide education/training on compliance requirements, procedures, and controls as applicable.

• Compliance Program Management ‚Äì (20%)
• Lead TRC PMO and multi-year technology compliance roadmap; drive process digitalization, program evolution, talent development, and knowledge management.
• Ow n central ownership of compliance program procedures/templates (internal audits, supplier audits, periodic reviews); drive simplification and alignment with regulatory direction.
• Strategize adoption of digital solutions; manage TRC audit management systems lifecycle and new features.
• Maintain knowledge of TRC initiatives; advise Head of TRC on strategic/operational matters.
• Align TRC planning with JJRC, EQ, and JJT-Technology Services strategies; foster knowledge-sharing and talent development.
• Develop talent pipelines and internal/external candidate identification for TRC roles.

• External Advocacy (20%)
• Monitor external regulatory environment for new/regulatory requirements and enforcement trends related to IT systems, data integrity, and health tech (SAMD, AI/ML, RPA).
• Maintain knowledge of Health Authority regulations impacting computerized systems across functions; guide regulatory outreach strategy.
• Lead regulatory outreach direction with JJRC-Enterprise Regulatory Outreach; align with business priorities.
• Engage with regulators and external organizations when requested; interpret and communicate regulations globally; raise awareness within TRC, EQ, and JJRC.
• Participate in industry networks to stay current on standards and best practices; engage with groups (ISPE, AdvaMed).

• Stakeholder Management, Compliance Expertise and Support for Innovation Initiatives (10%)
• Partner with cross-functional leaders on TRC processes, capabilities, and initiatives; manage relationship plan with stakeholders.
• Assess, develop, and implement solutions enabling compliant innovation; identify risks and mitigation strategies.
• Serve as SME to JJT-TS, EQ, and JJRC Segment Leaders for innovative technology initiatives.
• Collaborate to perform gap assessments against new regulatory expectations; define corrective actions with Quality partners.
• Assist stakeholders in drafting comments on proposed regulations and guidance.

Qualifications

Education

A minimum of a Bachelor's degree is required with a focus in science, IT, engineering, business, or QRC discipline is highly preferred.

Required

• 7+ years of experience in managing all aspects of Quality and Regulatory Compliance in an international, regulated healthcare environment.
• Minimum of 2 years of experience in information systems auditing within Pharmaceutical/Medical Device company or 3 years of direct experience with development/implementation/validation of computerized systems in such a company.
• Expert knowledge of Quality System regulations (ISO, ICH, PIC/S, cGMP), including Annex 11, 21 CFR Part 11, Part 210, Part 211, Part 820, and applicability to Computer Systems.
• Expert knowledge of IT internal controls, SDLC methodologies, GAMP5, and data integrity requirements.
• Experience supporting health authority inspection activities; ability to translate regulations into practical strategies.
• Strong analytical and communication skills; ability to present complex topics clearly; independent work style; ability to lead cross-functional teams.
• Acknowledged ability to influence, negotiate, and build credibility; strong partnering skills.
• 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, and digital health technologies.
• Understanding of medical device software quality requirements and related risk management.
• Data analysis and reporting; risk-based audit framework development and execution; audit logistics coordination.

Additional Requirements

• This position may require up to 20% domestic and international travel.