Associate Director, Global Clinical Supply Compliance (Hybrid)
Merck
June 25, 2026
Remote friendly (Rahway, NJ)
United States
Operations
Associate Director, Global Clinical Supply (GCS) Compliance
Responsibilities
- Lead and sustain GxP Quality Systems across GCS to ensure clinical supply operations are compliant, inspection-ready, and risk-based.
- Provide expert support and project leadership for GCS compliance processes: deviations, CAPA, change control, documentation, training, audits/inspections, analytics, risk management, and EHS.
- Apply technical judgment and systems-level thinking to complex compliance challenges; influence outcomes across a highly matrixed organization.
- Partner with GCS and enterprise stakeholders to drive compliance strategy, QMS alignment, and performance improvement.
Qualifications
- Bachelor’s degree in a Scientific/Engineering/related field with 8+ years in a regulated GxP environment, or Master’s degree with 6+ years in compliance/quality/technical operations or related disciplines.
- Demonstrated experience supporting/managing multiple GxP Quality Systems (deviations, CAPA, change control, documentation, training, audits/inspections, risk management, EHS).
- Proven ability to lead cross-functional initiatives or complex compliance projects at regional/global scale.
Skills (required)
- Technical oversight across compliance pillars (deviations, CAPA, change control, documentation, training, risk management, inspection/audit coordination, EHS).
- Interpret regulations; design processes/governance frameworks for global compliance.
- Apply GxP and ALCOA+ for quality and data integrity.
- Identify, assess, mitigate risks and communicate/escalate as needed.
- Lead complex investigations and CAPA with deep root cause identification and QRM-aligned rigor.
- Build trust-based partnerships across Quality, Supply Chain, Technical Operations, IT, and clinical development.
- Advanced analytical skills; develop dashboards/analytics for actionable insights.
- Clear, influential communication; present compliance findings/recommendations to leadership.
Preferred Skills
- QRM tool/concept knowledge; communities of practice/SME network involvement.
- Change management experience (training, documentation updates, rollout planning).
- GMP electronic systems exposure (e.g., MEDs, Veeva, TrackWise, LMS, SAP).
- Lean Six Sigma/continuous improvement experience.
Responsibilities
- Lead and sustain GxP Quality Systems across GCS to ensure clinical supply operations are compliant, inspection-ready, and risk-based.
- Provide expert support and project leadership for GCS compliance processes: deviations, CAPA, change control, documentation, training, audits/inspections, analytics, risk management, and EHS.
- Apply technical judgment and systems-level thinking to complex compliance challenges; influence outcomes across a highly matrixed organization.
- Partner with GCS and enterprise stakeholders to drive compliance strategy, QMS alignment, and performance improvement.
Qualifications
- Bachelor’s degree in a Scientific/Engineering/related field with 8+ years in a regulated GxP environment, or Master’s degree with 6+ years in compliance/quality/technical operations or related disciplines.
- Demonstrated experience supporting/managing multiple GxP Quality Systems (deviations, CAPA, change control, documentation, training, audits/inspections, risk management, EHS).
- Proven ability to lead cross-functional initiatives or complex compliance projects at regional/global scale.
Skills (required)
- Technical oversight across compliance pillars (deviations, CAPA, change control, documentation, training, risk management, inspection/audit coordination, EHS).
- Interpret regulations; design processes/governance frameworks for global compliance.
- Apply GxP and ALCOA+ for quality and data integrity.
- Identify, assess, mitigate risks and communicate/escalate as needed.
- Lead complex investigations and CAPA with deep root cause identification and QRM-aligned rigor.
- Build trust-based partnerships across Quality, Supply Chain, Technical Operations, IT, and clinical development.
- Advanced analytical skills; develop dashboards/analytics for actionable insights.
- Clear, influential communication; present compliance findings/recommendations to leadership.
Preferred Skills
- QRM tool/concept knowledge; communities of practice/SME network involvement.
- Change management experience (training, documentation updates, rollout planning).
- GMP electronic systems exposure (e.g., MEDs, Veeva, TrackWise, LMS, SAP).
- Lean Six Sigma/continuous improvement experience.