Associate Director, Global Clinical Supply Compliance (Hybrid)

Job Description

The Associate Director in Global Clinical Supply (GCS) Compliance is a subject matter expert and project leader responsible for advancing and sustaining GxP Quality Systems across GCS to ensure clinical supply operations are executed in a compliant, inspection‑ready, and risk‑based manner. GCS supports Phase I–IV trials across 60+ countries in alignment with local and regional regulations for GxP (GMP, GDP, and GCP) and Environmental Health & Safety (EHS).

In this role, the Associate Director applies deep technical judgment and systems level thinking to complex compliance challenges while influencing outcomes across a highly matrixed organization. This role provides expert support and project leadership for key GCS compliance processes —including deviations, CAPA, change control, documentation, training, audits/inspections, analytics, risk management, and EHS. Associate Directors are expected to apply expertise and subject matter depth broadly across these domains.

The Associate Director partners closely with GCS functional areas and stakeholders within Development Sciences and Clinical Supply, our company's Research Laboratories Quality Assurance, Global Development Quality, IT/Digital, GCTO, Procurement, and other enterprise stakeholders to drive compliance strategy, QMS alignment, and performance improvement within GCS.

Qualifications

Education & Experience:

• Bachelor’s degree in a Scientific, Engineering, or related field with 8+ years of relevant experience in a regulated GxP environment; or master’s degree with 6+ years of experience in compliance, quality, technical operations, or related disciplines.

• Demonstrated experience in supporting or managing multiple GxP Quality Systems (e.g., deviations, CAPA, change control, documentation, training, audits/inspections, risk management, EHS) is required.

• Proven ability to lead cross-functional initiatives or complex compliance projects at a regional or global scale.

Skill-based Qualifications:

With strong subject matter expertise, sound judgment, and the ability to lead complex system and process design and execution, candidates must demonstrate:

• Experience and ability to provide technical oversight and strategic process leadership across multiple compliance pillars such as deviations, CAPA, change control, documentation, training, risk management, inspection/audit coordination, and Environmental Health & Safety.

• Proven track record of interpreting regulations and designing new processes or governance frameworks to drive compliance across global network. Includes ability to independently resolve complex compliance challenges and deliver sustainable improvements.

• Advanced ability to apply GxP and ALCOA+ principles to ensure quality and data integrity in system and process execution.

• Expertise in proactively identifying, assessing, and mitigating risks to timelines, scope, compliance outcomes, or deliverables, including high-level escalation and risk communication.

• Proficiency in performing and overseeing complex investigations and CAPA activities with deep root cause identification and QRM-aligned rigor.

• Ability to build and lead strong, trust‑based partnerships across Quality, Supply Chain, Technical Operations, IT, and clinical development stakeholders, enabling collaborative compliance strategies and performance improvement initiatives

• Exceptional analytical skills with demonstrated capability to interpret operational trends and support data‑driven decisions. Includes designing, implementing and optimizing data analytic tools or dashboards for actionable insights.

• Excellent communication skills, supporting clear, concise, and influential interactions across functional and site teams. Includes effective presentations of compliance findings and recommendations to leadership and key stakeholders.

Preferred Experience and Skills:

• Working knowledge of Quality Risk Management (QRM) tools and concepts for application to investigations, change control, and system design.

• Experience contributing to or co‑leading Communities of Practice or SME networks.

• Experience supporting or leading Change Management activities (training, documentation updates, rollout planning).

• Experience with GMP electronic systems (e.g., MEDs, Veeva, TrackWise, LMS, SAP).

• Experience applying Lean Six Sigma or continuous improvement methodologies.

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As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics.  As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.  For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

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The salary range for this role is

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.

The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

We offer a comprehensive package of benefits.  Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.

You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance

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Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. 

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