Director, Global Clinical Supply Compliance (Hybrid)

Job Description

The Director in Global Clinical Supply (GCS) Compliance is a technical leader responsible for governing and advancing GCS’s global GxP Quality Systems to ensure the organization executes clinical supply operations 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.

This role provides global‑level oversight and strategic direction across key GCS compliance processes—including deviations, CAPA, change control, documentation, training, audits/inspections, analytics, risk management, and safety—while recognizing that individual depth may vary by area. Directors are expected to lead broadly across these domains and apply deeper expertise where their strengths align.

The Director partners closely with GCS functional areas and stakeholders within Development Sciences and Clinical Supply, our Research & Development Division 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 10+ years of relevant experience in a regulated GxP environment; or master’s degree with 8+ years of experience in compliance, quality, technical operations, or related disciplines.

• Experience leading or governing multiple GxP Quality Systems (e.g., deviations, CAPA, change control, documentation, training, audits/inspections, risk management, safety) is required.

• Demonstrated experience influencing cross-functional teams across global or multi-site organizations.

Skill-based Qualifications:

With strong independent judgment, advanced technical expertise, and the ability to lead enterprise-wide compliance systems, candidates must demonstrate:

• Ability to provide strategic oversight and governance for GxP processes across deviations, CAPA, change control, documentation, training, risk management, and safety.

• Deep understanding of GxP and ALCOA+ principles with the ability to embed quality and data integrity expectations into system and process design.

• Ability to identify, assess, and mitigate risks to issue resolution, timelines, scope, compliance outcomes, or deliverables, and to escalate appropriately.

• Ability to build and strengthen trust-based, collaborative relationships across diverse stakeholders, including global Quality, Supply Chain, Technical Ops, IT, and clinical development organizations.

• Strong strategic thinking and decision-making, with the ability to interpret data, assess trends, and drive systemic improvements.

• Excellent communication skills, with the ability to convey complex information clearly, persuasively, and tactfully across all organizational levels.

• Ability to lead global investigations and CAPA governance, ensuring strong root cause analysis and effectiveness evaluation aligned with QRM expectations.

Preferred Experience and Skills:

• Quality Risk Management (QRM) expertise for application to investigations, change control, and system design.

• Leadership of Communities of Practice or global SME networks supporting system governance.

• Data and analytics proficiency (KPI development, trending, dashboards).

• Formal Change Management training or demonstrated skill in leading cross‑functional change.

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

• Lean Six Sigma experience or equivalent continuous improvement capability.

Required Skills:

Adaptability, Clinical Trials Operations, Collaborative Development, Compliance Strategies, Cross-Functional Leadership, Decision Making, Documentations, GMP Compliance, Leadership, Performance Monitoring, Process Improvements, Project Governance, Project Planning, Regulatory Compliance, Resource Allocation, Results-Oriented, Risk Management, Safety Management, Strategic Planning, Strategic Thinking, Technical Quality Assurance, Time Management

Preferred Skills:

Change Management, Continuous Improvement, Quality Management Systems (QMS), Standard Operating Procedure (SOP) Review

Current Employees apply HERE

Current Contingent Workers apply HERE

US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.

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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We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.

Learn more about your rights, including under California, Colorado and other US State Acts

U.S. Hybrid Work Model

Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.

The salary range for this role is

$173,200.00 - $272,600.00

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

Search Firm Representatives Please Read Carefully 
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. 

Employee Status:

Regular

Relocation:

No relocation

VISA Sponsorship:

No

Travel Requirements:

10%

Flexible Work Arrangements:

Hybrid

Shift:

1st - Day

Valid Driving License:

No

Hazardous Material(s):

n/a

Job Posting End Date:

04/14/2026

*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.