Director– Quality Management Systems (QMS) & Digital Quality Governance

Job Description

Position Overview

Quality Lead, Director– QMS & Digital Quality Governance Analytical

Global Quality Management Systems

 

The Global Quality Group within our Company Manufacturing Division is seeking an experienced transformation lead in the capacity of Director– Quality Management Systems (QMS) & Digital Quality Governance, to provide strategic and operational leadership for the QMS workstream within a complex, enterprise-level laboratory transformation program.

 

This role is accountable for architecting, modernizing, and deploying a modernized, digitized Quality Management System tailored to support next-generation QC testing, end-to-end analytical digitization, instrumentation innovation, and laboratory automation.

 

The QMS Quality Lead will oversee the harmonization and evolution of quality processes—including deviation management, investigations, CAPA, change control, risk management (ICH Q9), and computerized systems validation (CSV/CSA)—to ensure seamless integration with modern automated laboratory workflows, LIMS, ELN, and digital data pipelines. In close partnership with the program leadership team, Site Quality heads, Analytical Development, Digital/IT Quality, and Regulatory Compliance, the incumbent will ensure that innovative operational models maintain rigorous compliance with global health authority regulations while driving efficiency, inspection readiness, and continuous improvement.

Key Responsibilities and Requirements

The ideal candidate will combine deep technical expertise in global Quality Management Systems with a forward-thinking innovation mindset, translating digital and automated laboratory advancements into agile, compliant, and sustainable QMS frameworks.

• Strategic QMS Architecture & Modernization: Define, lead, and execute the QMS integration strategy for the lab transformation initiative, ensuring core quality processes (Change Control, OOS/OOE/OOT investigations, Deviations, CAPA, Method Transfer/Validation, and Batch Release support) are optimized, digitized, and natively integrated with automated laboratory systems
• Coding Experience:  Experience and understanding on how coding translates to QMS and analytical functions.   Responsible for overseeing the eQMS  and ability to be able to review and understand the underlying code and how it is ensures compliance.
• Digital Quality & Data Integrity Governance: Partner with IT/Digital Quality and Automation engineers to embed robust Data Integrity by Design (ALCOA+) and Computer Software Assurance (CSA) principles into digitized laboratory platforms, instrument interfaces, and automated data flows.
• Regulatory Compliance & Inspection Readiness: Ensure all modernized QMS processes, policies, and standard operating procedures (SOPs) comply with global cGMP regulations (FDA 21 CFR Part 11/210/211, EU Annex 11, ICH Q9/Q10, WHO). Drive inspection readiness strategies and author/review corresponding regulatory briefing documents and filing sections.
• Matrixed Program Leadership & Governance: Direct the QMS workstream governance forum, actively tracking milestone execution, interdependencies, risks, and critical paths. Provide regular data-driven progress updates, risk assessments, and escalation pathways to the Overall Quality Lead and executive steering bodies.
• Change Management & Operational Transition: Drive human-centered change management and training initiatives to support site-level and global QC laboratory adoption of digitized quality workflows, fostering a strong culture of quality and transformation agent mindset.
• Cross-Functional Collaboration: Serve as the central quality authority across laboratory operations, technology development, computerized systems validation, and regulatory affairs, eliminating silos and resolving complex compliance roadblocks.
• People Leadership & Oversight: Supervise and mentor quality specialists, compliance leads, and external consultants supporting QMS transformation, maintaining high standards of technical rigor, accountability, and development.

 

Required Experience

• Education: Bachelor’s degree in Chemistry, Biochemistry, Pharmacy, Engineering, Life Sciences, or related discipline required; advanced degree (Master’s, PhD, PharmD, or MBA) strongly preferred.
• Experience: 10+ to 15+ years of progressive experience in pharmaceutical/biopharmaceutical quality operations, quality systems, or compliance within a cGMP manufacturing and QC laboratory environment.
• Quality Systems Expertise: Proven track record in designing, optimizing, and overseeing enterprise-level QMS processes (Deviations, Investigations, CAPA, Change Control, Out of Specification, and Quality Risk Management) in laboratories subject to global health authority inspections (e.g., FDA, EMA, PMDA).
• Digital & Laboratory Systems Acumen: In-depth knowledge of laboratory digital ecosystems, including LIMS, ELN, CDS, SDMS, automated instrumentation, and their integration into enterprise QMS platforms (e.g., TrackWise, Veeva Vault QMS).
• Validation & Compliance Mastery: Strong understanding of Data Integrity expectations, 21 CFR Part 11, EU Annex 11, and modern risk-based validation methodologies (GAMP 5, Computer Software Assurance).
• Governance & Program Execution: Demonstrated success leading large-scale cross-functional workstreams, setting project milestones, proactively managing risk registers, and driving accountable execution.
• Communication & Influencing: Exceptional written and verbal communication skills, with proven ability to present technical compliance strategies effectively to executive sponsors, auditors, and technical teams.

 

Preferred Experience

• Direct experience leading or supporting QMS transformation initiatives (e.g., transition from paper/hybrid to end-to-end digitized paperless QC environments).
• Working knowledge of automated testing platforms, robotics, or continuous manufacturing/testing control frameworks.
• Experience with global health authority inspections, pre-approval inspections (PAIs), and authoring QMS/Quality sections for regulatory dossiers (NDA, BLA, MAA).
• Practical application of Lean / Six Sigma methodologies to streamline quality workflows and cycle times.
• Programming experience is an asset, and or strong demonstrated ability to quickly learn.
• Experience supporting enterprise workforce strategy, technology evaluation, or transition initiatives.
• Experience managing external third party service providers, software vendors, and implementation partners in regulated environments.

 

Required Skills:

Analytical Development, Cross-Functional Leadership, Digital Transformation, Enterprise Transformation, Executive Communications, GMP Compliance, Laboratory Quality Control, Project Governance, Quality Management Systems (QMS), Regulatory Strategies

Preferred Skills:

Analytical Testing, Change Leadership, Program Governance

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US and Puerto Rico Residents Only:

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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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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.

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The primary location for this posting is:

USA - Delaware - Wilmington (Biotech)

Where required by law, the compensation range for this role is provided below.

The salary range for the primary location of this role is:

$173,200.00 - $272,600.00

This range reflects the Company's reasonable expectation of the base salary applicable to this role at the time of 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.

Additional location(s): Please note the salary range above applies to the Primary Location of the position. Where a role has other listed locations, different compensation guidelines may apply. You may find the salary ranges for additional locations below. If the salary range is not listed for the location you are applying to, our Talent Acquisition team will provide further information to you relevant to your location.

Additional location(s) Compensation Information:

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. 

Employee Status:

Regular

Relocation:

No relocation

VISA Sponsorship:

No

Travel Requirements:

10%

Flexible Work Arrangements:

Hybrid

Shift:

Not Indicated

Valid Driving License:

No

Hazardous Material(s):

n/a

Job Posting End Date:

12/3/2026

*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.