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

1000 Merck Sharp & Dohme LLC; Wilmington (DE); Hybrid; USD 173,000 - 273,000; Full time

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Healthcare

Retirement Benefits

401(k)

Paid Holidays

Vacation

Sick Days

Job summary

MSD is seeking an experienced Director– Quality Management Systems (QMS) & Digital Quality Governance to lead the QMS workstream within a global laboratory transformation program. You will architect and deploy a modern digital QMS integrated with LIMS/ELN and automated workflows, ensuring compliance and efficiency across global operations.

You will direct strategy for deviation management, investigations, CAPA, change control, and validation, while embedding data integrity and CSA principles.

Qualifications

• Experience designing and overseeing enterprise-level QMS in cgmp laboratories.
• Strong knowledge of Data Integrity expectations and regulatory requirements (21 CFR Part 11/EU Annex 11).
• Experience with inspections by global health authorities (FDA/EMA/PMDA) and regulatory dossiers.

Responsibilities

• Define, lead, and execute QMS integration strategy for the lab transformation program.
• Oversee eQMS; review and understand underlying code for compliance.
• Embed Data Integrity by Design (ALCOA+) and CSA into digitized laboratory platforms.
• Ensure QMS processes comply with global cGMP regulations and SOPs; drive inspection readiness.
• Direct QMS governance, track milestones, risks, and interdependencies; reporting to executives.
• Drive change management and training to enable digitized QA workflows across sites.
• Collaborate across operations, technology, regulatory affairs, and validation teams.
• Mentor quality specialists and oversee external vendors in regulated environments.

Skills

Analytical Development

Cross-Functional Leadership

Digital Transformation

Enterprise Transformation

Executive Communications

GMP Compliance

Laboratory Quality Control

Project Governance

Quality Management Systems

Regulatory Strategies

Education

Bachelor’s degree in a related science field

Advanced degree preferred (Master’s, PhD, PharmD, or MBA)

Tools

LIMS

ELN

CDS

SDMS

TrackWise

Veeva Vault QMS

Job description

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

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, 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

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. 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: EEOC Know Your Rights EEOC GINA Supplement 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.

Salary

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.

Additional Location(s)

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.

Benefits

• Medical
• Dental
• Vision Healthcare
• Other Insurance Benefits (for employee and family)
• Retirement Benefits
• 401(k)
• Paid Holidays
• Vacation
• Compassionate and Sick Days

We offer a comprehensive package of benefits. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.

Employee Status

Regular

Relocation

No relocation

VISA Sponsorship

No

Travel Requirements

10%

Flexible Work Arrangements

Hybrid

Job Posting End Date

12/3/2026

Search Firm Representatives

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.

Company Overview

Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where we have codified our legacy for over a century. Our success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.