New · posted Nov 6
Merck · Pharmaceuticals
Director– Quality Management Systems (QMS) & Digital Quality Governance
- Wilmington, DE +2 more
- Hybrid
- Full-time
- Director
The role
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.
What you need
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.
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
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.
Travel Requirements
10%
Preferred Experiencenice to have
- 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.
Pay and benefits
$173,000 – $273,000 a year
Employer providedAdditional 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
Medical, dental and vision insurance
401(k) retirement benefits
Paid holidays
Vacation
Sick days
Annual bonus and long-term incentive
Where you'll work
Wilmington, DE +2 moreHybridOpen in Maps (opens in a new tab)
Also posted for: Rahway, NJ · West Point, PA
More jobs in Wilmington, DE +2 moreWorking conditions
Not Indicated
Hazardous Material(s)
n/a
Employee Status
Regular
Relocation
No relocation
VISA Sponsorship
No
Flexible Work Arrangements
Hybrid
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.
Equal opportunity, accessibility and legal noticesMerck's statements, word for word
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:
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.
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.
Job intelligence
The context around this role
Live data · November 6, 2026
Salary intelligence
How the pay compares
This role's midpoint is 13% above the US median for Quality Systems & Document Control roles at this level.
This roleEmployer provided
Director roles in the US9 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $173,000 | — | $273,000 |
| All US (middle half) | $186,000 | $196,500 | $223,000 |
This role: Merck's own published range. Comparisons: the base pay employers published on open Quality Systems & Document Control roles at the same level on Regulatory Jobs, November 6, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Quality Systems & Document Control
The general path across 84 open Quality Systems & Document Control roles on Regulatory Jobs, with the titles they carry most. Not Merck's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 31 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Lab testing and methods17
- Quality systems and risk15
- GMP and compliance11
- Collaboration and leadership11
- Data and digital systems7
- Validation and qualification4
- Investigations and CAPA3
- Regulatory submissions3
- Documentation and SOPs2
Regulatory intelligence
The rules, regulations and standards behind this role
The regulations, guidance and standards that govern Quality Systems & Document Control work in pharmaceuticals, led by the ten this posting names, each linked to the agency or standards body that publishes it.
- FDA21 CFR Parts 210 and 211(official source, opens in a new tab)FDA current good manufacturing practice for finished pharmaceuticalsNamed in the posting
- ICHICH Q10(official source, opens in a new tab)The pharmaceutical quality system across the product lifecycleNamed in the posting
- FDA21 CFR Part 11(official source, opens in a new tab)FDA rules for electronic records and electronic signaturesNamed in the posting
- FDAFDA data integrity guidance(official source, opens in a new tab)Data Integrity and Compliance With Drug CGMP: Questions and AnswersNamed in the posting
- ICHICH Q9(R1)(official source, opens in a new tab)Quality risk managementNamed in the posting
- EUEU GMP (EudraLex Volume 4)(official source, opens in a new tab)The EU's good manufacturing practice rules, including Annex 1 sterile and Annex 15 validationNamed in the posting
- ISPEISPE GAMP 5(official source, opens in a new tab)A risk-based approach to compliant GxP computerized systemsNamed in the posting
- FDA21 CFR Part 314(official source, opens in a new tab)Applications for FDA approval to market a new drug (NDA and ANDA)Named in the posting
- FDAFDA OOS guidance(official source, opens in a new tab)Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical ProductionNamed in the posting
- PMDAJapan PMDA(official source, opens in a new tab)Japan's Pharmaceuticals and Medical Devices AgencyNamed in the posting
- FDA21 CFR 314.70(official source, opens in a new tab)Supplements and other changes to an approved application (post-approval CMC changes)
- FDAFDA Investigations Operations Manual(official source, opens in a new tab)How FDA investigators plan and conduct inspections
- ISOISO 19011(official source, opens in a new tab)Guidelines for auditing management systems
- FDAFDA quality agreements guidance(official source, opens in a new tab)Contract Manufacturing Arrangements for Drugs: Quality Agreements
- FDA21 CFR Part 7(official source, opens in a new tab)FDA enforcement policy, including product recalls
- PIC/SPIC/S(official source, opens in a new tab)The Pharmaceutical Inspection Co-operation Scheme and its GMP guide
Company hiring pulse
Merck on Regulatory Jobs
- 45
- Open roles
- 45
- Distinct roles
- 8
- Locations
By discipline
- Clinical28 62%
- Quality10 22%
- Regulatory7 16%
By level
- Director34 76%
- Associate & Specialist6 13%
- Senior & Principal4 9%
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Director– Quality Management Systems (QMS) & Digital Quality Governance at Merck
Applications close December 3. $173K–$273K a year, employer provided.