

New · posted Nov 6
Merck · Pharmaceuticals
Digital & Data Quality Director
- West Point, PA
- Hybrid
- Full-time
- Director
The role
The Digital and Data Quality (DDQ) Director will lead the respective DDQ organization and be responsible for the management of all quality aspects of GMP computerized systems utilized by our Company Manufacturing Division, including but not limited to:
- IT applications
- Automated manufacturing and packaging equipment
- Automated laboratory systems
- Data analysis tools
- Emerging and innovative technologies
The DDQ Director is responsible for ensuring compliance with company policies, procedures, and regulatory expectations across assigned areas.
This includes oversight of all quality-related activities for:
- Computerized systems supporting site and above-site GMP processes
- Systems required by our Company Manufacturing Division Quality Manual
- Systems with the potential to impact product quality, patient safety, or data integrity
- GMP data controls, both technological and procedural, throughout the data lifecycle
The position works closely with stakeholders and management from Quality Operations, Business Units, External Manufacturing, Manufacturing, and Information Technology.
The DDQ Director must perform all responsibilities independently, with integrity, fairness, and objectivity to ensure the protection of products and patients.
OR
- Master's degree in Science, Information Technology, Engineering, Business, or a related discipline, with a minimum of twelve (12) years of experience in regulated pharmaceutical manufacturing and delivery of validated enterprise systems.
OR
- Ph.D. in Science, Information Technology, Engineering, Business, or a related discipline, with a minimum of seven (7) years of experience in regulated pharmaceutical manufacturing and delivery of validated enterprise systems.
What you need
Education
- Bachelor's degree in Science, Information Technology, Engineering, or a related field.
Required Skills
- Expert knowledge of relevant regulations and guidance, including: FDA regulations EU regulations ICH guidelines 21 CFR Part 11 21 CFR Parts 210, 211, and 820 EU Annex 11 EU Annex 15 Data Integrity requirements Local regulatory expectations Industry standards such as GAMP
- Extensive hands-on experience with the principles, theories, and concepts of computerized system validation and compliance.
- Practical experience implementing quality systems within pharmaceutical, laboratory, biotechnology, or related regulated manufacturing environments.
Required Skills
Change Management, Coaching, Data Integrity, Decision Making, Interpersonal Relationships, Manufacturing Quality Control, Operational Efficiency, People Leadership, Quality Auditing, Quality Management Standards, Quality Risk Management, Regulatory Compliance, Results-Oriented, Risk Management, Strategic Thinking
Preferred Experience & Skillsnice to have
- Lean Six Sigma, Project Management Professional (PMP), or other relevant professional certifications.
- In-depth understanding of laboratory, manufacturing, automation, and information systems relevant to the assigned area of oversight.
- Experience leading self-directed teams, setting priorities, and aligning team activities with strategic business objectives.
- Collaborative leadership style focused on listening, coaching, team development, and integrating multiple perspectives.
- Thorough understanding of Quality Management Systems for drugs, biologics, medical devices, and risk management.
- Strong business engagement skills, with the ability to collaborate effectively with both technical and non-technical stakeholders.
- Demonstrated expertise in: Negotiation Facilitation Cross-functional relationship building Influencing without direct authority
- Experience leading discussions and interactions during regulatory inspections.
- Excellent verbal and written communication skills.
- Strong analytical problem-solving and root cause analysis capabilities.
- Adaptable and decisive, with the ability to respond effectively to changing business priorities, technologies, and regulatory requirements.
Leadership Competencies
- Demonstrates integrity, fairness, and objectivity in decision-making.
- Effectively leads teams in a highly regulated environment.
- Aligns organizational resources with strategic and regulatory priorities.
- Promotes continuous improvement and operational excellence.
- Builds strong partnerships across Quality, Manufacturing, Business, and Information Technology organizations.
- Drives compliance, quality, and data integrity throughout the computerized system lifecycle.
What you'll do
- Support regulatory inspections and audits.
- Effectively and efficiently manage DDQ resources.
- Participate in the hiring, training, development, and management of DDQ employees.
- Coach and develop direct reports.
- Proactively align team and individual goals with regulatory expectations and our Company Manufacturing Division quality objectives.
- Model and reinforce Our Company's leadership behaviors, values, and culture.
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 and compassionate days
Annual bonus and long-term incentive
Where you'll work
West Point, PAHybridOpen in Maps (opens in a new tab)
More jobs in West Point, PAWorking conditions
Employee Status
Regular
Flexible Work Arrangements
Hybrid
Job Posting End Date
11/19/2026
*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.
Learn more about your rights, including under California, Colorado and other US State Acts
The primary location for this posting is:
USA - Pennsylvania - West Point
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 4% below the US median for Software Quality & CSV roles at this level.
This roleEmployer provided
Director roles in the US7 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $173,000 | — | $273,000 |
| All US (middle half) | $221,250 | $231,500 | $238,250 |
This role: Merck's own published range. Comparisons: the base pay employers published on open Software Quality & CSV roles at the same level on Regulatory Jobs, November 6, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Software Quality & CSV
The general path across 55 open Software Quality & CSV 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 46 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Collaboration and leadership13
- GMP and compliance10
- Data and digital systems7
- Lab testing and methods4
- Quality systems and risk4
- Validation and qualification3
- Documentation and SOPs2
- Investigations and CAPA1
Regulatory intelligence
The rules, regulations and standards behind this role
The regulations, guidance and standards that govern Software Quality & CSV work in pharmaceuticals, led by the six this posting names, each linked to the agency or standards body that publishes it.
- FDA21 CFR Part 11(official source, opens in a new tab)FDA rules for electronic records and electronic signaturesNamed 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
- FDAFDA data integrity guidance(official source, opens in a new tab)Data Integrity and Compliance With Drug CGMP: Questions and AnswersNamed in the posting
- FDA21 CFR Parts 210 and 211(official source, opens in a new tab)FDA current good manufacturing practice for finished pharmaceuticalsNamed 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
- ICHICH Q9(R1)(official source, opens in a new tab)Quality risk managementNamed in the posting
- ICHICH Q10(official source, opens in a new tab)The pharmaceutical quality system across the product lifecycle
- 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
- ASTMASTM E2500(official source, opens in a new tab)Specification, design and verification of pharmaceutical manufacturing systems and equipment
- FDA21 CFR Part 58 (GLP)(official source, opens in a new tab)Good laboratory practice for nonclinical laboratory studies
- ICHICH E6(R3) good clinical practice(official source, opens in a new tab)The international standard for the design, conduct and reporting of clinical trials
- FDAFDA study data standards(official source, opens in a new tab)Required data standards and technical conformance for clinical study data
- EUGDPR (Regulation 2016/679)(official source, opens in a new tab)The EU General Data Protection Regulation for personal data, including health data
- HHSHIPAA Privacy Rule(official source, opens in a new tab)Federal protections for individually identifiable health information
- 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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Digital & Data Quality Director at Merck
Applications close November 19. $173K–$273K a year, employer provided.


