{"id":3825125,"url":"https://alion.io/job/merck-co-digital-data-quality-director-us","title":"Digital & Data Quality Director - US","company":{"id":3768,"name":"Merck & Co.","domain":"msd.com","url":"https://alion.io/company/msd","size_band":"5000+","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Workday","truth_index":{"grade":"A","score":97,"open_postings":192,"ghost_share":0.031,"stale_share":0.156,"repost_share":0.177,"time_to_fill_p50_days":16,"computed_at":"2026-11-10T06:52:35Z"}},"role":"Leadership","role_family":"Leadership","seniority":"head","employment_type":"full_time","work_mode":"hybrid","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"explicit","locations":["West Point, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":173200,"max":272600,"currency":"USD","period":"year","gross":null,"usd_annual":272600},"salary_estimate":null,"experience_years_min":7,"visa_sponsorship":true,"relocation_package":false,"has_equity":false,"technologies":[{"name":"21 CFR Part 11","optional":false},{"name":"GMP","optional":false}],"status":"live","first_seen_at":"2026-11-05T18:14:19Z","employer_posted_date":"2026-11-05","last_verified_at":"2026-11-10T03:50:29Z","board_verified":true,"closed_at":null,"days_open":4,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":4},"description":"Job Description\nPosition Summary\nThe 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:\nIT applications\nAutomated manufacturing and packaging equipment\nAutomated laboratory systems\nData analysis tools\nEmerging and innovative technologies\nThe DDQ Director is responsible for ensuring compliance with company policies, procedures, and regulatory expectations across assigned areas.\nThis includes oversight of all quality-related activities for:\nComputerized systems supporting site and above-site GMP processes\nSystems required by our Company Manufacturing Division Quality Manual\nSystems with the potential to impact product quality, patient safety, or data integrity\nGMP data controls, both technological and procedural, throughout the data lifecycle\nThe position works closely with stakeholders and management from Quality Operations, Business Units, External Manufacturing, Manufacturing, and Information Technology.\nThe DDQ Director must perform all responsibilities independently, with integrity, fairness, and objectivity to ensure the protection of products and patients.\nKey Responsibilities\nSupport regulatory inspections and audits.\nEffectively and efficiently manage DDQ resources.\nParticipate in the hiring, training, development, and management of DDQ employees.\nCoach and develop direct reports.\nProactively align team and individual goals with regulatory expectations and our Company Manufacturing Division quality objectives.\nModel and reinforce Our Company's leadership behaviors, values, and culture.\nQualifications\nEducation\nBachelor's degree in Science, Information Technology, Engineering, or a related field.\nOR\nMaster'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.\nOR\nPh.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.\nRequired Skills\nExpert 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\nExtensive hands-on experience with the principles, theories, and concepts of computerized system validation and compliance.\nPractical experience implementing quality systems within pharmaceutical, laboratory, biotechnology, or related regulated manufacturing environments.\nPreferred Experience & Skills\nLean Six Sigma, Project Management Professional (PMP), or other relevant professional certifications.\nIn-depth understanding of laboratory, manufacturing, automation, and information systems relevant to the assigned area of oversight.\nExperience leading self-directed teams, setting priorities, and aligning team activities with strategic business objectives.\nCollaborative leadership style focused on listening, coaching, team development, and integrating multiple perspectives.\nThorough understanding of Quality Management Systems for drugs, biologics, medical devices, and risk management.\nStrong business engagement skills, with the ability to collaborate effectively with both technical and non-technical stakeholders.\nDemonstrated expertise in: Negotiation Facilitation Cross-functional relationship building Influencing without direct authority\nExperience leading discussions and interactions during regulatory inspections.\nExcellent verbal and written communication skills.\nStrong analytical problem-solving and root cause analysis capabilities.\nAdaptable and decisive, with the ability to respond effectively to changing business priorities, technologies, and regulatory requirements.\nLeadership Competencies\nDemonstrates integrity, fairness, and objectivity in decision-making.\nEffectively leads teams in a highly regulated environment.\nAligns organizational resources with strategic and regulatory priorities.\nPromotes continuous improvement and operational excellence.\nBuilds strong partnerships across Quality, Manufacturing, Business, and Information Technology organizations.\nDrives compliance, quality, and data integrity throughout the computerized system lifecycle.\nRequired Skills:\nChange 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 ThinkingPreferred Skills:\nCurrent Employees apply HERE\nCurrent Contingent Workers apply HERE\nUS and Puerto Rico Residents Only:\nOur 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.\nAs 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. Asa 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:\nEEOC Know Your Rights\nEEOC GINA Supplement\nWe 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.\nLearn more about your rights, including under California, Colorado and other US State Acts\nThe primary location for this posting is:\nUSA - Pennsylvania - West PointWhere required by law, the compensation range for this role is provided below.\nThe salary range for the primary location of this role is:\n$173,200.00 - $272,600.00This 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.\nWe 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.\nAdditional 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.\nAdditional location(s) Compensation Information:\nSan Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance\nLos 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\nSearch Firm Representatives Please Read Carefully\nMerck & 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.\nEmployee Status:\nRegularRelocation:\nVISA Sponsorship:\nTravel Requirements:\nFlexible Work Arrangements:\nHybridShift:\nValid Driving License:\nHazardous Material(s):\nJob Posting End Date:\n11/19/2026*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. 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