Digital & Data Quality Director - US

Job Description

Position Summary

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.

Key Responsibilities

• 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.

Qualifications

Education

• Bachelor's degree in Science, Information Technology, Engineering, or a related field.

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.

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.

Preferred Experience & Skills

• 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.

Required Skills:

Preferred Skills:

Current Employees apply HERE

Current Contingent Workers apply HERE

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. 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:

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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.

Learn more about your rights, including under California, Colorado and other US State Acts

The primary location for this posting is:

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

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

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

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.

Employee Status:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

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Hazardous Material(s):

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