Digital & Data Quality Director - US

Merck & Co.; West Point (PA); Ibrido; USD 173.000 - 273.000; Tempo pieno

Vantaggi offerti da questo lavoro

Hybrid work arrangements

Annual bonus and long-term incentive

Comprehensive benefits package

Descrizione del lavoro

Merck & Co. is seeking a Director of Digital and Data Quality to lead the DDQ organization and oversee quality for GMP computerized systems across Company Manufacturing Division.

The role ensures compliance with policies and regulatory expectations, including systems impacting product quality and data integrity. You will collaborate with Quality Operations, Business Units, External Manufacturing, and IT, guiding a team in a highly regulated environment and driving continuous improvement in data

Competenze

• Strong knowledge of FDA/ICH/GAMP requirements and data integrity.
• Extensive experience validating GMP computerized systems and related quality processes.
• Proven ability to lead quality governance for regulated pharma systems.

Mansioni

• Support regulatory inspections and audits.
• Effectively manage DDQ resources and budgeting.
• Participate in hiring, training, and development of DDQ staff.
• Coach and develop direct reports to meet quality objectives.
• Align DDQ goals with regulatory expectations and corporate quality strategy.

Conoscenze

Regulatory knowledge

System validation

Quality systems

Formazione

Bachelor's degree in Science/IT/Engineering

Master's degree in Science/IT/Engineering/Business

Ph.D. in Science/IT/Engineering/Business

Descrizione del lavoro

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.

Education

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

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

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.

Equal Employment Opportunity Employer Statement

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

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.

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

Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA.

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.

Requisition ID: R425541