Digital & Data Quality Director - US

Merck

West Point, PA

Shift: Full time

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: 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 Skills: Current Employees apply HERE Current Contingent Workers apply HERE US and Puert