Digital & Data Quality Director - US

Merck•Upper Gwynedd Township, PA

1d•$173,200 - $272,600•Hybrid

About The Position

The Digital and Data Quality (DDQ) Director leads the DDQ organization and manages quality aspects of GMP computerized systems used by the Company Manufacturing Division. This includes IT applications, automated manufacturing and packaging equipment, automated laboratory systems, data analysis tools, and emerging technologies. The Director ensures compliance with company policies, procedures, and regulatory expectations across assigned areas. The role oversees quality activities for computerized systems supporting site and above-site GMP processes; systems required by the Company Manufacturing Division Quality Manual; systems that may affect product quality, patient safety, or data integrity; and GMP data controls throughout the data lifecycle. The Director works closely with stakeholders and management in Quality Operations, Business Units, External Manufacturing, Manufacturing, and Information Technology. Responsibilities must be performed independently, with integrity, fairness, and objectivity to protect products and patients.

Requirements

Bachelor's degree in Science, Information Technology, Engineering, or a related field; alternatively, a master's degree in a specified discipline with at least 12 years of experience in regulated pharmaceutical manufacturing and delivery of validated enterprise systems; or a Ph.D. in a specified discipline with at least 7 years of that experience.
Expert knowledge of applicable regulations and guidance, including FDA and EU regulations, ICH guidelines, 21 CFR Part 11, 21 CFR Parts 210, 211, and 820, EU Annex 11 and Annex 15, data integrity requirements, local regulatory expectations, and industry standards such as GAMP.
Extensive hands-on experience with principles, theories, and concepts of computerized system validation and compliance.
Practical experience implementing quality systems in pharmaceutical, laboratory, biotechnology, or related regulated manufacturing environments.
Integrity, fairness, and objectivity in decision-making.
Ability to lead teams effectively in a highly regulated environment and align resources with strategic and regulatory priorities.
Ability to build partnerships across Quality, Manufacturing, Business, and Information Technology organizations and drive compliance, quality, and data integrity throughout the computerized system lifecycle.
Skills listed as required: 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, and Strategic Thinking.

Nice To Haves

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 oversight area.
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, and medical devices, and of risk management.
Strong business engagement skills and ability to collaborate effectively with technical and non-technical stakeholders.
Expertise in negotiation, facilitation, cross-functional relationship building, and 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 to changing business priorities, technologies, and regulatory requirements.

Responsibilities

Lead the Digital and Data Quality organization and manage quality aspects of GMP computerized systems.
Ensure compliance with company policies, procedures, and regulatory expectations across assigned areas.
Oversee quality activities for computerized systems supporting GMP processes, systems required by the Company Manufacturing Division Quality Manual, systems with potential product quality, patient safety, or data integrity impact, and GMP data controls throughout the data lifecycle.
Work closely with stakeholders and management from Quality Operations, Business Units, External Manufacturing, Manufacturing, and Information Technology.
Support regulatory inspections and audits.
Manage DDQ resources effectively and efficiently.
Participate in hiring, training, development, and management of DDQ employees.
Coach and develop direct reports.
Align team and individual goals proactively with regulatory expectations and Company Manufacturing Division quality objectives.
Model and reinforce the company's leadership behaviors, values, and culture.
Lead teams in a highly regulated environment and align organizational resources with strategic and regulatory priorities.
Promote continuous improvement and operational excellence, build cross-functional partnerships, and drive compliance, quality, and data integrity throughout the computerized system lifecycle.