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…