Director, Data Integrity

The Position

Provide strategic leadership for the design, implementation, and continuous improvement of the company's data integrity program across GxP operations supporting clinical and commercial pharmaceutical and combination products. Define and oversee company-wide governance frameworks, policies, and requirements to ensure alignment with global data integrity regulations and ALCOA++ principles. Serve as a cross-functional leader and subject matter expert, partnering across the organization to embed data integrity principles and compliance into systems, processes, and culture.

Responsibilities

• Lead the development, implementation, and continuous improvement of data integrity policies, procedures, and program elements in alignment with global regulatory requirements.
• Establish and oversee data integrity governance programs, partnering cross-functionally to drive strategic initiatives and foster a culture of data integrity.
• Develop and maintain systems for data integrity impact assessments, risk evaluations, and remediation plans, ensuring timely completion of commitments.
• Evaluate data management, documentation, and record control practices across systems and formats to ensure compliance with data integrity requirements.
• Implement and maintain processes to assess computerized systems, software, and equipment for compliance with 21 CFR Part 11, Annex 11, and related guidance.
• Lead and oversee comprehensive data integrity audits and assessments to identify risks, gaps, or discrepancies, and lead mitigation and remediation activities.
• Drive corrective and preventive actions and process improvement initiatives to strengthen data integrity controls and system reliability.
• Develop, analyze, and report data integrity metrics and key performance indicators to senior leadership.
• Design and deliver training programs to promote data integrity awareness and ensure consistent understanding across the organization.
• Provide subject matter expertise and support during regulatory inspections and partner audits, articulating data integrity program elements and strategy.
• Monitor global regulations, emerging guidance, and best practices through active engagement with relevant professional organizations (e.g., ISPE, PDA).
• Perform additional duties as assigned to support objectives.

Requirements:

• Bachelor's degree in science, engineering, information technology, computer science, data management, or a related technical discipline.
• Minimum of ten (10) years of experience in the regulated pharmaceutical, biotechnology, or combination product industry, including at least five (5) years in a leadership role with increasing responsibility.
• Comprehensive knowledge of GxP regulations, including GMP (FDA, EU, etc.), ICH guidelines, and ISO standards.
• Demonstrated expertise with ALCOA++ principles, data lifecycle management, and data governance frameworks.
• Proven experience applying 21 CFR Part 11, Annex 11, and other relevant regulations and guidance governing data integrity and information security.
• Strong understanding of information technology and data management systems, including system validation, security, and enterprise data governance.
• Proven ability to lead complex, cross-functional projects and build effective partnerships to advance data integrity and compliance objectives, demonstrating strong organizational, planning, and prioritization skills.
• Strategic thinker with demonstrated success in driving continuous improvement, innovation, and proactive risk management.
• Excellent communication, interpersonal, and leadership skills, with the ability to work with a diverse range of professionals and influence stakeholders at all levels.
• Ability for occasional business travel.

Preferred:

• Advanced degree preferred.
• Certification or formal training in quality management, data integrity, data governance, or regulatory compliance (e.g., ASQ, ISPE, PDA, or equivalent).