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Arrowhead Pharmaceuticals · 3 hours ago

Director, Data Integrity

Verona, WI

Full-time

Onsite

Director/Executive

$180K/yr - $210K/yr

10+ years exp

Arrowhead Pharmaceuticals is a clinical stage biopharmaceutical company focused on developing innovative drugs for diseases with a genetic basis. The Director of Data Integrity will provide strategic leadership for the design, implementation, and continuous improvement of the company’s data integrity program across GxP operations, ensuring compliance with global regulations and fostering a culture of data integrity.

BiotechnologyHealth CareNanotechnologyPharmaceutical

Comp. & Benefits

No H1B

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

Qualification

GxP regulationsALCOA++ principlesData governance frameworks21 CFR Part 11Data lifecycle managementInformation technologyData management systemsPlanning skillsPrioritization skillsLeadership skillsCommunication skillsInterpersonal skillsOrganizational skills

Required

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)