Arrowhead Pharmaceuticals
Biopharmaceutical
Manager,DataIntegrity
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“Manager, Data Integrity at Arrowhead Pharmaceuticals. Skills: Data integrity, GxP regulations. Identify gaps. Drive hands-on remediation”
What You'll Achieve.
Strengthen data integrity controls
Industry & Context.
Solutions-focused
Occasional business travel
What They're Looking For.
Must Have
Bachelor's degree in science, engineering, information technology, computer science, data management, or a related technical discipline, Minimum of five (5) years of experience in the regulated pharmaceutical, biotechnology, or combination product industry, Demonstrated ability to coordinate or guide team-level work, Comprehensive knowledge of GxP regulations, Knowledge of GMP (FDA, EU, etc.), Knowledge of ICH guidelines, Knowledge of ISO standards, Demonstrated expertise with data integrity principles, Demonstrated expertise with data lifecycle management, Demonstrated expertise with data governance frameworks, Proven experience applying 21 CFR Part 11, Proven experience applying Annex 11, Proven experience applying other relevant regulations, Understanding of information technology, Understanding of data management systems, Understanding of system validation, Understanding of security, Understanding of enterprise data governance, Demonstrated ability to coordinate cross-functional tasks, Demonstrated ability to build effective peer relationships, Demonstrated ability to advance data integrity objectives through influence, Ability to manage competing priorities, Ability to escalate risks appropriately, Ability to deliver on commitments, Written communication, Verbal communication, Previous experience with EDMS / EQMS
Nice to Have
Advanced degree preferred, Certification or formal training in quality management, Certification or formal training in data integrity, Certification or formal training in data governance, Certification or formal training in regulatory compliance, ASQ certification, ISPE certification, PDA certification
What You'll Do.
Drive hands-on remediation
Coordinate data integrity activities
Maintain program momentum
Support compliant data management
Conduct data integrity impact assessments
Track remediation progress
Ensure timely closure
Evaluate data management practices
Evaluate documentation practices
Evaluate record control practices
Flag non-conformances
Support corrective action
Assess computerized systems for compliance
Assess software for compliance
Assess equipment for compliance
Support risk-based validation
Support assurance activities
Participate in data integrity audits
Support data integrity audits
Contribute to risk identification
Contribute to gap analysis
Contribute to mitigation execution
Author process improvement initiatives
Execute process improvement initiatives
Manage direct reports
Mentor direct reports
Support professional development
Build data integrity team capability
Support data integrity training
Deliver data integrity training
Support regulatory inspections
Support partner audits
Prepare documentation
Respond to data integrity inquiries
Support data governance initiatives
Support compliant data management practices
Perform additional duties
How You'll Work.
Team & Collaboration
Cross-functional teams; Peer teams
Communication Scope
Written communication; Verbal communication; Technical compliance requirements
Process & Methodology
Risk management
Full Job Description
Arrowhead Pharmaceuticals, Inc. (Nasdaq ARWR) is a commercial stage biopharmaceutical company that develops medicines that treat intractable diseases by silencing the genes that cause them. Using a broad portfolio of RNA chemistries and efficient modes of delivery, Arrowhead therapies trigger the RNA interference mechanism to induce rapid, deep, and durable knockdown of target genes. RNA interference, or RNAi, is a mechanism present in living cells that inhibits the expression of a specific gene, thereby affecting the production of a specific protein. Arrowhead’s RNAi-based therapeutics leverage this natural pathway of gene silencing. Arrowhead is focused on developing innovative drugs for diseases with a genetic basis, typically characterized by the overproduction of one or more proteins that are involved with disease. The depth and versatility of our RNAi technologies enables us to potentially address conditions in virtually any therapeutic area and pursue disease targets that are not otherwise addressable by small molecules and biologics. Arrowhead is leading the field in bringing the promise of RNAi to address diseases outside of the liver, and our clinical pipeline includes disease targets in the liver and lung with a promising pipeline of preclinical candidates. Arrowhead’s corporate headquarters is in Pasadena, CA with research and development teams in Madison, WI identify gaps and drive hands-on remediation. Coordinate cross-functional data integrity activities, serving as a working-level point of contact to maintain program momentum and support peer teams in adopting compliant data management practices. Conduct data integrity impact assessments, risk evaluations, and remediation plans; track progress and ensure timely closure of commitments. Evaluate data management, documentation, and record control practices across systems and formats; flag non-conformances and support corrective action. Assess computerized systems, software, and equipment for compliance
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