Arrowhead Pharmaceuticals

Biopharmaceutical

Manager,DataIntegrity

$115–130k Verona, Wisconsin, United States
Market Sentiment
HIGH DEMAND

Neural analysis suggests this role is
optimal for Manager candidates.

The Brief

“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.

Biopharmaceutical
Problems you'll solve

Solutions-focused

Eligibility Requirements

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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