Senior Manager, GxP Systems & Validation

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 & San Diego, CA, and a state of the art manufacturing facility in Verona, WI. Our employees are nimble, science-driven innovators who are collaborating to bring new therapies to patients in need.

The Senior Manager GxP Systems & Validation provides strategic and operational leadership for GxP-regulated computerized systems across their full lifecycle. This role is accountable for governance, validation strategy, inspection readiness, and compliant system administration, ensuring alignment with global regulatory requirements (FDA, EMA, MHRA, ICH) and evolving industry standards (GAMP 5, CSA).

This leader serves as a key partner to Manufacturing, Quality, CMC, CSA and Compliance, GLP Operations, and external vendors, driving scalable compliance frameworks while enabling business agility. The role combines system ownership and administration, validation project management, and organizational oversight to ensure enterprise-wide data integrity and computerized system compliance.

Responsibilities

Maintain governance frameworks for GxP computerized systems

Define validation strategies aligned with GAMP 5 and CSA principles

Support modernization initiatives (e.g., SaaS adoption, cloud validation, CSA transition)

Serve as system owner and system administrator for critical GxP platforms

Maintain validation and system lifecycle policies and standards

Participates in continuous improvement of validation methodologies, templates, and risk-based approaches

Provide compliance guidance to executive leadership and functional heads

Oversee administration and compliant operation of GxP systems (Laboratory systems, LIMS, MES, EDMS, enterprise SaaS platforms)

Ensure systems remain validated, secure, and audit-ready throughout implementation, upgrades, and decommissioning

Approve system configurations, changes, and access governance frameworks

Ensure robust data integrity controls in accordance with ALCOA+ principles

Monitor system performance, audit trails, cybersecurity controls, and vendor compliance

Lead enterprise validation initiatives across multiple concurrent projects

Oversee development and approval of validation deliverables (URS, Risk Assessments, IQ/OQ/PQ, Traceability, Summary Reports)

Ensure appropriate application of risk-based validation and CSA methodologies

Manage validation master planning and resource allocation

Provide oversight of regression testing and revalidation strategies

Ensure validation documentation supports global inspection readiness

Act as SME during regulatory inspections and internal audits

Oversee remediation efforts related to audit findings, deviations, and CAPAs

Maintain awareness of evolving global regulatory expectations

Lead cross-functional teams across CMC, Quality, IS&I, Manufacturing, Engineering, GLP Operations, and external partners

Oversee third-party vendors and validation consultants

Manage budgets, timelines, risks, and resource planning for validation programs

Drive issue resolution and escalation management

Ensure vendor deliverables meet compliance and quality standards

Lead, mentor, and develop validation and system administration staff

Establish performance expectations and competency development plans

Build scalable team capabilities to support business growth

Bachelor’s degree in Life Sciences, Engineering, IT, or related discipline (advanced degree preferred)

8+ years of experience in GxP computerized systems and validation

3+ years in a leadership or program management role

Deep expertise in CSV/CSA, GAMP 5, 21 CFR Part 11, Annex 11, and global data integrity requirements

Demonstrated experience leading complex, enterprise-level system implementations

Strong understanding of change control, deviation management, CAPA, and quality systems

Proven ability to influence senior stakeholders and drive cross-functional alignment

PMP or equivalent project management certification

GAMP, ITIL, or related compliance certification

Experience leading CSA transformation initiatives

Extensive experience related to administration, operation, and maintenance of Laboratory Information Management Systems (LIMS) Chromatography Data Systems, Spectrophotometry Systems, and ancillary/supporting laboratory systems in a GxP environment (Openlab, Cary UV systems, Watson)

Pharmaceutical or CRO experience

Prior regulatory inspection leadership experience

Risk-based decision making

Continuous improvement mindset

Wisconsin pay range

$145,000—$165,000 USD

Arrowhead provides competitive salaries and an excellent benefit package.

Candidates must have current, valid authorization to work in the country where this role is located.

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