Manager, Computer Systems Assurance and Validation
Arrowhead Pharmaceuticals
4 days ago
On-site
Los Angeles, CA
IT
The Manager, Computer Systems Assurance and Validation is a subject matter expert (SME) and project owner responsible for leading and executing computer system validation and assurance activities across the organization.
Responsibilities:
- Collaborate with Quality Assurance and IS leaders to develop and implement risk-based CSA/CSV strategies and frameworks (CSA, GAMP 5) aligned with global regulatory requirements and best practices.
- Drive adoption of CSA principles for validation, shifting from traditional CSV to risk-based methodologies.
- Serve as an SME on validation and compliance; advise stakeholders on software validation and assurance best practices.
- Maintain awareness of evolving regulatory expectations and update policies/procedures accordingly.
- Partner with Quality and cross-functional teams to mature validation processes and quality systems (scalable, audit-ready).
- Own and execute the full validation lifecycle for GxP systems (planning, risk assessment, testing, reporting, periodic review).
- Execute and/or oversee validation activities; serve as signatory on deliverables where appropriate.
- Author validation deliverables (system requirements, validation plans, URS, test scripts, traceability matrices, validation reports).
- Apply risk-based testing strategies and lead system assurance activities (periodic reviews, change management, decommissioning).
Requirements:
- Bachelor’s degree in Computer Science, Information Systems, Life Sciences, Engineering, or related field.
- 8+ years CSV/CSA experience in pharmaceutical/biotech/medical device.
- Strong knowledge of FDA 21 CFR Part 11, EU Annex 11, GAMP 5, and ICH guidelines.
- Demonstrated risk-based validation experience (CSA, GAMP 5).
- Proven ability to lead validation projects as a cross-functional SME.
- Strong communication/influence/problem-solving; independent, proactive, ownership-oriented.
Preferred:
- Advanced degree.
- Experience validating both pure software (SaaS/cloud) and embedded/integrated software (lab/manufacturing equipment).
- Experience improving quality processes/SOPs/validation frameworks in regulated environments.
- Experience with QMS and electronic validation tools.
- Experience supporting regulatory inspections/audits.
Application instructions:
- Candidates must have current, valid authorization to work in the country where this role is located.
Responsibilities:
- Collaborate with Quality Assurance and IS leaders to develop and implement risk-based CSA/CSV strategies and frameworks (CSA, GAMP 5) aligned with global regulatory requirements and best practices.
- Drive adoption of CSA principles for validation, shifting from traditional CSV to risk-based methodologies.
- Serve as an SME on validation and compliance; advise stakeholders on software validation and assurance best practices.
- Maintain awareness of evolving regulatory expectations and update policies/procedures accordingly.
- Partner with Quality and cross-functional teams to mature validation processes and quality systems (scalable, audit-ready).
- Own and execute the full validation lifecycle for GxP systems (planning, risk assessment, testing, reporting, periodic review).
- Execute and/or oversee validation activities; serve as signatory on deliverables where appropriate.
- Author validation deliverables (system requirements, validation plans, URS, test scripts, traceability matrices, validation reports).
- Apply risk-based testing strategies and lead system assurance activities (periodic reviews, change management, decommissioning).
Requirements:
- Bachelor’s degree in Computer Science, Information Systems, Life Sciences, Engineering, or related field.
- 8+ years CSV/CSA experience in pharmaceutical/biotech/medical device.
- Strong knowledge of FDA 21 CFR Part 11, EU Annex 11, GAMP 5, and ICH guidelines.
- Demonstrated risk-based validation experience (CSA, GAMP 5).
- Proven ability to lead validation projects as a cross-functional SME.
- Strong communication/influence/problem-solving; independent, proactive, ownership-oriented.
Preferred:
- Advanced degree.
- Experience validating both pure software (SaaS/cloud) and embedded/integrated software (lab/manufacturing equipment).
- Experience improving quality processes/SOPs/validation frameworks in regulated environments.
- Experience with QMS and electronic validation tools.
- Experience supporting regulatory inspections/audits.
Application instructions:
- Candidates must have current, valid authorization to work in the country where this role is located.