Associate Director, Computer System Validation & Quality Compliance
Amylyx Pharmaceuticals
5 hours ago
Remote
United States
$170,000 - $191,000 USD yearly
IT
Responsibilities
- Develop, evolve, and steward the corporate CSV/CSA strategy aligned with enterprise digital strategy and QMS objectives.
- Serve as senior Quality authority for computerized systems validation, data integrity, and electronic system compliance.
- Oversee enterprise-wide governance for standardized, risk-based system implementation and maintenance.
- Lead planning, execution, review, and approval of validation deliverables across GxP systems.
- Oversee system lifecycle activities (impact assessments, change management, periodic reviews, audit trails, user access reviews, system retirement).
- Lead Veeva Quality Suite quality SME support (configuration, workflow optimization, release readiness).
- Lead implementation/enhancement/optimization of Veeva Vault modules and integrations; drive automation/digitization.
- Ensure compliance with 21 CFR Part 11, EU Annex 11, GxP principles, and global data integrity expectations.
- Own electronic-systems validation Quality policies/procedures; represent Quality in audits/inspections/vendor assessments.
- Lead remediation, effectiveness checks, continuous improvement, and Quality event oversight/trending (Change Control, Deviations, CAPA).
Required Qualifications
- Bachelor’s degree in a relevant scientific or technical discipline.
- 8+ years life sciences experience with strong GxP computerized system experience.
- Extensive leadership in cross-functional GxP computerized system implementation/validation.
- Deep expertise with Veeva Vault Quality Suite (QMS, Docs, Training).
- Strong knowledge of global regulatory expectations and data integrity frameworks.
- Ability to lead enterprise programs and influence stakeholders for compliant decisions.
Preferred Qualifications
- SaaS/cloud architecture and database compliance knowledge.
- Understanding of clinical data collection technologies.
- Familiarity with SDLC, Agile, CSV vs. CSA, and automated testing.
- Experience with Quality metrics (KPIs/KQIs).
- Excellent collaboration/negotiation/influence skills.
Compensation
- Estimated pay range: $170,000–$191,000 USD.
- Develop, evolve, and steward the corporate CSV/CSA strategy aligned with enterprise digital strategy and QMS objectives.
- Serve as senior Quality authority for computerized systems validation, data integrity, and electronic system compliance.
- Oversee enterprise-wide governance for standardized, risk-based system implementation and maintenance.
- Lead planning, execution, review, and approval of validation deliverables across GxP systems.
- Oversee system lifecycle activities (impact assessments, change management, periodic reviews, audit trails, user access reviews, system retirement).
- Lead Veeva Quality Suite quality SME support (configuration, workflow optimization, release readiness).
- Lead implementation/enhancement/optimization of Veeva Vault modules and integrations; drive automation/digitization.
- Ensure compliance with 21 CFR Part 11, EU Annex 11, GxP principles, and global data integrity expectations.
- Own electronic-systems validation Quality policies/procedures; represent Quality in audits/inspections/vendor assessments.
- Lead remediation, effectiveness checks, continuous improvement, and Quality event oversight/trending (Change Control, Deviations, CAPA).
Required Qualifications
- Bachelor’s degree in a relevant scientific or technical discipline.
- 8+ years life sciences experience with strong GxP computerized system experience.
- Extensive leadership in cross-functional GxP computerized system implementation/validation.
- Deep expertise with Veeva Vault Quality Suite (QMS, Docs, Training).
- Strong knowledge of global regulatory expectations and data integrity frameworks.
- Ability to lead enterprise programs and influence stakeholders for compliant decisions.
Preferred Qualifications
- SaaS/cloud architecture and database compliance knowledge.
- Understanding of clinical data collection technologies.
- Familiarity with SDLC, Agile, CSV vs. CSA, and automated testing.
- Experience with Quality metrics (KPIs/KQIs).
- Excellent collaboration/negotiation/influence skills.
Compensation
- Estimated pay range: $170,000–$191,000 USD.