Compliance QA Manager
Exelixis
4 hours ago
Remote friendly (Alameda, CA)
United States
Operations
Responsibilities:
- Coordinate and maintain inspection readiness activities for regulatory inspections, third-party audits, and mock inspections (notification, logistics, inspection room prep, records).
- Improve inspection readiness tools, templates, and training materials.
- Manage inspection documentation (notifications, document requests, presentations/storyboards) within validated systems and repositories.
- Assess functional area inspection observation responses and associated CAPAs.
- Support clinical site inspection logistics across cross-functional groups and the CRO.
- Collect, track, and trend inspection observation themes; provide data for quality system management reviews.
- Support continuous inspection readiness (mock inspections, logistics drills, document readiness reviews, best practices).
- Coordinate vendor audit preparation, post-audit activities, and quality risk assessments.
- Stay current on regulatory requirements for product quality, data integrity, and supplier management.
- Provide support to QA Partners; other duties as required.
Qualifications:
- Bachelor’s in biology/sciences or related STEM + 7 years relevant experience; or Master’s + 5 years; or equivalent education/experience.
- 5–8+ years GxP QA/quality compliance with inspection readiness exposure and support of regulatory inspections/audits.
Skills:
- Strong written/oral communication; detail-orientation and organization.
- Experience with health authority inspections (prep, document review, coordination, post-inspection actions).
- Problem-solving, influence decision-makers, handle ambiguity/complexity; cross-functional teamwork.
- Ability to contribute to objectives/KPIs; independent work; strong Microsoft Office skills.
Benefits (as stated): 401(k) with company contributions, medical/dental/vision, life/disability, flexible spending, discretionary annual bonus (or sales incentive), stock purchase, long-term incentives, vacation/holidays, sick days.
- Coordinate and maintain inspection readiness activities for regulatory inspections, third-party audits, and mock inspections (notification, logistics, inspection room prep, records).
- Improve inspection readiness tools, templates, and training materials.
- Manage inspection documentation (notifications, document requests, presentations/storyboards) within validated systems and repositories.
- Assess functional area inspection observation responses and associated CAPAs.
- Support clinical site inspection logistics across cross-functional groups and the CRO.
- Collect, track, and trend inspection observation themes; provide data for quality system management reviews.
- Support continuous inspection readiness (mock inspections, logistics drills, document readiness reviews, best practices).
- Coordinate vendor audit preparation, post-audit activities, and quality risk assessments.
- Stay current on regulatory requirements for product quality, data integrity, and supplier management.
- Provide support to QA Partners; other duties as required.
Qualifications:
- Bachelor’s in biology/sciences or related STEM + 7 years relevant experience; or Master’s + 5 years; or equivalent education/experience.
- 5–8+ years GxP QA/quality compliance with inspection readiness exposure and support of regulatory inspections/audits.
Skills:
- Strong written/oral communication; detail-orientation and organization.
- Experience with health authority inspections (prep, document review, coordination, post-inspection actions).
- Problem-solving, influence decision-makers, handle ambiguity/complexity; cross-functional teamwork.
- Ability to contribute to objectives/KPIs; independent work; strong Microsoft Office skills.
Benefits (as stated): 401(k) with company contributions, medical/dental/vision, life/disability, flexible spending, discretionary annual bonus (or sales incentive), stock purchase, long-term incentives, vacation/holidays, sick days.