QA Manager – Quality Assurance Lead
bimeda · Pomona
Job description
About the role
The QA Manager will lead quality systems and compliance activities for product delivery and regulatory readiness. Reporting to the QA Director, this role ensures adherence to cGMP, QSR, GDP and other applicable standards while managing a team of QA Associates.
Key responsibilities
- Maintain ongoing compliance with local, national and international regulations.
- Lead quality monitoring, product release and regulatory compliance activities.
- Manage customer quality requests, corrective actions and specifications.
- Oversee shipment quality processes, ensuring timelines and KPIs are met.
- Coordinate internal audits, health‑authority inspections and customer audits.
- Track, implement and remediate CAPAs in a timely manner.
- Investigate batch discrepancies, non‑conformances and OOS events, driving root‑cause analysis and corrective actions.
- Trend and resolve product quality complaints in collaboration with cross‑functional teams.
- Monitor quality system performance through KPIs and publish improvement recommendations.
- Provide direction to direct reports on priorities, audits, projects and client visits.
- Develop project‑management strategies for quality initiatives and ensure cross‑training of team members.
Required profile
- Proven experience leading quality assurance functions in a regulated environment.
- Strong leadership and coaching abilities for a team of QA Associates.
- Ability to work cross‑functionally and communicate with internal and external stakeholders.
- Willingness to work in warehouse and production settings, including occasional exposure to noise, chemicals and machinery.
Required skills
- cGMP
- QSR
- GDP
- CAPA management
- Root cause analysis
- KPI monitoring
- Audit coordination
- Project management
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Published 2 weeks ago
Expires 1 month from now
18 views · 0 interested
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bimeda
Pomona