QA Manager

Bimeda•Pomona, CA

5d•Onsite

About The Position

Reporting to the QA Director, the QA Manager is responsible for leading quality systems and compliance activities to support product delivery and regulatory readiness. This role ensures adherence to cGMP, QSR, GDP, and other applicable standards. The QA Manager oversees quality-related investigations, audits, customer support, and continuous improvement initiatives. The role manages a team of QA Associates and works cross-functionally to resolve quality events and maintain operational excellence.

Requirements

5–7 years of experience in a regulated pharmaceutical industry, including Quality Assurance and Quality Control.
Minimum 2–3 years in a leadership role.
BSc degree in scientific discipline.
Strong knowledge of cGMP, Quality Systems, Drug Regulatory Affairs, and stability protocols.
Proven leadership and communication skills across all organizational levels.
Ability to manage competing priorities in a fast-paced environment.

Nice To Haves

MS degree or MBA.

Responsibilities

Ensure ongoing compliance with local, national, and international standards and legislation.
Lead quality systems and monitoring activities to support product release and regulatory compliance.
Liaise with customers to manage quality-related requests, corrective actions, and specifications.
Oversee the quality process related to product shipment and delivery, ensuring timelines and KPIs are met.
Lead and support internal audits, Health Authority inspections, and customer audits.
Ensure CAPAs are tracked, implemented, and remediated in a timely manner.
Manage investigations into batch discrepancies, non-conformances, and out-of-specification events; ensure root cause analysis and corrective actions are completed.
Ensure product quality complaints are investigated, trended, and resolved in collaboration with relevant departments.
Monitor quality system performance through KPIs and publish metrics with recommendations for improvement.
Provide direction to direct reports regarding priorities, trials, audits, new projects, and client visits.
Develop and implement project management strategies for quality initiatives.
Achieve results through direct reports by setting goals, coaching, reviewing performance, and supporting development.
Ensure cross-training of team members to support operations.
Accomplish financial objectives by forecasting requirements, preparing budgets, analyzing variances, and initiating corrective actions.
Lead by example and foster collaboration across internal teams and external stakeholders.