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Manager, Quality Assurance
Avid BioservicesUnited Statesfull_timeVerifiedPosted 6 Nov 2025
💰 $123,000/yr($107,300/yr – $123,000/yr)
About the role
Looking to join a passionate team dedicated to developing and manufacturing life-saving biopharmaceuticals? Avid Bioservices is a leading clinical and commercial biologics CDMO focused on creating innovative solutions to meet the needs of our clients and improve patient outcomes. Your Role: The Manager, Quality Assurance role, will manage and maintain quality management system (QMS) activities. Provide technical review of quality system records. Solve a wide range of issues that impact multiple functions, following cGMP regulations and company standards. Perform assigned tasks and work to achieve company goals and department objectives. Select, develop, and evaluate personnel to ensure the efficient and compliant operation of the function.
- Manage Avid’s QMS including discrepancy reports and corrective and preventive actions (CAPAs); manage team of QS associates responsible for administration of the QMS.
- Author, review, edit, and approve discrepancy reports including, but not limited to, reports for deviations, calibration exceptions, out-of-specification (OOS) results, and out-of-limit (OOL) results; ensure discrepancy reports meet procedural and regulatory requirements, including requirements for root cause analysis and impact assessment.
- Author, review, edit, and approve CAPA records; ensure CAPA records meet procedural and regulatory requirements.
- Interact with interdepartmental contacts on discrepancy reports, CAPA records, controlled documents, and other Quality topics; represent Quality on multi-disciplinary teams.
- Maintain a state of inspection readiness; participate in inspection preparation activities.
- Identify, design, and implement continuous improvement projects and solutions to potential procedure, process, and system gaps.
- Independently manage competing priorities with limited instruction.
- Provide assistance to internal and external customers in support of departmental functions.
- Follow company policies and procedures.
- Train personnel and internal customers on relevant quality processes.
- Perform other duties as assigned.
- Directs activities of functional areas for direct reports.
- B.A. or B.S. degree (preferably in Life Science) and 7 years’ experience in the pharmaceutical or biopharmaceutical industry, or an equivalent combination of education and experience, with five years in Quality.
- Preferably a minimum of three years of supervisory/management experience.
- Sound knowledge of cGMPs or equivalent regulations.
- Ability to interpret and relate Quality standards for implementation and review.
- Ability to make sound decisions about scheduling, allocation of resources, and managing priorities.
- Ability to communicate clearly and professionally both in writing and verbally.
- Flexibility in problem solving, providing direction and work hours to meet business objectives.
- You have a "bring it on!" team player approach and an unshakable positive attitude, always ready to tackle anything that comes your way.
- Your written and verbal skills are out of this world, and you communicate with clarity and confidence.
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