QA Manager

American Regent•Brea, CA

11d

About The Position

The Quality Assurance Manager, External Manufacturing supports GMP activities for finished-product manufacturing at Contract Manufacturing Organizations (CMOs) and ensures conformance with established quality and compliance requirements. The role serves as the lead Quality point of contact for assigned projects and supports pharmaceutical lifecycle management, including process development, commercial manufacturing, and drug-product testing and release. Work includes direct engagement with CMOs, change management, validation, batch disposition, investigations, annual product review (APR) completion, and supplier-change decisions. The position provides day-to-day quality input and oversight for development and commercialization at global external manufacturing partners, helping ensure compliance with cGMP, Quality Agreements, regulatory standards, and the American Regent Quality Management System. It supports supply-chain operations and product launches through technical transfers, regulatory-filing manufacturing activities, and commercial-product release decisions. The manager reviews and approves third-party quality documentation, conducts and participates in site visits and meetings, supports inspections, manages quality risks and remediation, and develops policies and procedures for oversight of contract manufacturers and external service providers. The role requires independent judgment and collaboration with internal functional teams and external partners.

Requirements

Bachelor’s degree in engineering, a science discipline, or a related field.
Minimum of 8 years of pharmaceutical Quality Assurance experience is preferred.
Strong working knowledge of current Good Manufacturing Practices, FDA requirements, and ICH Q8, Q9, Q10, and Q12 guidelines.
Ability to work independently without supervision and as part of a team.
Excellent communication and interpersonal skills, including oral and written communication.
Ability to plan and organize work activities and prioritize tasks to meet schedules and deadlines.
Strong problem-solving and analytical skills, attention to detail, and ability to manage multiple projects simultaneously.
Experience with Microsoft Office.
Ability to make independent decisions and exercise independent judgment and discretion.

Nice To Haves

Experience in External Quality Management and sterile injectables.
Experience participating in and supporting regulatory inspections and submissions.
Ability and willingness to travel domestically or internationally 5–10%.
Demonstrated experience with the use or governance of electronic Quality Systems.

Responsibilities

Provide day-to-day quality input and oversight for pharmaceutical lifecycle development and commercialization at external manufacturing partners, ensuring compliance with cGMP, Quality Agreements, regulatory standards, and the American Regent Quality Management System.
Establish Quality KPI scorecards to assess third-party finished-product manufacturers’ compliance and performance.
Drive timely decisions and facilitate communication and information flow between CMOs and American Regent functional teams.
Ensure quality and compliance matters meet applicable GMP and regulatory requirements so products are safe, pure, and effective.
Serve as the Quality lead for technical-transfer activities at external manufacturing partners.
Support manufacturing activities related to regulatory filings, including on-site presence for engineering, validation, and registration-batch manufacturing, and timely review and approval of documents.
Facilitate approval or release of commercial product based on conformance to specifications, cGMP requirements, and contractual agreements.
Verify timely completion of corrective actions intended to prevent recurrence and confirm consistency with the stated corrective action.
Investigate and determine the need for, and manage, field alerts, recalls, or withdrawals of company products manufactured by third-party CMOs.
Review and approve third-party quality records and documentation, including change controls, master batch records, API and raw-material records, product specifications, analytical methods, stability and validation protocols and reports, quality incidents and investigation reports, Quality Agreements, and technical-transfer documentation.
Perform on-site visits during manufacturing and packaging of American Regent products and establish a quality business-review process.
Initiate and attend periodic meetings with CMOs as the American Regent Quality Assurance representative.
Make quality decisions concerning CMO- and supplier-related tasks and events.
Provide status updates on CMO-related tasks and action items to internal departments.
Monitor and track relationships between American Regent batches and CMO batches.
Provide information and documentation needed to ship products between American Regent and CMOs.
Monitor, track, and trend batch dispositions from CMOs; create and maintain CMO task-tracking documents and share updates with multiple departments.
Review and approve CMO- and supplier-executed batch records and batch-disposition documents.
Create and provide documents requested by CMOs.
Notify CMOs of internal events requiring third-party notification and follow up on third-party review status as applicable.
Review and approve American Regent batch-disposition documents and create Certificates of Conformance (CoCs).
Support regulatory-agency inspections.
Build and maintain working relationships with American Regent functional areas.
Participate in regulatory and American Regent inspections of external manufacturing partners to support successful outcomes and maintain inspection readiness.
Perform quality risk assessments and drive risk-reduction improvement plans and remediation where necessary.
Develop and revise company policies and procedures for managing third-party CMOs and external service providers.
Develop positive relationships with CMOs while holding them accountable.
Perform other tasks and duties as assigned by management.
Exercise independent judgment and discretion in performing work.