QA Manager

American Regent, Inc.•Brea, CA

21h•$117,900 - $124,000

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 manager serves as the lead Quality point of contact for assigned projects and supports pharmaceutical lifecycle activities, including process development, commercial manufacturing, and drug-product testing and release. The role works directly with CMOs on change management, validation, batch disposition, investigations, Annual Product Reviews (APRs), and supplier change decisions. The position provides day-to-day quality oversight for external manufacturing partners worldwide, helping ensure compliance with cGMP, Quality Agreements, regulatory standards, and the American Regent Quality Management System. It supports commercial distribution and timely product launches, technical transfers, regulatory filing activities, product release, CMO performance monitoring, inspections, and quality risk management. The manager also coordinates decisions and information flow between CMOs and American Regent teams, reviews and approves quality documentation, and develops policies and procedures for managing external manufacturers and service providers. The role requires independent judgment, effective collaboration across functional areas, and the ability to manage multiple priorities. Domestic or international travel of 5–10% is preferred. The expected annual salary range is $117,900–$124,000. American Regent offers a competitive total rewards package that includes healthcare, life insurance, profit sharing, paid time off, matching 401(k), and other benefits.

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, prioritize tasks, and 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 exercise independent judgment and discretion.

Nice To Haves

Experience in External Quality Management and sterile injectables is preferred.
Direct experience participating in and supporting regulatory inspections and submissions is preferred.
Ability to travel domestically or internationally 5–10% is preferred.
Experience using or governing electronic Quality Systems is preferred.

Responsibilities

Provide day-to-day quality input and oversight for lifecycle development and commercialization of pharmaceuticals at global 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 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 engineering, validation, and registration-batch manufacturing, as well as timely document review and approval.
Facilitate approval or release of commercial product based on conformance to specifications, cGMP requirements, and contractual agreements.
Verify that corrective actions to prevent recurrence are completed on time and are consistent with the stated corrective action.
Investigate and determine the need for, and manage, field alerts or recalls and withdrawals for 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 create a quality business review process.
Initiate and attend periodic meetings with CMOs as the American Regent QA representative.
Make quality decisions on 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 for product shipments between American Regent and CMOs.
Monitor, track, and trend CMO batch dispositions; maintain CMO task-tracking documents and share updates with relevant 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.