Forge Biologics
Associate Manager, QA Operations - AAV Manufacturing (2nd Shift)
Columbus, Ohio · Senior
Sponsorship not specifiedDetected 1 day ago
ExcelProcess ImprovementEmployee RelationsGMPFDA RegulatoryCRISPRCommunicationMentoringMicrosoft Office
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About the role
- The Associate Manager, Quality Assurance - AAV Manufacturing is responsible for the supervision and development of junior members of the Quality Assurance team and helping oversee AAV GMP manufacturing activities.
Responsibilities
- Perform detailed review and approval of batch records and associated documentation for AAV gene therapy manufacturing, logbooks, and other controlled documentation ensuring adherence to established procedures and cGMP regulations.
- Collaborate with cross-functional teams, including Process Development, Analytical Development, and Manufacturing, to support continuous process improvement initiatives and ensure alignment with quality objectives.
- Support the documentation control process for AAV gene therapy manufacturing, including creation, revision, review, and approval of batch records, SOPs, work instructions, and forms to ensure compliance with regulatory requirements and industry best practices.
- Support deviations and continuous improvements related to AAV gene therapy manufacturing processes, assist with root cause analysis and identification of CAPA measures to prevent recurrence.
- The Associate Manager will supervise junior members of the Quality Assurance team in activities such as document control, batch record review, and maintain ing a QA presence in AAV gene therapy manufacturing areas.
Requirements
- Bachelor's Degree (B.A. or B.S.) in scientific-related field or engineering (or equivalent work experience).
- Proficiency with Microsoft Office applications, including Outlook, Teams, Word, Excel, and PowerPoint.
- 6 + years in a Q uality A ssurance or related role within the pharmaceutical or biotechnology industry.
- Experience mentoring and developing junior team members, including providing guidance on QA best practices and fostering professional growth.
- Thorough understanding of pharmaceutical cGMP requirements and strong working knowledge of FDA and EU requirements/guidance documents.
- Experience using an Electronic Quality Management System, preferably Veeva Vault or a comparable document management platform.
- Ability to collaborate with cross-functional technical groups to resolve issues, close gaps, and ensure compliant outcomes which are efficient and robust.
- Ability to manage competing priorities in a fast-paced, deadline-driven environment while maintaining accuracy, completeness, and compliance.
- Ability to work the hours necessary to support production and participate in an on-call rotation providing off-hours support for AAV manufacturing needs and issues. <span data-ccp-props="{"134233117":false,"134233118":false,"335559738"
Skills
- Your Future with Us:
- to enable access to life-changing gene therapies and help bring them from ideas into reality.
- At Forge, your growth matters.
Benefits
- Assist management in setting clear vision by ensuring goals and objectives are aligned with departmental goals and supervising each junior team member's team support.
Company info
- Forge Your Future with Us: At Forge Biologics, we believe in turning bold ideas into life-changing realities.
- Our mission is simple yet powerful: to enable access to life-changing gene therapies and help bring them from ideas into reality.
- Here, you won't just watch innovation happen - you'll be part of it.
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This listing is sourced directly from Forge Biologics's careers page and normalized into a canonical job model.