What are the responsibilities and job description for the Quality Assurance Manager position at Advanced Recruiting Partners?
Position Overview
The QA Manager will serve as a key member of the Quality team, working closely with cross-functional groups to oversee contract manufacturing organizations and qualified suppliers. This role will act as the primary quality representative for one or more external partners, ensuring timely and compliant batch disposition processes throughout the product lifecycle.
The QA Manager will uphold internal quality standards and ensure that manufacturing and Quality Control/Assurance records meet defined specifications, industry standards, and phase-appropriate cGMP requirements. This position will also lead activities related to manufacturing and product release and will review quality system documentation generated by CMOs/contract labs to ensure issues are appropriately documented and resolved.
This role requires strong knowledge of regulatory guidance, including cGMP, ICH, FDA, and EU standards, and includes supporting regulatory submissions and agency interactions.
Key Responsibilities
- Provide on-site Quality support for cross-functional initiatives and product lifecycle activities.
- Collaborate with CMOs and internal stakeholders to ensure quality compliance and final product conformity to all specifications.
- Oversee CMO activities, including manufacturing, analytical testing, protocol/report reviews, and stability programs.
- Support quality system readiness and promote a culture of continuous improvement in preparation for PPQ and commercial manufacturing.
- Implement and execute oversight strategies to ensure compliant systems and processes from development through commercialization.
- Encourage and foster a strong quality mindset across internal teams and external partners.
- Review and ensure timely closure of deviations, CAPAs, and change controls with appropriate escalation as needed.
- Support the design, development, and implementation of cGMP Quality Systems at external manufacturing and testing sites.
- Prepare batch-related metrics for Quality Management Reviews and effectively present updates and insights to senior leadership.
- Build and maintain productive relationships with internal and external partners, clearly defining responsibilities and providing sound QA guidance.
Minimum Qualifications
- 5 years of Quality Assurance experience, including exposure to clinical development through commercialization.
- Proven experience working with CMOs and managing product disposition timelines.
- Hands-on experience with batch record review and lot release, particularly for cell or gene therapy products.
- Deep understanding of global regulatory guidelines (cGMP, ICH, FDA, EMA).
- Strong problem-solving skills with a demonstrated ability to resolve quality issues independently.
- Excellent verbal and written communication skills; capable of effective negotiation with external partners.
- Highly organized, adaptable, and comfortable working in a dynamic, fast-paced environment.
