Job Title: Manager, Quality Operations

Job Location: Durham, North Carolina

Onsite Requirements:

• Experience in Gene Therapy
• Analytical QC experience
• CMO oversight

Job Description:

PRIMARY RESPONSIBILITIES:

• Provide on-site Quality support to the cross-functional team.
• Partner with CMO and Client team members to ensure end-to-end quality remains in a compliant state, and the final product meets all required standards and specifications.
• Provide quality oversight of CMO activities, including manufacturing, analytical testing, protocol and report development and review, and stability testing.
• Promote a culture of continuous improvement with Client partners (CMOs) in preparation for PPQ and commercial activities.
• Execute CMO oversight strategy to ensure appropriate quality system controls in support of all phases of the product lifecycle from development through commercialization.
• Foster a quality mindset within both internal and external teams, working collaboratively to achieve compliant processes.
• Perform the review and facilitate timely closure of deviations, CAPAs, and change controls, ensuring appropriate escalation, as applicable.
• Supports the development and implementation of GMP Quality Systems at the CMO, as needed.
• Compile batch-related metrics in preparation for Quality Management Review Meetings and effectively communicate status and recommendations to Senior Management.
• Facilitate robust relationships with both internal and external partners, clearly defining responsibilities, and providing effective QA guidance.

SKILL & EDUCATION REQUIREMENTS:

• 5+ years Quality Assurance experience, ideally with early clinical phases through commercialization.
• Direct experience working with operations or CMOs to meet product disposition timelines.
• Experience with cell or gene therapy batch record review and lot release.
• Strong knowledge of cGMP/ICH/FDA/EMA regulations.
• Strong individual effectiveness in the resolution of quality issues.
• Excellent written and verbal communication skills, including the ability to communicate and negotiate with external partners.
• Excellent organizational skills, ability to navigate and be successful in a fast-paced work environment with changing priorities.
• Travel up to 25%, as needed.
• Experience and understanding of analytical validation of methods and release testing, preferred.
• QA lead during troubleshooting efforts to support cGMP investigations (OOS or Major Deviations).
  
  

**3rd party and subcontract staffing agencies are not eligible for partnership on this position. 3rd party subcontractors need not apply.

• This position requires candidates to be eligible to work in the United States, directly for an employer, without sponsorship now or anytime in the future**