Manager, Quality Operations Position Available In Durham, North Carolina

Job Description:

Job Title:

Manager, Quality Operations To be considered for an interview, please make sure yourapplication is full in line with the job specs as found below.

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-endquality remains in a compliant state, and the final product meetsall required standards and specifications. Provide quality oversight of CMO activities, includingmanufacturing, analytical testing, protocol and report developmentand 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 systemcontrols in support of all phases of the product lifecycle fromdevelopment 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, asapplicable. Supports the development and implementation of GMP Quality Systemsat the CMO, as needed. Compile batch-related metrics in preparation for Quality ManagementReview Meetings and effectively communicate status andrecommendations to Senior Management. Facilitate robust relationships with both internal and externalpartners, clearly defining responsibilities, and providingeffective QA guidance.

SKILL & EDUCATION REQUIREMENTS

5+ years Quality Assurance experience, ideally with early clinicalphases through commercialization. Direct experience working with operations or CMOs to meet productdisposition timelines. Experience with cell or gene therapy batch record review and lotrelease. Strong knowledge of c

GMP/ICH/FDA/EMA

regulations. Strong individual effectiveness in the resolution of qualityissues. Excellent written and verbal communication skills, including theability to communicate and negotiate with external partners. Excellent organizational skills, ability to navigate and besuccessful in a fast-paced work environment with changingpriorities. Travel up to 25%, as needed. Experience and understanding of analytical validation of methodsand release testing, preferred. QA lead during troubleshooting efforts to support cGMPinvestigations (OOS or Major Deviations). •3rd party and subcontract staffing agencies are not eligible forpartnership on this position. 3rd party subcontractors need notapply. This position requires candidates to be eligible to work in theUnited States, directly for an employer, without sponsorship now oranytime in the future•