Manager, Quality Operations

Company: Softworld Inc
Location: Durham
Posted on: May 14, 2025

Job Description:

Job Title: Manager, Quality Operations

To be considered for an interview, please make sure your application 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-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**

Keywords: Softworld Inc, Greensboro , Manager, Quality Operations, Executive , Durham, North Carolina