Manager, Quality Operations Job at Softworld, a Kelly Company, Durham, NC

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  • Softworld, a Kelly Company
  • Durham, NC

Job Description

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**

Job Tags

For subcontractor,

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