Senior Manager / Associate Director, Quality Operations
New
United StatesFull-TimeManager
Salary not disclosed
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Job Details
- Experience
- 8-10+ years of progressive quality leadership experience in cell therapy, biotechnology, or biologics, and at least 5 years in cell therapy
- Required Skills
- GCP
Requirements
- Bachelor’s or Master’s degree in Life Sciences, Engineering, or related field.
- 8-10+ years of progressive quality leadership experience in cell therapy, biotechnology, or biologics.
- At least 5 years of experience specifically in cell therapy environments.
- Leadership responsibilities in GMP and/or GCP environments.
- Deep expertise in cell therapy or ATMP manufacturing and GxP quality systems.
- In-depth understanding of ICH, FDA regulations, and global regulatory requirements.
- Demonstrated success in QA operations compliance oversight for external manufacturing.
- Experience overseeing CDMOs, CROs, CTLs, and logistics providers.
- Proven experience supporting regulatory inspections and health authority interactions.
- Ability to travel approximately 30-40% to CDMOs, CROs, clinical sites, and meetings.
Responsibilities
- Provide quality oversight for GxP partners including CDMOs, CROs, laboratories, and logistics providers.
- Manage supplier qualification, performance monitoring, and lifecycle activities for external service providers.
- Maintain quality agreements, risk-based oversight plans, and lead supplier audits and business reviews.
- Oversee batch disposition, deviations, investigations, CAPAs, and change controls for GMP manufacturing.
- Partner cross-functionally with CMC, clinical operations, and regulatory affairs on process validation and product lifecycle activities.
- Ensure clinical trial execution compliance and support CRO governance and regulatory inspection readiness.
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