Quality Control Manager - Oncology
Meet Life Sciences is looking for Quality Control Manager - Oncology in Not Specified, MN.
This local job opportunity with ID 3638880775 is live since 2026-04-15 04:47:02.
We are seeking an experienced Quality Control Manager to lead a small team within a dynamic organization focused on advanced biologics, including viral vector and cell/gene therapy platforms. This role is responsible for overseeing QC testing programs, ensuring product quality, and supporting analytical and regulatory initiatives across the development pipeline.
Key Responsibilities
- Manage and supervise a team of QC professionals, including scheduling and workload planning
- Oversee GMP-compliant testing across various sample types, including:
- Lead stability studies and data trending to ensure product consistency and compliance
- Review and interpret analytical data, ensuring integrity and alignment with SOPs and regulatory requirements
- Investigate deviations, OOS/OOT results, and implement CAPAs in collaboration with QA and leadership
- Mentor and develop QC staff in GMP best practices and quality systems
- Oversee laboratory equipment performance, maintenance, and troubleshooting
- Drive continuous improvement initiatives and foster a high-performance team culture
Qualifications
- Education & Experience: Advanced degree (PhD or equivalent) with 4+ years of relevant experience, or
- Bachelor's degree with 9+ years of relevant experience
- Minimum 3+ years in biologics or advanced therapy QC (e.g., cell/gene therapy, viral vectors)
- Strong understanding of Quality Management Systems (QMS) and assay lifecycle (qualification/validation)
- Hands-on experience with analytical instrumentation and troubleshooting
Knowledge of:
- cGMP standards
- ICH guidelines
- Regulatory expectations (FDA, EMA) for advanced therapies
- Excellent analytical, documentation, and communication skills
- Ability to work independently and lead cross-functional initiatives
Leadership & Work Style
- Proven ability to lead and mentor technical teams
- Strong organizational and problem-solving skills
- Comfortable operating in a fast-paced, evolving environment
- Continuous improvement mindset with strong attention to detail