Quality Control Manager - Oncology

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