Executive Director, QC Operations
- Philadelphia, PA
- Permanent
- Full-time
- Represent Quality Control in helping to guide the company through short- and long-term objectives.
- Ensure that all lot testing and release activities are efficient, coordinated for each lot, and executed as planned.
- Ensure that QC quality record requirements and targets are met and tracked.
- Ensure that reporting functions are adequately organized, supervised, and staffed. Intervene, where necessary, to expedite decision making or to meet target timelines.
- Ensure successful method transfer, qualification, validation, and training for all Iovance products.
- Provide technical direction to, and gain alignment across, functions who are problem solving. Contribute to strategic and tactical decisions based on sound Quality principles and available data.
- Minimum 15 years experience in the Pharmaceutical/Biotechnology industry, with extensive leadership experience in commercial QC roles. Cell therapy experience is required.
- Confident, independent, self-starter, who is proactive, and results oriented.
- Experienced overseeing US and EU commercial manufacturing.
- Expert knowledge of Health Authority expectations and industry practices in the US and Europe.
- Expert knowledge of FDA and ICH GxP regulations and guidelines.
- Effective negotiation, communication, listening and writing skills. Exceptional ability to develop open, candid, and collaborative working relationships with diverse stakeholders including C-Suite.
- Medical insurance PPO, HMO & HSA
- Dental & Vision insurance
- 401k plan
- Employee Assistance Program
- Long-term disability
- Weekly payroll
- Expense reimbursement
- Online timecard approval