Manager, Quality Operations - United States
- Our company is a biopharmaceutical company engaged in the development of innovative cancer immunotherapies with a goal of providing rapid, long-term durable response and eliminating the burden of chronic care.
- The company is focused on chimeric antigen receptor (CAR) and T cell receptor (TCR) engineered cell therapies designed to empower the immune system's ability to recognize and kill tumors.
Responsibilities (include but are not limited to):
- Receipt and disposition of incoming materials.
- Review batch-related documentation, and ensures resolution of issues to release product.
- Perform product disposition and lot closure.
- Oversee the packaging and shipping process; authorize shipment.
- Ensure all product-related Deviations are initiated, investigated and resolved.
- Ensures that associated CAPAs are nitiated and resolved, as needed.
- Implement QA on the floor processes, including batch record review.
- Ensure process control measures are in place and followed in product manufacturing.
- Maintain metrics related to batch record review and product disposition in support of the Management Review.
- Schedule staff to support manufacturing and packaging processes in order to ensure on-time delivery of product to patients.
- Train, manage, and coach staff.
- Bachelor’s degree in the biological sciences or related field.
- Minimum of 7 years’ progressive quality or manufacturing experience in a pharmaceutical, biotech, or biologics operation
- Minimum of 2 years of management/leadership experience
- Working knowledge and ability to apply GMPs in conformance to U.S. and EU standards
- Ability to effectively negotiate and build collaboration amongst individuals
- Demonstrated ability to train, manage, and coach staff
- Good interpersonal, verbal and written communication skills
- Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities