Quality Assurance Operations Manager - Remote

Overview

Iovance Biotherapeutics is a growing company focused on the development and commercialization of immunotherapies based on TIL (Tumor Infiltrating Lymphocytes). The Quality Assurance (QA) Operations Manager position will be integral to providing QA oversight of CMOs (Contract Manufacturing Organizations) for critical materials. The position will help co-ordinate daily quality-related operations between Iovance and CMOs and is responsible for supporting day-to-day GMP QA Operations activities that support manufacturing, testing and release of iPBMCs in a GMP compliant manner. The individual is collaborative, organized, innovative, flexible, with a strong desire to learn and take ownership and accountability.

In Short

• Establish direct lines of communication with the CMO QA, Manufacturing, and QC functions.
• Ensure knowledge and information between the CMO and Iovance are shared in a timely manner.
• Ensure that day-to-day activities for QA Operations and lot disposition are efficient, coordinated, and executed as planned.
• Ensure efficient operations, and compliance with quality standards, cGMPs, safety regulations, and requirements as documented.
• Actively interact with Contract Manufacturing Organizations (CMO), and internal teams to ensure efficient and timely batch release.
• Contribute to strategic and tactical decisions based on sound Quality principles and available data.
• Continuously seek and support new approaches, practices and processes to improve the efficiency and efficacy of the operation.
• Perform review and approval of release documentation.
• Identify, propose, and implement procedural changes to improve controls and product quality.
• Continuously evaluate CMO performance and implement corrective actions as needed.

Requirements

• BS degree in life sciences. Advanced degree a plus.
• At least 10 years of Quality experience in a GMP environment, with experience in contract manufacturing.
• Experience in biologic or cell therapy manufacturing is required.
• Excellent interpersonal, verbal, and written communication skills.
• Experienced in troubleshooting, investigations, problem solving and in negotiating the path forward.
• Strong working knowledge of GMPs and Health Authority standards.
• Ability to manage multiple projects and submissions.
• Comfortable in a fast-paced small company environment.
• Able to influence and negotiate professionally at various levels.

Benefits

• Opportunity to work in a growing company focused on innovative therapies.
• Collaborative and inclusive work environment.
• Support for professional development and continuous improvement.
• Flexible work arrangements including remote options.