Manager, Quality Assurance Operations

The role

The Manager, Quality Assurance Operations supports day-to-day GMP QA activities for the manufacturing, testing, and release of iPBMCs. This role manages the internal QA Operations team and provides quality support including review and approval of protocols, reports, and batch records.

What you will do

• Ensure day-to-day QA Operations and lot disposition activities are executed as planned.
• Ensure compliance with quality standards, cGMPs, safety regulations, and requirements.
• Interact with Contract Manufacturing Organizations and internal teams for batch release.
• Provide quality direction and contribute to strategic and tactical decisions.
• Perform review and approval of release documentation.
• Author and revise documentation including SOPs, Batch Records, Deviations, and CAPAs.
• Support internal audits and regulatory inspection.
• Act as a subject matter expert and train incoming staff.
• Complete review and approval of laboratory investigations, method validations, and change controls.
• Supervise, mentor, and conduct performance reviews for direct reports.

Required qualifications

• Minimum BA/BS or equivalent in Biological/Physical/Chemical sciences, engineering, or related technical field from an accredited university or college
• Minimum of 8 years of experience in biopharmaceutical based GMP quality operations, including experience in cell culture
• At least 5 years of Lead/Leadership/Supervisory experience in QA roles
• Quality assurance experience and familiarity with regulatory requirements for a cGMP facility
• Experience leading development initiatives, training, coaching, and learning initiatives
• Strong technical writing ability
• Proactive, results oriented, self-starter with demonstrated strong leadership skills
• Working knowledge of Code of Federal Regulations 21 CFR 210/211 and standard GxP best practices and FDA regulations
• Experience with use of an electronic QMS
• Proficient with Microsoft Office Suite, Word, Excel, and Powerpoint
• Ability to remain in a stationary position standing or sitting for prolonged periods
• Ability to perform cleanroom gowning and pass gowning

Nice to have

• preferably within a manufacturing facility

About the company

Iovance Biotherapeutics, Inc. is the global leader in innovating, developing, and delivering tumor infiltrating lymphocyte (TIL) cell therapies for patients with solid tumors. The company operates as an end-to-end cell therapy company with centralized U.S.-based manufacturing.