Manager, Quality Assurance Operations

Iovance Biotherapeutics • Philadelphia, PA

8d • Onsite

About The Position

The Manager, Quality Assurance (QA), IOVA-A QA Operations supports day-to-day GMP QA activities for the manufacturing, testing, and release of iPBMCs. The role provides quality oversight, including review and approval of qualification and validation protocols and reports, batch record review, and release of manufactured lots. The Manager works collaboratively with internal teams and contract manufacturing organizations in a complex, fast-paced environment and manages the internal QA Operations team. The position is on-site and combines office and manufacturing-setting work.

The Manager provides operational quality direction, helps ensure efficient and compliant operations, and supports timely batch release. The role also serves as a subject matter expert, trains and develops staff, oversees quality records and documentation, supports audits and inspections, and leads continuous-improvement efforts. The position requires strong communication, organization, technical writing, ownership, and the ability to handle changing priorities and challenging problems.

Requirements

• Minimum BA/BS degree or equivalent in biological, physical, or chemical sciences, engineering, or a related technical field from an accredited college or university.
• Minimum 8 years of experience in biopharmaceutical GMP quality operations, including cell culture experience.
• At least 5 years of lead, leadership, or supervisory experience in QA roles.
• Significant QA experience and comprehensive understanding of QA processes and regulatory requirements for a cGMP facility.
• Experience leading development initiatives, such as training, coaching, and learning initiatives.
• Ability to mentor and provide best practices and support to teams across the Quality Assurance department.
• Clear and effective collaboration, communication, listening, and writing skills; strong technical writing ability.
• Proactive, results-oriented self-starter with demonstrated leadership skills and experience in a complex manufacturing environment.
• Quality mindset and working knowledge of 21 CFR 210/211, standard GxP best practices, and FDA regulations.
• Ability to work under limited supervision and handle problems of a difficult nature.
• Experience using an electronic QMS.
• Proficiency with Microsoft Office, including Word, Excel, and PowerPoint.
• Ability to remain standing or seated in a stationary position for prolonged periods.
• Ability to move around an office and exert up to 10 pounds of force occasionally, or negligible force frequently or constantly, to move objects.
• Visual acuity for preparing and analyzing data and figures, viewing a computer screen, and extensive reading.
• Ability to perform cleanroom gowning and pass gowning.
• Ability to perform repetitive wrist, hand, and/or finger motions.
• Ability to communicate with others to exchange information.
• Clear conceptual thinking, sound judgment, troubleshooting, problem-solving, analysis, and discretion; ability to handle work-related stress, manage multiple priorities, and meet deadlines.

Nice To Haves

• Leadership or supervisory experience in QA, preferably within a manufacturing facility.

Responsibilities

• Ensure day-to-day QA Operations activities and lot disposition are efficient, coordinated, and executed as planned.
• Ensure operations comply with quality standards, cGMPs, safety regulations, and documented requirements.
• Work with contract manufacturing organizations and internal teams to support efficient, timely batch release.
• Contribute to strategic and tactical decisions based on quality principles and available data; provide quality direction and build cross-functional alignment during problem solving.
• Seek and support approaches, practices, and processes that improve operational efficiency and effectiveness.
• Review and approve release documentation.
• Track and communicate completion of standard work and related hurdles.
• Author and revise documentation, including SOPs, batch records, deviations, and CAPAs.
• Support internal audits and regulatory inspections.
• Act as a subject matter expert and train incoming staff.
• Review and approve laboratory investigations, deviation investigations, method validations, change controls, and CAPAs accurately and promptly.
• Ensure quality records, including deviations, laboratory investigations, CAPAs, and change controls, are adequately written and closed on time.
• Supervise, develop, mentor, and coach direct reports and staff to foster continuous improvement and operational excellence.
• Organize and supervise QA staff and intervene as needed to expedite decisions or meet timelines.
• Maintain training in QA processes to provide hands-on assistance when necessary.
• Establish objectives, conduct performance reviews, monitor progress, and provide timely feedback to management.
• Identify and resolve quality issues proactively, diplomatically, flexibly, and constructively with others.
• Generate and monitor departmental performance metrics.
• Manage multiple changing priorities and aggressive timelines while maintaining productivity, ownership, and accountability.
• Adhere to Iovance Biotherapeutics' core values, policies, procedures, and business ethics.
• Perform other duties as assigned.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager