Manager, Quality Assurance Operations

Iovance Biotherapeutics • Philadelphia, PA

7d • Onsite

About The Position

The Manager, Quality Assurance (QA), IOVA-A QA Ops supports day-to-day GMP QA Operations activities for manufacturing, testing, and release of iPBMCs in a GMP-compliant manner. This on-site role manages the internal QA Operations team and provides quality support, including review and approval of qualification and validation protocols and reports, batch record review, and release of manufactured lots. The successful candidate is collaborative, organized, flexible, accountable, and able to communicate effectively in a complex, fast-paced environment.

The position oversees efficient QA Operations and lot disposition, supports timely batch release in coordination with Contract Manufacturing Organizations and internal teams, provides quality direction across functions, and contributes to operational improvements and decisions based on quality principles and available data. The Manager reviews and approves release documentation and quality records, authors and revises procedures and records, supports audits and regulatory inspections, and serves as a subject matter expert who trains staff.

The Manager also supervises and develops direct reports, establishes objectives, conducts performance reviews, and provides coaching and feedback. The role requires hands-on support when necessary, effective management of changing priorities and timelines, and a proactive, constructive approach to resolving quality issues. Work takes place in office and manufacturing settings, including potential lab exposure to chemicals and other manufacturing hazards.

Requirements

• Bachelor’s degree or equivalent in biological, physical, or chemical sciences, engineering, or a related technical field from an accredited university or college.
• At least 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; manufacturing-facility experience is preferred.
• Significant QA experience and a thorough understanding of regulatory requirements for a cGMP facility.
• Working knowledge of 21 CFR 210/211, GxP best practices, and FDA regulations.
• Experience with electronic quality management systems (eQMS).
• Strong technical writing ability and proficiency in Microsoft Office, including Word, Excel, and PowerPoint.
• Clear and effective collaboration, communication, listening, and writing skills.
• Demonstrated leadership in a complex manufacturing environment; proactive, results-oriented, and self-starting approach.
• Ability to mentor and provide best practices and support to teams across the QA department.
• Ability to work under limited supervision and handle difficult problems.
• Ability to manage multiple priorities and meet deadlines.
• Ability to remain standing or seated in a stationary position for prolonged periods.
• Ability to move around an office and occasionally exert up to 10 pounds of force, or frequently or constantly exert negligible force, 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 requirements.
• Ability to perform repetitive wrist, hand, and finger movements and communicate with others to exchange information.

Nice To Haves

• At least 5 years of QA leadership or supervisory experience, preferably within a manufacturing facility.
• Experience leading development initiatives such as training, coaching, and learning initiatives.
• Experience with cell culture in biopharmaceutical GMP quality operations.

Responsibilities

• Ensure day-to-day QA Operations activities and lot disposition are efficient, coordinated, and completed as planned.
• Ensure operations comply with quality standards, cGMPs, safety regulations, and documented requirements.
• Coordinate with Contract Manufacturing Organizations and internal teams to support efficient, timely batch release.
• Contribute to strategic and tactical decisions using sound Quality principles and available data.
• Provide quality direction and build alignment across functions during problem solving.
• Identify and support approaches and processes that improve operational efficiency and effectiveness.
• Review and approve release documentation, qualification and validation protocols and reports, batch records, and other applicable documentation.
• Track and communicate standard work completion and obstacles to appropriate stakeholders.
• Author and revise documentation, including SOPs, batch records, deviations, and CAPAs.
• Support internal audits and regulatory inspections.
• Serve 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 are adequately written and closed in a timely manner.
• Supervise and develop direct reports, and mentor and coach staff to promote continuous improvement and operational excellence.
• Organize and supervise QA staff, intervening when needed to expedite decisions or meet target timelines.
• Maintain sufficient training in QA processes to provide hands-on assistance when necessary.
• Establish objectives, conduct performance reviews, monitor progress, and provide timely feedback to management and staff.
• Identify and resolve quality issues proactively, diplomatically, flexibly, and constructively.
• Generate and monitor departmental performance metrics.
• Manage multiple changing priorities and aggressive timelines while maintaining productivity and accountability.
• Adhere to Iovance Biotherapeutics core values, policies, procedures, and business ethics, and perform other duties as assigned.

What This Job Offers

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