Manager, CAPAs, Deviations, and Change Control

Iovance Biotherapeutics - Philadelphia, PA

Full-time - Manager

Philadelphia, PA

Chemical Manufacturing

About the position

Iovance is seeking a manager with substantial experience in CAPAs, Deviations, and Change Control management within the Pharmaceutical and/or Biotechnology industry. This role is responsible for supporting the implementation and management of these programs to ensure GMP compliance according to regulations and company policies. The ideal candidate will be innovative, self-sufficient, and accountable for quality, overseeing quality systems and participating in audits and inspections. A growth-oriented mindset and the ability to work in fast-paced environments are essential.

Responsibilities

• Administer and manage the electronic Quality Management System (eQMS) for change control, deviation, and CAPA processes.
• Establish and enforce quality standards for deviation, CAPA, and change control records at Iovance.
• Train eQMS system users and provide user support.
• Track eQMS workflows to facilitate timely closure.
• Attend cross-functional meetings to provide quality systems expertise.
• Assist and guide functional areas in deviation investigations and root cause determination.
• Facilitate Change Control Review Board.
• Oversee the execution and completion of corrective actions or effectiveness check activities.
• Author or revise SOPs and work instructions to ensure compliance standards are met.
• Author and deliver training to quality system users as needed.
• Identify, drive, and collaborate on continuous improvement projects.
• Develop and track key quality metrics and KPIs for monitoring quality systems performance.
• Present metrics at regular Quality meetings, including Quality Management Review.
• Maintain updated knowledge of GxP landscape, regulations, and guidelines.
• Participate in cross-functional process improvement teams as needed.
• Support audit and inspection readiness at the manufacturing facility.
• Perform or support GxP audits of internal departments and external contract service providers as needed.
• Manage direct reports through regular 1:1's, performance appraisals, and guidance.

Requirements

• BA/BS or equivalent in Biological/Physical/Chemical sciences, engineering, or equivalent focus of study from an accredited university or college with 8+ years of relevant experience.
• Detailed knowledge of Code of Federal Regulations and International Council for Harmonization Guidelines governing current Good Manufacturing Practices for Pharmaceuticals.
• Experience with an electronic QMS, MasterControl preferred.
• Excellent oral and written communication skills.
• Ability to identify and resolve quality issues proactively and diplomatically.
• Comfortable in a fast-paced environment with minimal direction and changing priorities.
• Proficient with Microsoft Office Suite, including Word, Excel, and PowerPoint.