Quality Operations Supervisor

5 days ago

Philadelphia, Pennsylvania, United States Iovance Biotherapeutics Inc Full time
Job Description

We are seeking a highly skilled Quality Operations Supervisor to join our team at Iovance Biotherapeutics Inc. This is a unique opportunity to work in a fast-paced environment and contribute to the success of our company.

Key Responsibilities:

  • Supervise and develop direct reports, providing guidance and support to ensure the success of the team.
  • Perform real-time support for escalations, ensuring compliance with GMP and GDP quality initiatives.
  • Schedule and coordinate daily activities, ensuring conformance to the daily schedule.
  • Apply quality compliance theories and principles to address issues of moderate scope, providing guidance on controlled documents and suggesting process improvements.
  • Ensure compliance to cGMPs and facility procedures, interfacing with functional groups to determine events and escalate as necessary.
  • Review batch records and related production documentation, ensuring resolution of all identified issues prior to product disposition.
  • Support the release of drug product and materials during the shift, issuing lot numbers and supporting documentation as needed.
  • Initiate and participate in standard operating procedure (SOP) revisions to improve compliance.
  • Review Quality System records for compliance.

Requirements:

  • Minimum B.S. in biology, biochemistry, bioengineering, or related technical field, or equivalent industry and technical experience.
  • Minimum of 5 years of experience in biopharmaceutical-based GMP aseptic manufacturing, with a minimum of 2 years in a Lead/Leadership/Supervisory Role.
  • Detailed knowledge of Code of Federal Regulations 21 CFR 210/211 and International Council for Harmonization Guidelines governing current Good Manufacturing Practices for Pharmaceuticals.
  • Excellent oral and written communication skills, with the ability to identify and resolve quality issues with others in a proactive, diplomatic, flexible, and constructive manner.
  • Ability to work in a fast-paced environment and changing priorities, with a strong desire to learn and take ownership and accountability.

Work Environment:

This position will work in both an office and a manufacturing setting, with potential exposure to various chemicals/biochemicals, including latex and bleach. The individual must be able to wear appropriate cleanroom attire and all Personal Protective Equipment (PPE), and meet requirements for and be able to wear a half-face respirator.

Physical Demands:

  • Must be able to stand and/or walk 90% (and sit 10%) within your scheduled workday, which may include climbing ladders or steps.
  • Ability to crouch, bend, twist, reach, and perform activities with repetitive motions.
  • Must be able to lift and carry objects weighing up to 45 pounds.

Mental Demands:

  • Clear and conceptual thinking ability; excellent judgment, troubleshooting, problem-solving, analysis, and discretion.
  • Ability to handle work-related stress, handle multiple priorities simultaneously, and meet deadlines.

Equal Employment Opportunity:

Iovance Biotherapeutics Inc is an equal-opportunity employer, committed to cultivating and offering a diverse and inclusive work environment. We welcome applications from qualified candidates without regard to an individual's race, color, religion, sex, pregnancy, national origin, age, physical and mental disability, marital status, sexual orientation, gender identity, gender expression, genetic information, military and veteran status, and any other characteristic protected by applicable law.

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