Manager, Quality Assurance Operations - Day Shift

Overview

Iovance Biotherapeutics is a global leader in innovation, development, and delivery of tumor infiltrating lymphocyte (TIL) therapy for people with cancer. We are pioneering a transformational approach to treating cancer by harnessing the ability of the human immune system to recognize and attack diverse cancer cells in each patient.

Our recent launch of AMTAGVI and associated growth has led to the creation of a new position. The Manager, Quality Assurance (QA) will be a key role that ensures adequate Quality oversight for the manufacture and disposition of a critical raw manufactured in-house. The Manager will be a strong and action-oriented leader who is capable of leading QA teams. The role will report to the Director, QA.

The Manager of QA Operations has worked in an aseptic manufacturing facility and is familiar with cleanroom manufacturing requirements. S/he will manage a QA Operations team that provides QA oversight for Iovance’s in-house iPBMC (irradiated peripheral blood mononuclear cells) manufacturing activities at 700 Spring Garden St, Philadelphia, PA., which is co-located at the American Red Cross Penn Jersey Region. iPMBC are a critical raw material used in the company's TIL drug product manufacturing process.

This individual is responsible for supporting day-to-day GMP QA Operations activities that support manufacturing, testing and release of iPBMCs in a GTP and GMP compliant manner. The individual is collaborative, organized, innovative, flexible, with a strong desire to learn and take ownership and accountability.

The Manager provides overall Quality Assurance support including and but not limited to review and approval of room qualification protocols/reports, line clearance, ongoing environmental monitoring/ cleaning documentation, APV's / PPQ's, routine production, batch record review and release of iPBMCs. The successful candidate will work on-site and will manage the internal QA Operations team. The Manager is an effective communicator and is comfortable working in a complex and fast-paced environment.

This is a day-shift position, Monday - Friday, normal business hours.

Essential Functions And Responsibilities

• Ensure that lot disposition activities are efficient, coordinated, and executed as planned.
• Ensure that QA staff are adequately organized, supervised, and staffed. Intervene, where necessary, to expedite decision making or to meet target timelines.
• Ensure that Quality Records (e.g., Deviations, CAPA) are adequately written.
• Contribute to strategic and tactical decisions based on sound Quality principles and available data. Provide technical direction to, and gain alignment across, functions who are problem solving.
• Help drive facility objectives to completion through strong collaboration with colleagues.
• Perform other duties as assigned
  
  

Required Education, Skills, And Knowledge

• BA/BS or equivalent in Biological/Physical/Chemical sciences, engineering, or equivalent focus of study from an accredited university or college with 10 years of relevant experience
• Leadership experience in a QA role(s) preferably within a manufacturing facility.
• Experience in GMPs and cleanroom manufacturing is a must. Cell therapy experience a plus.
• Confident, independent, self-starter, who is proactive and results oriented.
• Effective negotiation, communication, listening and writing skills.
• Good working knowledge of Code of Federal Regulations 21 CFR 210/211
• Ability to identify and resolve quality issues with others in a proactive, diplomatic, flexible, and constructive manner
• Must be comfortable in a fast-paced environment and changing priorities
• Experience with use of an electronic QMS
• Proficient with Microsoft Office Suite, Word, Excel, and PowerPoint
  
  

The physical demands described here represent those that an employee must meet to perform the essential functions of this job successfully. Reasonable accommodations may be made upon request to enable individuals to perform essential functions. Please contact Human Resources to request an accommodation.

Physical Demands and Activities Required (This would need to be adjusted by HRBP depending on the position and needs using the assessment form)

• Must be able to remain in a stationary position standing or sitting for prolonged periods of time.
• Must be able to move about inside an office and exert up to 10 pounds of force occasionally or a negligible amount of force frequently or constantly to lift, carry, push, pull, or otherwise move objects
• Must have visual acuity to perform activities such as: preparing and analyzing data and figures, viewing a computer screen, and extensive reading
• This position requires repetitive motion, substantial movements (motions) of the wrist, hands, and/or fingers
• Must be able to communicate with others to exchange information
  
  

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

Work Environment

This job operates in a professional or remote office environment and requires operating standard office equipment and keyboards.

The statements contained in this document are intended to describe the general nature and level of work being performed by a colleague assigned to this description. They are not intended to constitute a comprehensive list of functions, duties, or local variances. Management retains the discretion to add or to change the duties of the position at any time.

lovance is committed to cultivating and offering a diverse and inclusive work environment. As an equal­ opportunity employer, our employees and applicants will be considered 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. If you need assistance or accommodation to apply to one of our opportunities, please contact careers@iovance.com.

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