Manager, Quality Assurance Operations

Overview

Iovance Biotherapeutics is a growing company focused on the development and commercialization of immunotherapies based on TIL (Tumor Infiltrating Lymphocytes). The PIP (Person-in-Plant) is a newly created position that will be integral to providing QA (Quality Assurance) oversight of a CMO (Contract Manufacturing Organization). The position will be the main QA point-of-contact and will help co-ordinate daily quality-related operations between Iovance and the CMO.

The position is in Philadelphia and will report to the Director of Quality Assurance Operations.

Essential Functions and Responsibilities

• Represent Iovance QA by working on-site at the CMO for up to 5 days per week.
• Establish direct lines of communication with the CMO QA and QC functions.
• Optimize and help drive decision making.
• Ensure knowledge and information between the CMO and Iovance are shared in a timely manner.
• Identify, propose, and implement procedural changes to improve controls and product quality.
• Continuously evaluate CMO performance. Identify and implement corrective actions as needed.
• Lead or participate in investigations for nonconforming events.
• Evaluate if planned changes are fully implemented.
• Support batch record review and release.
• Evaluate procedures and practices to ensure inspections readiness.
• Report on CMO performance for overall site metrics, key issues at Iovance’s Quality Review meetings.
• Provide support for Iovance audits of CMO.
• Other duties as assigned.

Basic Qualifications

• BS degree in life sciences. Advanced degree a plus.
• At least 10 years of Quality experience in a GMP environment, with experience in contract manufacturing.
• Experience in biologic or cell therapy manufacturing is required
• Excellent interpersonal, verbal and written communication skills are essential in this collaborative position.
• Experienced in troubleshooting, investigations, problem solving and in negotiating the path forward with multiple functions.
• Strong working knowledge of GMPs and Health Authority standards and expectations in both the US and Europe.
• Ability to simultaneously manage multiple projects and submissions.
• Ability to follow through on all activities to ensure projects are completed as planned.
• Comfortable in a fast-paced small company environment and able to adjust workload based upon changing priorities.
• Able to influence and negotiate professionally at various levels within the project team and with external partners while maintaining positive working relationships.

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

• Clarity of vision at near and mid-range, depth perception, ability to identify and distinguish colors.
• Must be able to wear appropriate clean room attire and all Personal Protective Equipment (PPE), i.e. scrubs, gowning coverall, masks, gloves, etc.
• Able to stand and/or walk 90% (and sit 10%) of a full day which may include climbing ladders or steps.
• Ability to crouch, bend, twist, reach, and perform activities with repetitive motions.
• Ability to lift 20 lbs.

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 deadline

Work Environment:

• Able to work in cleanroom with biohazards, human blood components, chemicals, and variable noise levels.
• Works in production environment with exposure to latex and bleach.  Potential exposure to noise and equipment hazards and strong odors. 
• This position will work in both an office and a manufacturing lab setting.
• When in the lab, must be able to work in Lab setting with various chemical/biochemical exposures, including latex and bleach.

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.

Iovance 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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