Executive Director, Quality Control Operations

Overview
Iovance Biotherapeutics is a global leader in innovating, developing, and delivering 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.

We are a patient-centric, collaborative organization that is driven to change the way cancer is treated. We are agile in our thinking and strive for excellence and innovation while acting with high integrity to create value for all stakeholders.

Iovance is seeking an Executive Director, Quality Control Operations, who has substantial experience leading Commercial Quality Control in Pharmaceutical or Biotechnology companies. S/he will be a strong and action-oriented leader, who takes ownership and accountability for the testing and release of all drug products and iPBMCs manufactured at Iovance's Cell Therapy Center (iCTC) and the Iovance at American Red Cross (IOVA-A) site. The Executive Director will manage and grow a talented QC Operations team that is responsible for performing environmental monitoring, in-process, final release, and stability testing and release of our iPBMCs, clinical, and commercial drug product at both iCTC and IOVA-A. This role will be accountable for QC method transfer, qualification, and validation. In addition, this role will be accountable for lot release and support activities, including but not limited to, quality records management, document issuance, sample management, QC electronic systems, and training. The successful candidate will report the Vice President, Quality Control and serve on the site senior leadership team. The candidate will be a strategic thinker who is passionate about working with others in complex and fast-paced environment.

Essential Functions and Responsibilities

• As a member of the iCTC SLT (Senior Leadership Team), represent Quality Control in helping to guide the iCTC through short- and long-term objectives.
• Ensure that all lot testing and release activities are efficient, coordinated for each lot, and executed as planned.
• Ensure that QC quality record requirements and targets are met and tracked.
• Ensure that reporting functions are adequately organized, supervised, and staffed. Intervene, where necessary, to expedite decision making or to meet target timelines.
• Ensure successful method transfer, qualification, validation, and training for all Iovance products.
• Provide technical direction to, and gain alignment across, functions who are problem solving. Contribute to strategic and tactical decisions based on sound Quality principles and available data.
• Cultivate a culture of quality and shared accountability throughout the organization to help ensure compliance with applicable regulations, guidelines, corporate standards, policies and procedures.
• Drive corporate and department objectives to completion through strong collaboration with colleagues, other internal functions, and vendors.
• Ensure that the iCTC and IOVA-A facilities are prepared for state, regional, or country authority inspections.
• Participate in Quality Management Reviews, Quality Councils, Quarterly Business Reviews to driver performance based on data and metrics.

Required Education, Skills, and Knowledge

• Minimum 15 years' experience in the Pharmaceutical/Biotechnology industry, with extensive leadership experience in commercial QC roles. Cell therapy experience strongly preferred.
• Confident, independent, self-starter, who is proactive, and results oriented.
• Experienced overseeing US and EU commercial manufacturing.
• Expert knowledge of Health Authority expectations and industry practices in the US and Europe.
• Expert knowledge of FDA and ICH GxP regulations and guidelines.
• Effective negotiation, communication, listening and writing skills. Exceptional ability to develop open, candid, and collaborative working relationships with diverse stakeholders including C-Suite.
• Strong scientific and technical expertise with the ability to analyze a wide range of complex data
• Has the credibility and reputation to attract and retain top talent and have a history of creating high-performing teams.

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:

• Must be able to wear appropriate clean room attire and all Personal Protective Equipment (PPE), i.e. scrubs, gowning coverall, masks, gloves, etc.
• Must meet requirements for and be able to wear a half-face respirator.
• Able to stand and/or walk 90% (and sit 10%) of a 10-hr day which may include climbing ladders or steps.
• Must be able to use near vision to view samples at close range
• Able to crouch, bend, twist, reach, and perform activities with repetitive motions.
• Must be able to lift and carry objects weighing 45 pounds.

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:

• 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.
• Able to work in cleanroom with biohazards, human blood components, and chemicals.
• Potential exposure to noise and equipment hazards and strong odors.

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.

By voluntarily providing information and clicking "Submit Application", you explicitly consent to the collection and use of your personal information for the purposes described above and in our Candidate Privacy Notice.

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