What are the responsibilities and job description for the Executive Director, Quality Assurance position at Iovance Biotherapeutics, Inc.?
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 Assurance (QA), who has substantial experience leading a Commercial Quality Assurance Operations and Engineering team in a Pharmaceutical, Biotechnology, Advanced Therapy, or Cell Therapy company (preferred experience in advanced therapy or cell therapy). S/he will be a strong and action-oriented leader, who takes ownership and accountability for the oversight of facilities and engineering, manufacturing, investigations, and disposition of all drug products manufactured at Iovance’s Cell Therapy Center (iCTC). The Executive Director will manage and grow a talented QA Operations team to meet the needs of both clinical and commercial operations. S/he will be expected to drive operational improvements to processes, systems, procedures, and ways of working to ensure a robust and agile organization that is compliant and employs appropriate risk-based decision making to meet the needs of a rapidly growing organization. The successful candidate will report the Vice President, Quality Assurance and Product Quality and take on Quality site leadership responsibilities. The candidate will be a strategic thinker who is passionate about working with others in a complex and fast-paced environment.
Essential Functions And Responsibilities
Physical Demands And Activities Required
Work Environment: This job works in a professional office environment and a manufacturing lab setting. Potential exposure to latex, bleach, loud noise, lab equipment hazards, strong odors, and chemical/biochemical is possible. 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.
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.
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 Assurance (QA), who has substantial experience leading a Commercial Quality Assurance Operations and Engineering team in a Pharmaceutical, Biotechnology, Advanced Therapy, or Cell Therapy company (preferred experience in advanced therapy or cell therapy). S/he will be a strong and action-oriented leader, who takes ownership and accountability for the oversight of facilities and engineering, manufacturing, investigations, and disposition of all drug products manufactured at Iovance’s Cell Therapy Center (iCTC). The Executive Director will manage and grow a talented QA Operations team to meet the needs of both clinical and commercial operations. S/he will be expected to drive operational improvements to processes, systems, procedures, and ways of working to ensure a robust and agile organization that is compliant and employs appropriate risk-based decision making to meet the needs of a rapidly growing organization. The successful candidate will report the Vice President, Quality Assurance and Product Quality and take on Quality site leadership responsibilities. The candidate will be a strategic thinker who is passionate about working with others in a complex and fast-paced environment.
Essential Functions And Responsibilities
- As a member of the iCTC SLT (Senior Leadership Team), represent Quality Assurance in helping to guide the iCTC through short- and long-term objectives.
- Oversee QA Operations and QA Engineering at iCTC.
- Ensure that Quality Records (Deviations, Laboratory Investigations, CAPAs, Change Controls, etc.) are adequately written and closed in a timely manner.
- Ensure that all lot disposition activities are efficient, coordinated for each lot, and executed as planned per internal targets and business needs.
- Ensure that reporting functions are adequately organized, supervised, and staffed to meet business needs. Intervene, where necessary, to expedite decision making or to meet target timelines at the iCTC site.
- Provide direction to, and gain alignment across, internal iCTC functions 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 facility is prepared for state, regional, or country authority inspections. Coordinate all authority inspections by ensuring sufficient resources are in-place to respond to information requests, adjudicate compliance discussions, and negotiate any required corrective actions.
- Participate in Quality Management Reviews, Quality Councils, Quarterly Business Reviews to driver performance based on data and metrics.
- Minimum 15 years’ experience in the Pharmaceutical/Biotechnology industry, with extensive leadership experience in commercial QA 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, Europe, Health Canada, UK, Switzerland, and Australia.
- Expert knowledge of FDA and ICH GxP regulations and guidelines in the advanced therapy space.
- Effective negotiation, communication, listening and writing skills. Exceptional ability to develop open, candid, and collaborative working relationships with diverse stakeholders including C-Suite.
- Has the credibility and reputation to attract and retain top talent and have a history of creating high-performing teams.
Physical Demands And Activities Required
- 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.
Work Environment: This job works in a professional office environment and a manufacturing lab setting. Potential exposure to latex, bleach, loud noise, lab equipment hazards, strong odors, and chemical/biochemical is possible. 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.
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.
