Overview

Iovance Biotherapeutics is seeking a Global Product Quality Leader, Director of Product Quality within the Quality Assurance and Product Quality organization to support the Amtagvi commercial program. The ideal candidate will be an experienced Quality professional that will provide global quality oversight of the commercial Amtagvi TIL cell therapy program (clinical / commercial), cross-program initiatives, lifecycle management initiatives that may impact multiple programs, development and oversight of product launch activities and/or Annual Product Quality Reviews, and provide general support and leadership within the Quality Assurance and Product Quality organization. The Director of Product Quality will develop and roll-out global product quality strategies relating to the manufacturing, development, control strategies, method lifecycle, comparability, specifications, stability, product complaints, etc. to minimize product quality risks during product development, technology transfer, and clinical / commercial operations. The candidate will ensure appropriate Quality oversight, strategic input, and compliance when evaluating technical strategies to support the product portfolio and will be a central point of contact between the Quality organization and other cell therapy organizations such as Regulatory Affairs, Process Development, Analytical Development, Manufacturing Sciences & Technology, Operational Quality, Quality Control, and Internal / External Operations. The Director of Product Quality should know and understand the regulatory guiding principles of cell and gene therapy, have experience with clinical and commercial regulatory submissions, and be familiar with compliance of GMP operations in support of advanced therapy operations. This role will be based in Philadelphia Pennsylvania and will report to the Vice President of Quality Assurance and Product Quality.

Job Responsibilities

• Provide global product quality oversight over assigned areas of responsibility and support manufacturing operations including developing and maintaining relationships with other QA, QC, development, analytical, manufacturing sciences and technology, and regulatory functions.
• Supports the overall product quality plan based on Iovance Biotherapeutics annual goals, critical projects, and/or life-cycle support for Product Development Team objectives, regulatory commitments, and process and product monitoring KPIs.
• Provide quality expertise in accordance with global regulatory requirements and internal policies in the creation of Product Characterization, Product Specifications, Method Validation, Stability and Comparability assessments for tech transfers, routine production, suite expansion, etc.
• Supports Global Annual Product Quality Review deliverables (as required) that may include coordinating with leads of contributing chapters and ensure timely and compliant execution of the program
• Act as quality reviewer of CMC sections of Regulatory submissions and response to global agencies queries for various product submissions as required. May author CMC sections or responses to queries, as needed.
• May represent Global Product Quality with global regulatory agencies and during regulatory inspections.
• Represent Quality in the Global CMC and Commercialization teams as needed per development plans.
• Supports the TIL Drug Product Specification Committee relating to program specific topics, and other product quality related cross-functional teams
• Provides supportive quality oversight and guidance during product launch to program teams within Global Product Quality
• Provide strategic guidance and facilitate the timely implementation of global changes with respect to the assigned product. May own global changes and documentation management activities as required.
• Assist in the continuous improvement and lifecycle management of GMP operations, including providing guidance and direction for transitioning from clinical to commercial phase

REQUIRED COMPETENCIES; Knowledge, Skills and Abilities

• Must have a strong Quality mind-set with extensive knowledge of cGMP operations as well as general industry (ICH, USP, etc.) and health authority (FDA, EMA, Health Canada, MHRA, etc.) requirements for advanced cell-therapy programs
• Must be able to interpret problems, make risk-based decisions, and effectively communicate in a productive manner to management and teams.
• Must be able to evaluate technical/scientific attributes and drive compliant technical decisions under minimal supervision.
• Must have strong troubleshooting skills and be able to critically review investigations, interpret results and generate technical conclusions consistent with Quality and global health authority requirements.
• Must be able to effectively operate and deliver in a continuously evolving regulatory and operations landscape.
• Demonstrated Quality leadership through partnership in a matrixed organization is required. Demonstrated ability to work cross-functionally and to develop and maintain strong business partner relationships .
• Proven leadership ability to carry out difficult decisions in a logical, rational manner, and demonstrated ability to work as a senior management team member and to engage and influence team members in a matrixed environment
• Strong project management skills and ability to communicate effectively across matrix functions
• Strong knowledge of global regulations (EU, US) and GxP experience
• Excellent verbal and written communication skills
• Ability to prioritize and balance work from multiple projects in parallel

EDUCATION and EXPERIENCE

• BS/MS or advanced degree (preferred) in relevant Biological Science or similar scientific discipline and 12+ years of experience in Quality in a biotech, pharmaceutical, or biopharmaceutical organization; 4-6 years of experience in a Global Product Quality role is preferred.
• Expertise in GMP compliance, global regulations, and strong understanding of pharmaceutical product development lifecycle are required with specific emphasis on advanced / cellular therapy activities.

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 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.

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