Director, Product Quality Lead

Overview

Iovance Biotherapeutics is seeking a Product Quality Leader (PQL) responsible for providing strategic and operational leadership across the product lifecycle by representing the Quality organization on product development and CMC teams and influencing implementation of compliant, scientifically-driven, risk-based, and phase-appropriate solutions and strategies for Iovance’s clinical and commercial biologics programs.

The ideal candidate will have a strong CMC background with experience in technical development and lifecycle management of biologics products including upstream and downstream processing, technology transfer, and analytical methods, have authored / reviewed regulatory filings, have broad and deep experience employing a holistic and quality mindset toward product development, and experience navigating Quality systems.

The PQL will develop and implement global product quality strategies relating to process development lifecycle, manufacturing, supply, total integrated control strategy, analytical method lifecycle, validation, 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 cross-functional organizations and stakeholders including Process Development, Manufacturing Sciences and Technology, Analytical Development, Analytical Sciences and Technology, Regulatory-CMC, Quality Operations, Quality Assurance, and Quality Control.  The PQL should know and understand regulatory guiding principles of biologics, have experience with clinical and commercial regulatory submissions, and be familiar with compliance of GMP operations in support of advanced therapy operations. The PQL will ensure appropriate Quality oversight, strategic input, and compliance when evaluating technical strategies to support the product portfolio and will provide global quality oversight to cross-program development and lifecycle management initiatives that may impact multiple programs as well as general support and leadership within the Quality Assurance and Product Quality organization. 

Essential Functions and Responsibilities

·       Provide global product quality oversight over assigned areas of responsibility and support manufacturing operations including developing and maintaining relationships with cross-functional team leaders, QA and QC, process development, manufacturing sciences and technology, analytical development, analytical sciences and technology, regulatory, and management.

·       Supports the overall product quality plan for assigned programs and projects based on Iovance Biotherapeutics annual goals, critical projects, and/or lifecycle support for Product Development and CMC team objectives, regulatory commitments, and process and product monitoring KPIs.

·       Lead a cross-functional Product Quality Team to ensure awareness of product development activities and milestones, drive strategic and operational alignment within the Quality function, develop, prioritize, and manage lifecycle management initiatives, and monitor process and analytical method performance to ensure the manufacturing process and analytical methods remain in a state of control.

·       Assists and may provide Quality expertise in accordance with global regulatory requirements and internal policies in the creation of product characterization, product specifications, validation studies, stability studies, and comparability assessments for tech transfers, routine production, capacity expansion, etc.

·       Act as Quality reviewer of CMC sections of regulatory submissions and responses to questions from global health authorities.  May author CMC sections or responses to questions, as needed.

·       Represent Quality in interactions with global regulatory agencies and during regulatory inspections.

·       Represent Quality in global CMC and commercialization teams as needed per development plans.

·       Supports the specification review board relating to program-specific topics and other cross-functional teams.

·       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.

·       Perform similar duties in support of development of tumor infiltrating lymphocyte (TIL) cell therapy programs, as needed.

Required Education, Skills, and Knowledge

·       BS, MS, or Ph.D in relevant Biological Science or similar scientific discipline with at least 12 (BS), 10 (MS), or 7 (Ph.D.) years of experience in CMC and/or Quality in a biotech or biopharmaceutical organization.

·       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 biologics.

·       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.

·       Expertise in GMP compliance, global regulations, and strong understanding of biopharmaceutical product development lifecycle is required.

·       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.

Preferred Education, Skills, and Knowledge

·       1-3 years of experience as a Product Quality Lead.

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 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.

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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