Associate Director, Product Quality Operations and Stability
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Overview
Iovance Biotherapeutics is seeking an Associate Director of Product Quality Operations and Stability within the Quality Assurance and Product Quality organization. The ideal candidate will be an experienced Quality professional that will individually lead and oversee product specification management activities (documentation management, change control, etc.), stability program management (strategy, protocol design, developing improving stability standards, protocols, reports), and ownership of applicable standards and procedures relating to specifications, stability, and annual product reviews impacting all global internal and external sites. The candidate will serve as a change agent / influencer of global product teams and site Quality teams. The primary responsibility will be to improve the maturity of the Quality systems and programs owned by Product Quality. The candidate should drive alignment across commercial and clinical programs relating to system improvements, common practices, and develop common stability strategies, practices, workflows, and implementation practices. The scope of the Quality systems includes global specification management, stability programs, annual product reviews, and others as required. The scope of the stability programs will include all aspects related to TIL cell therapy drug product, drug product intermediates, and development programs where applicable cell banks, plasmids, and vector studies may be required.
The candidate will provide significant support and contributions to the TIL Cell Therapy Product Quality Teams by developing cross-program / cross-site stability strategies, specification management based on health authority feedback and will support (author/review) both clinical and commercial cell therapy regulatory filings as needed. The Associate Director of Product Quality Operations and Stability and should utilize their leadership and technical skills to shape and drive global initiatives relating to TIL cell therapy and stability to provide significant contribution to the daily operations of the Quality Assurance and Product Quality organization. The position will be responsible for ensuring compliance with the current and prospective global regulatory requirements and should be aware of and adopt effective and efficient industry standard practices.
REQUIRED COMPETENCIES; Knowledge, Skills and Abilities
Physical Demands and Activities Required (This would need to be adjusted by HRBP depending on the position and needs using the assessment form)
Work Environment
This job operates in a professional workplace or remote office environment and requires standard office equipment and keyboards. Employees who work remotely are expected to maintain their workspace and environment safely and free from safety hazards.
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 [email protected].
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 seeking an Associate Director of Product Quality Operations and Stability within the Quality Assurance and Product Quality organization. The ideal candidate will be an experienced Quality professional that will individually lead and oversee product specification management activities (documentation management, change control, etc.), stability program management (strategy, protocol design, developing improving stability standards, protocols, reports), and ownership of applicable standards and procedures relating to specifications, stability, and annual product reviews impacting all global internal and external sites. The candidate will serve as a change agent / influencer of global product teams and site Quality teams. The primary responsibility will be to improve the maturity of the Quality systems and programs owned by Product Quality. The candidate should drive alignment across commercial and clinical programs relating to system improvements, common practices, and develop common stability strategies, practices, workflows, and implementation practices. The scope of the Quality systems includes global specification management, stability programs, annual product reviews, and others as required. The scope of the stability programs will include all aspects related to TIL cell therapy drug product, drug product intermediates, and development programs where applicable cell banks, plasmids, and vector studies may be required.
The candidate will provide significant support and contributions to the TIL Cell Therapy Product Quality Teams by developing cross-program / cross-site stability strategies, specification management based on health authority feedback and will support (author/review) both clinical and commercial cell therapy regulatory filings as needed. The Associate Director of Product Quality Operations and Stability and should utilize their leadership and technical skills to shape and drive global initiatives relating to TIL cell therapy and stability to provide significant contribution to the daily operations of the Quality Assurance and Product Quality organization. The position will be responsible for ensuring compliance with the current and prospective global regulatory requirements and should be aware of and adopt effective and efficient industry standard practices.
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
- Knowledge of risk management principles and their implementation into routine production and/or testing strategies.
- Must be able to interpret problems 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 requirements.
- Strong technical writing skills
- Must manage problems of diverse scope and demonstrate ability to translate complex issues in a concise manner.
- Must be able to effectively operate and deliver in a continuously evolving regulatory and operations landscape.
- Collaborate within Quality, internal functional areas, and CMOs to generate, review and approve documentation, including: change controls, deviations, CAPAs and OOS/OOT investigation reports
- Develops, implements and continuously improves Quality Operations processes pertaining to quality oversight of stability studies, ensuring quality related items are tracked, monitored and resolved in a timely manner
- Oversee and support cross-functional laboratory investigations related to stability and external laboratory operations
- Manage the operation of Stability programs across a multi-product portfolio, managing stability protocols and reports, coordination, review, reporting of stability test data for TIL cell therapy drug products (internal reports, clinical / commercial regulatory filings).
- Performs document management responsibilities in support of viral vector, TIL cell therapy intermediates, and TIL cell therapy drug product specifications. Supports the specification committee tactical execution as needed.
- Develops, monitors and reports on Product Quality functional responsibility and Key Performance Indicators including creation of dashboards and providing updates to management/leadership teams.
- Identifies quality issues and effectively and proactively communicates and resolves them in a diplomatic, flexible, and constructive manner
- Contribute to the preparation of CMC sections for clinical regulatory filings, MAA, and BLA
- Bachelors’ and/or Masters’ degree in scientific discipline with a technical understanding of biopharmaceutical production and understanding of cell therapy and drug product development and manufacturing
- Minimum of 10+ years of biologics industry experience in a technical role(s) supporting programs in pre-clinical phases through commercial, with at least one or more role (5+ years) in Quality (QA, QC and/or Compliance)
- 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
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.
Work Environment
This job operates in a professional workplace or remote office environment and requires standard office equipment and keyboards. Employees who work remotely are expected to maintain their workspace and environment safely and free from safety hazards.
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 [email protected].
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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