Associate Director - Product Quality

3 days ago

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Iovance Biotherapeutics, Inc.

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Immuno Oncology • Autologous Cell Therapy • Tumor Infiltrating Lymphocytes (TIL) • Novel Cancer Immunotherapies • cell therapy

501 - 1000 employees

Founded 2014

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

Description

• 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. • May act as quality reviewer of CMC sections of regulatory submissions and response to questions from global health authorities as required. • May author CMC sections or responses to questions, 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 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.

Requirements

• 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.