Director, Global Product Quality Lead, Cell Therapy

The Director, Cell Therapy Quality Lead will:

• Be recognized as a technical and industry expert across multiple core disciplines and/or technology platforms.​ Drives strategy across multiple technical teams and provides quality oversight and support for manufacturing operations including developing and maintaining relationships with site QA, QC, analytical and process development, manufacturing sciences and technology, and regulatory affairs functions.​

• Actively contribute to the strategic direction of multiple disciplines and provide diverse scientific and strategic input for meeting functional objectives.​

• Partner across Global Product Quality, Analytical Sciences and Technology, CT Development, CT Operations, and CT Regulatory CMC to define and deliver product quality strategies that comply with internal and external quality standards and regulatory requirements.

• Makes complex tactical and strategic decisions that have impact across the GPS enterprise. Serves as a delegate for the Global PQL in CMC/TCT meetings, Development team meetings, and general cell therapy governance meetings.

• Translates industry trends and innovative technology or strategy into business opportunities. May anticipate future trends.​

• Provides technical quality expertise and compliance oversight in accordance with global regulatory requirements and internal policies in support of commercial development efforts and life-cycle management activities.

• Supports Global Annual Product Quality Review deliverables for the product that include coordinating with leads of contributing chapters and ensure timely and compliant execution of the program

• Coordinates product specific presentations to the Product Quality Review Board / Product Specification Committee and other product quality related cross-functional teams

• Serves as QA reviewer / approver for development reports, product specifications, and product labeling 

• Provide strategic guidance and facilitate the timely implementation of global changes with respect to the product.  Owns 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

• Provide global product quality oversight over assigned areas of responsibility and support manufacturing operations including developing and maintaining relationships with partner organizations.

• Provide quality expertise in accordance with global regulatory requirements and internal policies in support of Product Characterization, Product Specifications, Method Validation, Stability and Comparability assessments for manufacturing and site changes.

• Perform Quality review of CMC sections of regulatory submissions and responses. May author CMC sections or responses to queries, as needed.

Professional experience and qualifications

• Master’s or PhD degree in Biochemistry, Immunology, Molecular Biology, Chemistry, Biology or corresponding engineering discipline preferred

• At least 10+ years of experience in cell therapy, pharmaceutical and/or biotechnology fields in Manufacturing Operations or Quality roles

Knowledge and Skills:

The Dir. CT-PQL, is preferred to have experience in the development of quality strategies to ensure product quality throughout the lifecycle. The Dir. CT-PQL is a motivated, engaged, solutions-driven, and strategic role who supports the CT-GPQL in the advancement of quality readiness. In particular, the Dir. CT-PQL has:

• Expertise in GMP compliance, global regulations, and strong understanding of pharmaceutical product development lifecycle, with specific emphasis on gene delivery and/or cell therapy preferred.

• Experience authoring, reviewing, and representing Quality in support of both clinical and commercial regulatory submissions across multiple domestic and international jurisdictions.

• Working background in Biologics, Gene Delivery, or Cell Therapy Manufacturing

• Demonstrated ability to work cross-functionally and demonstrate decision making and problem-solving capabilities relative to Quality, compliance, technical considerations, and regulatory requirements

• Experience participating in interactions with global regulatory agencies and in the

• Strategic thinker who sees the bigger picture and possesses high business acumen; understands how the parts impact the whole (end to end enterprise) and makes the best decisions for the whole

• Capability negotiation experience to influence others in a matrix environment

• Strong collaboration, delegation and interpersonal communications skills to enable sharing critical information with project team and management.

• Demonstrated analytical and logical skills with a focus on fact-based decision making.

If you want to advance your career and give new hope to patients, there’s no better place than here with our Cell Therapy team. Full of incredible and dedicated team members, those working on CAR-T and other forms of Cell Therapy are transforming patients’ lives through science. From studying individualized cell lines to making brand new discoveries, this bold and personal discipline allows you to grow your career while making a lasting impact on the field of medicine. Join us today.