Cullinan Therapeutics, Inc.(Nasdaq: CGEM) is a biopharmaceutical company dedicated to creating new standards of care for patients.
We have strategically built a diversified portfolio of clinical-stage assets that inhibit key drivers of disease or harness the immune system to eliminate diseased cells in both oncology and autoimmune disease. Our portfolio encompasses a wide range of modalities, each with the potential to be best and/or first in class.
Anchored in a deep understanding of oncology, immunology, and translational medicine, we create differentiated ideas, identify the most appropriate targets, and select the optimal modality to develop transformative therapeutics across a wide variety of cancer and autoimmune indications.
We push conventional boundaries from candidate selection to differentiated therapeutic, applying rigorous go/no go criteria at each stage of development to fast-track only the most promising molecules to the clinic and, ultimately, commercialization.
With deep scientific expertise, our teams exercise creativity and urgency to deliver on our promise to bring new therapeutic solutions to patients.
Summary:
We are currently seeking a dynamic, highly motivated, and experienced individual for the position of Director/Sr. Director, Global GMP Quality Assurance. The Director/Sr. Director, Global GMG Quality Assurance will act as the Head of GMP QA and has overall responsibility for establishing QMP QA quality objectives, managing the GMP QA team, and representing GMP Quality on product program teams. This role interprets GMP and GDP regulations, determines quality requirements, and works closely with internal cross-functional teams and external partners to execute quality strategy to support overall product quality. This role fosters a quality culture and mindset for inspection readiness and continuous improvement, through Cullinan and it's global contract manufacturing business partners. The Director Sr. Director regularly provides quality updates and metrics in department, project, and quality management review meetings. The Director/Sr. Director, Global GMP Quality has multiple direct reports, is a member of the Quality Assurance Leadership Team (QALT) and reports to the Vice President, Quality Assurance.
Position Responsibilities:

• Provide Quality leadership on planning and execution of the GMP QA Strategy
• Ensure and deliver Quality and Compliance oversight for manufacturing of biologic and investigational cell-based products..
• Disposition of batches manufactured by Cullinan Therapeutics contract manufacturer(s).
• Provide guidance, support, training, and input on the interpretation and implementation of regulations, guidelines, company procedures, and standards to direct reports and cross-functional internal and external teams.
• Lead, manage, and execute ongoing maintenance and continuous improvements of GMP QA quality systems, including but not limited to, compliance and follow through to completion of audits, documents, deviations, CAPA, change control, complaints, management review, validation, and data integrity.
• Maintain and improve GMP QA quality standards across all areas through quality team leadership and cross-functional collaboration.
• Prepare and present quality related updates, metrics, and trends at internal project, quality management review, and partner meetings.
• Develop, review and/or approve GMP documentation, including but not limited to Specifications, Standard Operating Procedures, Validation Protocols and Reports, Deviations, CAPAs and Change Controls.
• Maintain a prepared state of inspection readiness through training, leadership and collaboration to support CMOs during Agency PAIs.
• Lead the Quality representation for Tech Transfer of investigational products, including active input and decision making related to transfer strategy, protocol development, transfer execution, and final approval.
• Determine and ensure proper qualification, quality oversight and management of CMOs

Candidate Requirements:

• Excellent written and oral communication skills
• Excellent collaboration, negotiation, and team leadership skills
• Team goal setting and planning to achieve results through effective staff management through a positive, engaging, and inspiring management style.
• Effective application of analytical and investigational techniques to identify root cause and problem solve
• Advanced knowledge of aseptic cell processing, testing, and release requirements
• Support company growth through effective staff development
• Internal/External Quality Operations management balancing business needs and compliance standards
• Ever focused on development of business process optimizations
• Ability to prioritize and manage multiple projects within aggressive production schedules
• B.S. / M.S. in microbiology, biological, life sciences, pharmaceutical sciences, or related discipline with at least 10 years QA management experience and at least 15 years related experience.
• Advanced knowledge and experience in aseptic cell processing quality best practices and regulatory requirements, including 21 CFR 210/211, 600s, and 1271.
• Prior experience interfacing with and managing inspections performed by FDA and other regulatory bodies.
• Expert level knowledge of GMP regulations and FDA CBER requirements, Guidance documents, and industry best practices.
• Strong working knowledge of Industry Compendia, regulations, and standards including USP / Ph. Eur, GMP, FDA CBER/EMA, and ICH.
• Knowledge of current best practices and industry standards for tissue sourcing, biologics manufacturing; experience with advanced biologic therapies and aseptic techniques.

Cullinan Therapeutics is proud to be an Equal Opportunity Employer. We are committed to creating an inclusive and diverse environment for all employees and applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law.