Executive Director / Senior Director, Quality Assurance Operations

Location
San Diego, CA, United States
Posted
Apr 03, 2021
Ref
472JB
Hotbed
Biotech Beach
Required Education
Bachelors Degree
Position Type
Full time
Fate Therapeutics is seeking an experienced and motivated Quality Assurance (QA) leader with extensive experience in leading and developing QA Operations. This role will provide managerial, technical, operational, and strategic leadership in support of clinical and
commercial manufacturing for internal and external manufacturing operations. This position will be responsible for QA Operations activities to ensure clinical and/or commercial products are manufactured in accordance with cGMP, corporate and regulatory requirements and will implement and oversee quality systems aligned with Fate's business strategy, industry standards, in-house specifications/procedures, GMP and global regulatory requirements. This position will also oversee the on-going validation compliance of equipment, systems and processes through start-up and in on-going manufacturing. This position will require strong cross-functional collaboration with Regulatory Affairs, Quality Control (QC), Analytical Development, Pharmaceutical Development, Manufacturing Operations, Facilities, Program Management, and Clinical Development teams. This is a full-time position reporting to the VP, Regulatory Affairs and Interim Head of Quality and is located at our corporate headquarters in San Diego, California.

Responsibilities
• Lead and manage high-performing QA Operations team; continue to build and scale the QA Operations organization.
• Engage with all levels of the organization, including program and functional areas, as well as with external vendors (CROs and CMOs), and qualified persons, to assure projects are planned and executed according to company processes and are aligned with industry best practices.
• Provide technical expertise for all QA and compliance topics/issues relating to manufacturing, validation and product supply.
• Provide quality oversight of validation (and appropriate re-validation) of all equipment, processes and control.
• Manage the review/approval of all manufacturing, testing documentation and support
records for cell banks and clinical drug substance and drug product support to certify compliance with specifications and procedures; ensure timely resolution of documentation and quality system issues.
• Serve as an authorized contact for and host/manage GMP audits and inspections by all Health Authorities.
• Perform timely review of documentation/investigations/reports highlighting and assisting in the resolution of issues commensurate with the level of risk.
• Ensure relevant QA and validation documents and procedures are approved to schedule to support technology (external and internal) transfers and new product introductions.
• Provide support for deviation investigations, including root cause analysis, and corrective and preventative action ("CAPA") proposals and initiatives. Administer the change control, deviation and CAPA systems on site.
• Deliver QA review and approval of Standard Operating Procedures ("SOPs"), master batch records, policies, operational standards, validation protocols and reports, as required.
• Develop and report quality metrics and period reporting describing compliance trends
and any areas of risk with associated mitigation plans.
• Maintain current knowledge base of regulations, corporate policies, and industry best practices, trends, and standards to ensure that the QA function and the Quality Management System remain in compliance with applicable company requirements and global regulations.
• Establish continuous learning and improvement programs for the QA team, thereby
ensuring all team members are engaged and passionate about their work.
• Promote a company-wide culture of safety, quality, and responsible mindset. This includes having appropriate metrics and community ownership of these key cultural traits.
• Other duties as may be required.

Qualifications
• B.S. degree in life sciences with a minimum of 10 years of relevant experience in QA
Operations with cGMP experience in the pharmaceutical/biotechnology industry; advanced degree is preferred.
• In-depth technical and regulatory understanding of biologics, gene, or cell therapy, as well as applicable international regulations and standards in all phases of clinical development.
• Extensive experience supporting clinical and commercial products maximizing
performance, scaling quality operations and streamlining quality systems, while maintaining the highest levels of compliance to global regulations.
• Excellent understanding of QA principles, industry practices and standards with demonstrated ability to apply these to GMP operations.
• Thorough knowledge of global regulations and thorough quality system experience (deviations, CAPAs, change control, validation concepts for pharmaceutical drug
substance and drug product manufacturing).
• Proven leadership of high-functioning QA teams and people management skills.
• Early to late clinical stage and commercial cGMP and CMC experience.
• Established experience working with and management of third party contractors and
vendors.
• Experience with regulatory submissions, ideally for products which were ultimately approved for commercial distribution, and regulatory inspections.
• Strong collaboration, team-building, and organizational skills are required; proven ability to effectively develop, communicate, and gain support for execution of plans and strategies with a wide range of stakeholders.
• Excellent judgment and creative problem-solving skills, including negotiation and
conflict resolution skills, and excellent interpersonal, organizational, and written and oral communication skills.
• Ability to work in a fast paced and dynamic environment that will require management of several competing priorities while driving all projects forward and meeting program/project deliverables
Working Conditions and physical requirements
• Will require 10%-20% travel
• Occasional weekend and/or evening hours required
• Full-time onsite work at corporate headquarters in San Diego, CA
The preceding job description indicates the general nature and level of work performed by employees within this classification. Additional and incidental duties related to the primary duties may be required from time to time. For consideration send cover letter and resume to: careers@fatetherapeutics.com and reference job code 472JB.

About Fate Therapeutics, Inc.

Fate Therapeutics is a clinical-stage biopharmaceutical company dedicated to the development of first-in-class cellular immunotherapies for patients with cancer. The Company has established a leadership position in the clinical development and manufacture of universal, off-the-shelf cell products using its proprietary induced pluripotent stem cell (iPSC) product platform. The Company's immuno-oncology pipeline includes off-the-shelf, iPSC-derived natural killer (NK) cell and T-cell product candidates, which are designed to synergize with well-established cancer therapies, including immune checkpoint inhibitors and monoclonal antibodies, and to target tumor-associated antigens using chimeric antigen receptors (CARs). The Company's pipeline also includes ProTmune™, a pharmacologically modulated, donor cell graft that is currently being evaluated in a Phase 2 clinical trial for the prevention of graft-versus-host disease in patients with hematologic malignancies undergoing allogeneic stem cell transplant. Fate Therapeutics is headquartered in San Diego, CA. For more information, please visit www.fatetherapeutics.com.