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Senior Director/ Director, Clinical Quality Assurance

Employer
Fate Therapeutics
Location
San Diego, CA
Start date
Mar 22, 2023

View more

Discipline
Clinical, Clinical Research, Quality
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
Biotech Beach, Best Places to Work

Job Details

Fate Therapeutics is seeking a highly motivated Senior Director/ Director, Clinical Quality Assurance (CQA). This role is responsible for partnering with Clinical Operations to set the strategy which ingrains Quality and Compliance across all the Good Clinical Practices (GCP) and Good Pharmacovigilance Practices (GPvP) systems and activities. This role will engage a team of dedicated and cross-functional staff to identify and drive continuous improvement and is an active member of the Quality Team. The Senior Director/ Director, CQA will be instrumental in integrating quality throughout all steps of the GCP and GPvP process, monitoring and auditing using risk assessments and tracking and trending the key metrics to drive improved compliance and quality of the GCP activities. The successful candidate will oversee the execution of compliance programs for Fate clinical studies and is a strong advisor/partner to Fate’s Clinical Organizations to ensure compliance with regulations, guidelines, and best practices. This position will require strong depth of understanding of the FDA and international regulations, and guidance documents, and how they can be applied in a risk-based and phase-appropriate manner. The ideal candidate will foster a quality and continuous improvement culture within Fate to ensure all GCP and GPvP activities and deliverables are compliant and appropriate for the clinical phases and ongoing programs.  This is a full-time position reporting to the Executive Director, Quality Assurance, and is located at our corporate headquarters and research facilities in San Diego, California. 
Responsibilities
  • Refine and maintain clinical quality assurance systems, processes, and procedures in accordance with regulatory requirements and ICH guideline
  • Lead and manage Fate’s Clinical Quality Assurance team
  • Ensure GCP compliance of ongoing clinical trials
  • Closely engages with Clinical Development Operations and Clinical Translational organizations on GCP and GPvP needs, and acts as an advisor to help ensure GCP and GVP compliance
  • Support vendor evaluation process and qualification program as it relates to clinical operations for compliance with regulations and company policies
  • Provide interpretation and guidance for internal and external customers on GCP related regulations / guidelines (FDA, ICH, EU, etc.) and company procedures and policies
  • Identify compliance risks and implement risk mitigation, as applicable
  • Monitor, track, and trend GCP non-conformances, deviations, and CAPAs and communicate to management
  • Work closely with the clinical operations teams to provide expert clinical compliance information, manage, and identify issues, and support continuous improvement
  • Ensure clinical documentation in support of TMF is reviewed and archived appropriately
  • Periodically assesses the adequacy of CQA Standard Operating Procedures, with the ability and experience to improve and develop key processes when tasked. Proactively identify gaps or deficiencies in processes and facilitate the remediation.
  • Lead or participate in Systems Audits including development of audit plans and tools, managing audit conduct, and reporting the results
  • Reviews and provides input to pharmacovigilance documents (Safety Management Plans, Pharmacovigilance System Master File, Aggregate reports, etc.)
  • Establish inspection readiness of clinical programs
  • Supports any regulatory inspections, should they occur, and assist in audit readiness preparations
  • Develop and facilitate GCP/GXP training for functional areas and personal involved in the execution of clinical trials.
  • Supports other GxP functions as required

Qualifications
  • BSc, MS, or PhD and 10+ years of relevant experience in positions of increasing responsibility in clinical organization and 5+ years in a Quality Assurance role
  • Good Pharmacovigilance Practice experience, with the ability to support the growth/development of a pharmacovigilance program
  • Significant experience leading external investigator site audits, vendor audits, clinical computerized systems audits, as well as internal process audits
  • Strong understanding and knowledge of application regulations and guidance documents associated with GCP and GPvP, as well as the ICH E6 guidelines; significant experience turning these regulations into real-world applications
  • Direct experience in the preparation and facilitation of regulatory inspections
  • Experience with conducting investigation, root cause analysis, and CAPAs, specifically in the context of GCP regulatory inspection and audit responses is required
  • Proven leadership experience and people management skills
  • Self-starter and leader who can anticipate issues and bottlenecks and resolve issues effectively with minimal oversight.
  • Ability to communicate effectively with people in diverse and different settings
  • Strong verbal and written communication skills and ability to work with others and influence in a positive and collaborative manner
  • Ability to work in a fast-paced and dynamic environment that will require management of several competing priorities while driving projects forward and meeting program/project deliverables
  • Good organizational and project management skills, and ability to perform varied tasks in a functionally independent and consistent manner
  • Strong technical writing skills
  • Able to independently develop and provide compliance related training programs, as tasked

Working Conditions and Physical Requirements
  • Travel may be required (up to 25%)
  • Subject to extended periods of sitting and standing, vision to monitor, and moderate noise levels. Work is typically performed in an office environment, however there is consideration for a potentially mixed virtual/office situation. Onsite work at corporate headquarters in San Diego, CA  

Compensation
  • The salary offer will be based on a variety of factors, including level, experience, qualifications, internal equity, and location
  • Fate offers a competitive employment package that includes an annual bonus, equity, and a generous benefits package
  • The anticipated salary range for this role is $200,000 - $250,000



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.

Equal Employment Opportunity
Fate Therapeutics, Inc. is an equal opportunity employer. We value diversity and are committed to creating an inclusive environment for all employees.

Privacy Notice
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About Fate Therapeutics, Inc.
Fate Therapeutics is a clinical-stage biopharmaceutical company dedicated to bringing a first-in-class pipeline of induced pluripotent stem cell (iPSC)-derived cellular immunotherapies to patients with cancer and autoimmune disorders. Using its proprietary iPSC product platform, the Company has established a leadership position in creating multiplexed-engineered iPSC lines and in the manufacture and clinical development of off-the-shelf, iPSC-derived cell products. The Company’s effector cell pipeline includes multiplexed-engineered, iPSC-derived natural killer (NK) cell and T-cell product candidates, which incorporate novel synthetic controls of cell function, such as chimeric antigen receptors (CARs) to target tumor-associated antigens and are intended to deliver multiple mechanisms of therapeutic importance to patients including in combination with well-established cancer therapies. Fate Therapeutics is headquartered in San Diego, CA. For more information, please visit www.fatetherapeutics.com.

Company

Fate Therapeutics is a clinical-stage biopharmaceutical company dedicated to bringing a first-in-class pipeline of induced pluripotent stem cell (iPSC)-derived cellular immunotherapies to patients with cancer and autoimmune disorders. Using its proprietary iPSC product platform, the Company has established a leadership position in creating multiplexed-engineered iPSC lines and in the manufacture and clinical development of off-the-shelf, iPSC-derived cell products. The Company’s effector cell pipeline includes multiplexed-engineered, iPSC-derived natural killer (NK) cell and T-cell product candidates, which incorporate novel synthetic controls of cell function, such as chimeric antigen receptors (CARs) to target tumor-associated antigens and are intended to deliver multiple mechanisms of therapeutic importance to patients including in combination with well-established cancer therapies. Fate Therapeutics is headquartered in San Diego, CA. For more information, please visit www.fatetherapeutics.com.

Company info
Website
Phone
858.875.1800
Location
12278 Scripps Summit Drive
San Diego
California
92131
United States

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