Manager/Sr. Manager, Clinical Quality

4 days ago

San Francisco, California, United States Meet Life Sciences Full time

I'm working exclusively with a clinical-stage biotech who focuses on reimagining cell therapy through the development of innovative immunotherapies. They are seeking a Manager / Sr. Manager Clinical Quality to support all GCP quality oversight for phase I, II and III clinical studies.

What you'll do:

  • Partner closely with Clinical and Medical Affairs to ensure the quality system is compliant, inspection-ready, and supports successful trial execution.
  • Act as a Clinical Quality Lead by supporting study team compliance with national and international regulatory standards and guidance for cell therapy products
  • Coordinate, plan and conduct internal system audits and external investigative site/vendor audits in accordance with GCP guidelines
  • Develop and conduct training for staff (GCP, Inspection Readiness training, etc.).
  • May be asked to supervise others in the clinical quality function.
  • Support preparation for and execution of regulatory inspections.

Skills and Experience needed:

  • Bachelor's degree and 8+ years' experience working within GCP a pharmaceutical or biologics environment. Experience with GLP and GVP is a plus.
  • Experience implementing and integrating clinical quality systems in CBER regulated biotechnology companies. Cell and gene therapy and especially CAR-T therapy a plus
  • Ability to travel up to 20% of time domestically and internationally.

Contact Details
:

If interested, apply now or contact Kelly Komon
:

Benefits:

Benefits provided by Meet Recruitment

Equal Opportunity Employer:

Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to age, ancestry, color, disability (mental and physical), exercising the right to family care and medical leave, gender, gender expression, gender identity, genetic information, marital status, medical condition, military or veteran status, national origin, political affiliation, race, religious creed, sex (including pregnancy, childbirth, breastfeeding and related medical conditions), or sexual orientation, or any other status protected by federal, state or local laws in the locations where in operation.

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