Director, Quality Assurance GCP
- 2200 Bridge Pkwy, Redwood City, CA 94065, USA
Jasper Therapeutics is a start-up company out of Stanford University with a lead clinical-stage program that is a first-in-class and potentially breakthrough antibody to safely replace chemo-radiation as a conditioning agent for diseases for which hematopoietic cell transplants (HCT) of allogeneic or gene-modified cells are the only known curative therapy. These diseases include but are not limited to rare genetic blood diseases such as the primary immune deficiency diseases, hemoglobinopathies, and myeloid disorders including myelodysplastic syndrome and acute myeloid leukemia. Additional potential indications include immune tolerance induction for the cure of autoimmune disorders and to facilitate acceptance of solid organ transplants. By creating novel, safe and highly effective conditioning regimens for hematopoietic transplantation, Jasper is leading the field with innovative clinical trials to safely bring cures to patients suffering from a variety of life-threatening diseases.
The Jasper vision is to build a leading biotechnology company to advance the field of hematopoietic cell transplantation by leveraging its basic and translational science to generate a pipeline of innovative therapeutics in the areas of HCT conditioning, immune modulation, cell engineering and gene editing therapies.
- Develop and implement GXP including GMP, GLP and GCP quality systems in accordance to ICH, FDA, EMA and global competent authority regulations and industry guidance
- Provide compliance oversight for internal and contracted external GXP activities
- Prepare and implement audit plans and audit CAPAs for all CROs, CDMOs, GCLP and GMP testing laboratories, GLP animal laboratories, clinical sites, and internal departments.
- Provide quality oversight for GMP CDMOs and manage GMP product batch record review and disposition.
- Lead and ensure inspection readiness activities for all internal and external entities
- Lead and host GCP, GLP, GMP inspections. Follow up to any responses and CAPAs
- Develop, implement, and manage the quality management systems including deviation and CAPA systems
- Develop and implement overall GXP strategy, performance metrics, analytics, and reports
- Bachelor’s degree in biological sciences or related field with minimum of 10 years’ experience in a pharmaceutical setting..
- Proven, extensive knowledge of worldwide GXP regulatory requirements, industry practices, and ability to apply concepts. Experience with GMP, GCP and GLP regulations and current industry standards.
- Experience in designing and implementing quality systems and risk management tools
- Experience leading/hosting US and international health authority inspections/interactions
- Excellent interpersonal, verbal, and written communication skills are critical in our collaborative work environment
- Must demonstrate high organizational, prioritization and management proficiencies
- Ability to deliver in a fast-paced, small company environment and tenacity to seamlessly adjust workload based upon changing priorities
- Experience interacting with and managing CMOs for DS and DP especially biological products
information will be kept confidential according to EEO guidelines.