Jasper Therapeutics is a biotechnology company focused on developing new therapies to treat both chronic and life-threatening diseases.
Our mission is to make safer and potentially curative therapy possible for more patients in need. We are bringing together a team of high performing biotech professionals, leading academic institutions and a strong syndicate of healthcare-focused investors to achieve our vision.
Reporting to the Senior Vice President of Regulatory & Quality, and based in our Redwood Shores Office, the Vice President of Quality will lead, direct, and develop the jasper Quality organization.
This position will provide strategic guidance to senior leadership in the development, adoption, communication, and training of all employees and external contractors/vendors regarding corporate GxP quality practices/standards, and setting the expectation of compliance by following strict quality standards throughout clinical product development and production.
The role will serve as a subject matter expert and resource to corporate functions for interpretation of FDA and regulatory agency regulations and guidelines, as well as corporate standards and policies related to GxPs.
Key Responsibilities
- Guides and supports senior leadership in identifying a quality strategy and developing supporting policies.
- Provides systems support and quality operations to ensure compliant drug development and manufacturing, regulatory communications, and clinical and ultimately commercial distribution. Establishes a foundation of quality in all GxP operations, in support of manufacturing, clinical development, pharmacovigilance and regulatory affairs.
- Ensures consistent application of quality standards through the development of Standard Operating Procedures (SOPs), with the preparation and maintenance of the SOPs overseen by the Quality organization.
- Plans and conducts/coordinates GxP (GCP, GLP, GMP) audits, to ensure inspection readiness both internally and at vendors, in accordance with established timelines and within budget, as necessary.
- Plans, schedules, prepares for, conducts, reports, and closes out all audits undertaken. This may include, but is not limited to, audits of clinical study documents (protocols, amendments, informed consent, clinical study reports, advertisements), Project set-up, Project In-Life, Investigator Sites, databases, study reports and sub-contractors.
- Assures that Quality is present in all manufacturing validation and all regulatory documentation.
- Serves as a liaison with the FDA and regulatory agencies.
- Oversees and manages all quality and compliance issues, ensuring appropriate CAPA (corrective and preventive action) plans are defined and implemented.
- Advises senior leadership and functional management regarding quality compliance issues, assessing risk and determining actions necessary to resolve issues.
We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.
