Poseida is seeking an outstanding candidate to further build and lead GCP, GLP, and GPVP capabilities. The Sr. Director of R&D Quality and Compliance will serve as a strategic and tactical quality professional in managing compliance related to Good Clinical Practices (GCP’s),Good Laboratory Practices (GLP’s), Good Pharmacovigilance Practices (GPVP’s) and other related activities. Responsible for ensuring oversight of compliance with GCP, GLP, and GPVP global regulations, industry best practices, and internal policies and procedures, including designing and implementing a risk- based audit program. Partner with the Clinical Development and Clinical Operations organizations to provide strategic GCP, GLP, and GPVP compliance oversight for clinical studies and internal operations..
These may include but are not limited to:
- Attend project meetings, representing Quality and Compliance and provide GCP/GPVP/GLP insight and oversight
- Manage and perform GCP/GPVP/GLP audits: Investigational sites, various vendors supporting conduct of clinical studies, GCP/GPVP/GLP system audits, clinical studies report, etc.
- Evaluate audit observations and trends and develop periodic compliance reports for management
- Monitor and drive quality issues to resolution. (e.g., Closure of Audit Reports, develop and track post auditing corrective actions plans, as applicable)
- Responsible for managing GCP/GPVP/GLP compliance activities / non-conformances associated with drug development programs
- Understand and interpret current pharmaceutical regulations and ICH guideline requirements pertaining to GCP/GPVP/GLP and advise the Clinical development teams on all relevant issues
- Review Clinical Development and Pre-clinical SOPs to ensure compliance with all applicable regulatory authorities
- Work in conjunction with other Quality areas to ensure proper representation throughout the organization, as needed
- Conduct internal system audits to ensure compliance with applicable regulations, SOPs and policies and advice on process improvements in the functional areas
- Ensure annual audit plans are developed and audit activities are completed according to plan
- Lead management of regulatory agency inspections and coordination of responses to any regulatory agency finding
- May lead change projects which have strategic impact on the organization
- Analyze trends in industry/regulatory environment that would necessitate future changes
- Facilitate and support inspection readiness activities
- Develop and provide independent periodic reports to Poseida management on overall compliance status
- Ensure that the company, its contractors and vendors are prepared for FDA and Health Authority inspections
Requirements, Knowledge, Skills and Abilities
- Minimum of Bachelor’s degree in a scientific discipline with at least 12 years of work experience in the Pharmaceutical/Biotechnology industry with at least 5 years in Quality (an equivalent combination of education and experience may be considered)
- Expert knowledge of FDA and ICH GxP regulations and guidelines with focus on GCP, GLP, and GPVP
- Experience in leading high performing Quality teams
- Experience in hosting and managing GCP FDA and Health Authority inspections
- Excellent people leader with strong coaching and mentoring skills
- Experience identifying and evaluating risks and executing efficient and effective mitigations
- Practical knowledge and experience identifying key performance metrics for quality indicators, setting targets to maintain a state of control while identifying areas for improvement.
- Track record of strong personal performance combined with demonstrated ability to build and lead high performing teams in a fast growth environment
- Demonstrated problem-solving and critical thinking skills
- Demonstrated ability to work effectively in a dynamic, complex and fast-paced team environment
- Travel may be required up to 20% of the time
Who We Are and What We Do
Poseida is a San Diego based biotechnology leader in the development of cell and gene therapies. We have built a wholly-owned pipeline of autologous and allogeneic chimeric antigen receptor T cell, or CAR-T, product candidates, initially focused on the treatment of hematological malignancies and solid tumors. Here at Poseida we are constantly innovating and growing as we advance our CAR-T therapies in the clinic and our gene therapies currently under development. The Poseida team is passionate about the impact we are making in developing treatments, or even cures, for patients with cancer or other genetic diseases.
The company’s CAR-T product candidates are manufactured with Poseida’s non-viral piggyBac® DNA Modification System, resulting in a high percentage of stem cell memory T cells (TSCM). Tscm cells are the only T cells that are self-renewing and long-lived, potentially resulting in product candidates that are more efficacious, less toxic and more durable. Poseida is currently developing the following CAR-T product candidates:
- P-BCMA-101 is an autologous CAR-T therapy for the treatment of relapsed/refractory multiple myeloma, currently enrolling patients for a Phase 2 registrational trial with initial dosing expected in the first half of 2019.
- P-PSMA-101 is an autologous CAR-T product candidate targeting PSMA-specific cancer cells in castrate resistant prostate cancer, with filing of an IND anticipated in the second half of 2019.
- P-BCMA-ALLO1 is an allogeneic, or universal donor, CAR-T product candidate, manufactured using Poseida’s proprietary Cas-CLOVER™ site specific gene editing system and is being developed as a treatment for relapsed/refractory multiple myeloma, with an IND filing anticipated by late 2019 or early 2020.
- P-MUC1C-101 is an autologous CAR-T product candidate in late-stage preclinical development for numerous solid tumor indications, including ovarian, breast, lung, colorectal, pancreatic and renal cancers, with filing of an IND anticipated in 2020.
Poseida plans to broadly advance its current CAR-T programs and emerging pipeline programs, including gene therapies for orphan genetic diseases.
To apply send your resume and cover letter to firstname.lastname@example.org.