Vice President, Quality (GXP) - cutting edge CAR T focus

Poseida is seeking an outstanding candidate to further build and lead all GxP Quality functions across the company.  This will include internal and external manufacturing and testing, R&D and Clinical, Quality Control, and Quality systems. The VP, Quality will build and lead a talented team of professionals ensuring GxP compliance with all country regulations and guidelines and the company’s policies and procedures. The VP, Quality will be a member of the Senior Leadership Team.

Responsibilities
These may include but are not limited to:

• Drive and cultivate a culture of quality throughout the company to help ensure compliance with all applicable regulations, guidelines, and corporate standards, policies, and procedures
• Continue to build and expand the company’s Quality System to ensure that it is optimally designed and implemented
• Lead the development and reporting of Quality metrics and periodic reporting describing compliance trends and any areas of risk with associated mitigation plans
• Lead and facilitate Quality related continuous improvement initiatives and activities
• Ensure that the company, its contractors and vendors are prepared for FDA and Health Authority inspections
• Coordinate and host all FDA and Health Authority inspections
• Provide expert GxP leadership and guidance across all functional areas in the company
• Continue to build and scale the Global Quality organization
• Drive corporate and departmental objectives and goals to completion by leveraging strong collaborations across internal and external functions and all levels of management

Requirements, Knowledge, Skills and Abilities

• Minimum of Bachelor’s degree in a scientific discipline with at least 15 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
• Experience in leading high performing Quality teams
• Experience in hosting FDA and Health Authority inspections
• Experience working with US and EU CMOs and clinical sites
• Excellent people leader with strong coaching and mentoring skills
• 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 (T_SCM). T_scm 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.