Poseida is seeking an outstanding candidate to further build and lead our Quality Management System (QMS) . This position with focus on establishing and maintaining QMS procedures and controls to meet regulatory requirements. Assessing the effectiveness of the QMS through regular analysis of metrics, internal audits, corrective and preventive actions, customer feedback, and other activities as appropriate. Monitoring metrics for the measurement of Quality Indicators to ensure the effectiveness of the QMS and Management Review.
These may include but are not limited to:
- Lead and direct GXP processes for CAPA, complaints, change management, training, audits, deviation management and document & archival management
- Lead the process for management review associated with CAPA, deviations, document management, training, and change control and ensure appropriate escalation of adverse trends
- Lead the trending and metrics programs for Quality Systems related metrics; assess each functional area for trends and opportunities for improvement
- Ensure Quality and Technical Agreements are strategically aligned with QMS requirements for notifications and delegation of responsibilities
- Develop the QMS team with identification and on-boarding of key positions in oversight of quality management systems and applicable regulations.
- Drive the GMP/GDP change management program and implement efficient processes for the notification, assessment and implementation of changes to support program timelines
- Provide estimates for budget planning as needed to identify audits, travel requirements, training and development of employees, systems, head count and other areas where financial resources are necessary
- Analyze industry trends and anticipate changes in the competitive or regulatory landscape to adjust Quality Systems plans as needed
- Facilitate or support inspections by regulatory authorities and maintain a state of inspection readiness
- Participate in the development of responses to agency observations or deficiencies and ensure CAPAs are completed timely with appropriate effectiveness verification
- Implement and manage the quality management system, the document control system, and the learning management system
- Continue to build and expand the company’s quality system to ensure that it is optimally designed and implemented
- 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
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
- Experience in leading high performing Quality teams
- Experience implementing and managing QMS, Document Control, and LMS systems
- Experience in hosting FDA and Health Authority inspections
- 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 10% 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 email@example.com.