What are the responsibilities and job description for the Manager, Clinical and Pharmacovigilance (PV) Quality Assurance position at Precigen?
Precigen is a dedicated discovery and clinical stage biopharmaceutical company advancing the next generation of gene and cell therapies using precision technology to target the most urgent and intractable diseases in our core therapeutic areas of immuno-oncology, autoimmune disorders, and infectious diseases.
Precigen has developed a novel manufacturing processes to deliver AdenoVerse™ and UltraCAR-T® immunotherapies to patients. We have multiple products being evaluated in the clinic using our innovative manufacturing approach to cell and gene therapies. Our lead product, PRGN-2012, has potential to be the first FDA-approved therapeutic for treatment of RRP, a rare and devastating chronic disease.
Precigen is seeking a highly motivated and skilled Manager, Clinical and Pharmacovigilance (PV) Quality for our Quality Assurance (QA) GCP and PV function. This role will work on the development, implementation and execution of GCP and PV Quality Systems for Precigen while managing all GCP and PV activities of the QA department. He/she works closely with personnel and leaders in product development functional areas to ensure compliance with applicable regulations, industry standards as well as regulatory requirements and commitments.
DUTIES AND RESPONSIBILITES:
Precigen has developed a novel manufacturing processes to deliver AdenoVerse™ and UltraCAR-T® immunotherapies to patients. We have multiple products being evaluated in the clinic using our innovative manufacturing approach to cell and gene therapies. Our lead product, PRGN-2012, has potential to be the first FDA-approved therapeutic for treatment of RRP, a rare and devastating chronic disease.
Precigen is seeking a highly motivated and skilled Manager, Clinical and Pharmacovigilance (PV) Quality for our Quality Assurance (QA) GCP and PV function. This role will work on the development, implementation and execution of GCP and PV Quality Systems for Precigen while managing all GCP and PV activities of the QA department. He/she works closely with personnel and leaders in product development functional areas to ensure compliance with applicable regulations, industry standards as well as regulatory requirements and commitments.
DUTIES AND RESPONSIBILITES:
- Manage execution of the Precigen GCP and PV Quality System for the full lifecycle of Precigen products (preclinical, clinical and post-marketing).
- Ensure compliance with all regulations, requirements and industry standards.
- Manage all tasks and responsibilities of GCP and PV QA.
- Standard Operating Procedure (SOP) development, management and control.
- Review and approval of GCP and PV governing documents (SOPs, Policies, etc.).
- Assist/lead the investigation and closure of GCP and PV quality issues.
- General “Champion” for GCP and PV Quality within Precigen; active member of Precigen’s QA leadership team.
- Develop and report GCP and PV Quality metrics for performance of the Quality System and GxP compliance.
- Partner closely with Clinical and Pharmacovigilance functions to support compliant execution of clinical trials and pre- and post-marketing pharmacovigilance activities.
- Lead GCP and GVP inspection preparation activities and ensure ongoing global inspection readiness.
- Oversee GCP and GVP audit programs.
- Implement a Quality-by-Design approach to embed quality in GCP/GVP activities.
- May lead/manage GCP and PV inspections by FDA or other regulatory bodies.
- Assist in the authorship and/or review of company policies, procedures, SOPs, and work instruction documents as they relate to GxP.
- Assist with writing, compiling, and reviewing INDs and other regulatory filings.
- Participate, assist and provide input on product and process development projects.
- Bachelor’s degree in Life Sciences or related field.
- Five (5) years of QA experience in the pharma/biopharmaceutical industry, at least 2 years of experience in a Clinical/PV QA function.
- Experience in development and implementation of Quality Systems is preferred.
- Experience with FDA submissions.
- Experience with global GCP and PV regulatory requirements, including post-marketing global PV requirements.
- Strong knowledge of global regulatory and compliance standards.
- Experience with regulatory inspections.
- Experience in Quality aspects of preparation efforts for product development.
- Experience and success in leading a company through pre-approval and post-approval Regulatory inspections is a plus.
- Gene and cell therapy experience is a plus.
- Strong planning, organization, and execution skills.
- Ability to understand and execute on the company’s mission and values.
- Strong analytical and decision-making skills with attention to detail and quality.
- Exhibits impeccable confidentiality on sensitive, supporting tasks.
- Ability to anticipate and solve problems while analyzing complex issues and environments.
- Ability to communicate and work effectively with all levels of employees in various communication mediums.
- Possess a high degree of personal responsibility.
- Ability to adapt and succeed in a milestone-driven, rapidly changing product development and commercialization environment.
- Ability to prioritize and re-prioritize activities as needed to accomplish unanticipated requests or initiate new projects requiring immediate attention.
- Demonstrates the highest ethical standards and trustworthiness.
- Strong verbal and written communication and interpersonal skills.
