Full Job Description
Director Quality Assurance (QA), GxP - Obsidian Therapeutics
About the Company:
Obsidian Therapeutics is a biotechnology company that is pioneering the development of controllable cell and gene therapies to deliver transformative outcomes for patients with intractable diseases. Obsidian’s lead programs are in adoptive immune cell therapy. Obsidian’s programs apply our CytoDriveTM technology in Cell Therapy products to control expression of proteins for enhanced therapeutic efficacy and safety.
We are looking for a highly talented, collaborative, and experienced Director of Quality Assurance (QA) to partner with Head of Regulatory Affairs (RA) and Quality Assurance in building a QA function.
This role is a unique opportunity to be a have a key role in a well-funded startup with blue chip investors, field-leading founders and advisors, and a highly experienced biotech team. You will help us to continue to build a dynamic, passionate, collaborative, transparent and successful organization focused on delivering transformative therapies in oncology and other areas of greatest clinical need. Located in an energetic environment in the heart of Cambridge, Obsidian is an equal opportunity employer offering a competitive salary and benefits package.
This newly created position reports to the Vice President of Regulatory Affairs and Quality Assurance and will partner with the V.P. to build a QA function within Obsidian. In this role, the Director of QA will lead planning and execution of establishing quality management systems and practices and perform/manage QA activities related to GxP with an initial emphasis on GMP. The position requires excellent communication skills, and a desire and willingness to work in a fast-paced entrepreneurial environment.
- Develop and oversee a quality management system in compliance with regulations for GxP activities; lead implementation and ensure effectiveness across departments
- Design, implement, and maintain QA and GxP compliance programs and infrastructure, including SOP development/maintenance, document control/change control processes, internal/external audits, deviation review and tracking, investigations, and corrective and preventative action
- Manage training programs for internal staff and Obsidian representatives overseeing or performing GxP activities and serve as an in-house advisor on GxP compliance
- Initiate continuous improvement activities, create/revise procedures/practices and specifications, and provide training on quality systems and procedures.
- Perform vendor qualification and oversight, including CDMOs, GLP study testing facilities, Contract Reach Organizations supporting clinical activities; and maintain quality agreements
- Enable sustainable compliance with international quality standards and applicable programs and initiatives; proactively identify compliance issues/risks, within the organization and with its external partners, and regularly report to management on compliance activities and findings
- GMP specific responsibilities:
- Effectively collaborate with internal technical manufacturing lead and manage all third parties contracted to perform GMP manufacturing activities to ensure full compliance.
- Perform batch release activities and review reprocessing and rework procedures.
- Oversee GMP testing to assure conformance with protocols, policies and GMP regulations.
- Plan and conduct audits and inspection readiness of manufacturing and release sites. Manage product complaints and investigations for clinical supplies.
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
- Bachelor’s degree in a life science required; Master’s Degree or PhD in scientific discipline a plus
- 10+ years of relevant work experience in biotechnology/pharmaceutical Quality Assurance
- Solid and demonstrable knowledge of international GxP regulations and guidelines, industry practices, and experience implementing Quality Systems in a regulated environment
- Ideal candidate will have broad experience in product development, regulatory compliance, GxP auditing
- Strong organization and time management skills
- Excellent attention to detail with an ability to perform critical review of various types of documents
- Outstanding written and verbal communication skills
- Ability to independently solve problems, lead projects, and influence teams
- Experience identifying and evaluating risks, and executing efficient and effective mitigations
- Demonstrated ability to work as a team player with multi-disciplinary project teams
- Proficiency with commonly used word processing, database systems, document management and quality systems
Job Type: Full-time
- management: 1 year (Preferred)
- Registered Nurse (RN) (Preferred)