- Job Type: Full-Time
- Function: Life Sciences QA/QC
- Industry: Cardiometabolic
- Post Date: 12/03/2023
- Website: www.89bio.com
- Company Address: , San Francisco, CA
About 89BioProtein therapies for NASH, severe hypertriglyceridemia, and other cardiometabolic diseases
89bio is a clinical-stage biopharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of liver and cardio-metabolic diseases. The company's lead product candidate, pegozafermin (BIO89-100), is a specifically engineered glycoPEGylated analog of FGF21. Pegozafermin is being developed for the treatment of nonalcoholic steatohepatitis (NASH) and severe hypertriglyceridemia (SHTG).
Reporting to the Vice President of Quality, the Senior Director of Clinical Quality Assurance is responsible for partnering with Clinical Operations to ensure that quality and compliance are integrated into long term strategies and day to day operations. This role is instrumental in establishing, improving, and maintaining quality systems at 89bio and driving functional and cross-functional projects that embed continuous improvement principles across the company. These responsibilities involve working closely with Clinical Operations, Clinical Development, CMC, Medical Affairs, Regulatory Affairs, CROs, CDMOs, Clinical Trial Sites, and laboratories. This role may have future leadership responsibilities building out a team and require travel.
- Establish and maintain the 89bio GCP QA programs, policies, and procedures and ensure cGCP compliance of clinical trials.
- Act as the primary business partner with internal organizations including Clinical Operations and Clinical Development.
- Act as the primary contact for vendors, contract facilities and contract service providers related to quality aspects of clinical trials.
- Oversee and manage the auditing and qualification process for clinical trial vendors, suppliers and contract organizations and facilities.
- Ensure compliance with applicable health authority regulations and guidelines for document management, TMF, and software used in GCP processes.
- Responsible for writing and maintaining GCP SOPs and providing associated training.
- Understanding and interpreting global regulatory agency policies and guidance and ensuring that 89bio adapts internal policies and procedures accordingly.
- Accountable for the QA review of clinical trial documentation and documents submitted to regulatory agencies.
- Responsible for inspection readiness related to GCP and is the primary liaison with Health Authorities and Partners during internal audits and Health Authority inspections.
- Conducts audits at Clinical Trial Sites, and Contract Research Organizations to ensure the compliant conduct of 89bio Sponsored clinical trials.
- Monitors and manages current and projected quality issues with escalation to 89bio management for any potential issues of significance.
- Bachelor's degree in a scientific discipline (e.g., biology, chemistry, pharmacy).
- 12 years of relevant biotechnology experience including 3+ years in an applicable Sr. Quality leadership role.
- 8 years GCP Quality Assurance experience.
- Solid track record of compliance and successful audits including developing compliant SOPs and practices.
- Experience in developing and maintaining QA systems.
- Prior experience/in-depth knowledge of clinical quality assurance.
- Experience working with CROs.
- Deep knowledge and understanding of drug development process, global regulations, and interfacing related to GXP, and GCP authorities.
- Successful collaboration and open and authentic communication in a diverse workplace; record of strong partnerships with clinical development/operations.
- Strong written and oral communication skills, strong skills in translating complex concepts across all levels of the organization.
- Success working independently in a fast-moving start up environment.
- Reputation for incorporating strong analytical thinking in developing technical and/or business solutions to complex problems.
- Proven track record of driving the successful completion of major programs and projects.
- Comprehensive understanding and wide application of technical principles, theories, concepts, and techniques.
89bio considers a range of factors when determining compensation. These considerations mean actual compensation will vary. The range for this position is $240,000 - $255,000 and will be commensurate with experience.
- Competitive health insurance coverage
- $150/ monthly non-taxable remote work stipend
- Generous PTO allowance
- 401k match
- Employee Stock Purchase Plan (ESPP)
- Commuter Benefits
- Women's forum / mentoring
- Office based in the heart of San Francisco, near plenty of shops and restaurants
- Fun opportunities to engage with co-workers in-person and remotely
All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, sexual orientation, gender identity, national origin, protected veteran status, or based on disability. Proof of Covid vaccination is a condition of employment.
Notice to Recruiters: To protect the interest of all parties, 89bio does not accept unsolicited resumes and we ask that employees, hiring managers and executives not be contacted directly. All recruitment is managed through the 89bio Talent Acquisition Team.