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Director Clinical Quality Assurance
146090
Posted:
09th
February 2024
- 200000 USD - 200000 USD
- South San Francisco , United States
- Permanent
We are partnering with an exciting and growing Pre-IPO biotech to help find them a Director of Clinical Quality Assurance to add to their team. The position involves close collaboration with various departments, including Clinical Operations, Clinical Development, CMC, Medical Affairs, Regulatory Affairs, CROs, CDMOs, Clinical Trial Sites, and laboratories.
Responsibilities:
- Develop and sustain GCP QA programs, policies, and procedures, ensuring clinical trials comply with cGCP standards.
- Act as the main liaison with internal departments such as Clinical Operations and Clinical Development to foster collaborative partnerships.
- Serve as the primary contact for vendors, contract facilities, and service providers, overseeing quality aspects of clinical trials.
- Manage and supervise the auditing and qualification processes for clinical trial vendors, suppliers, and contracted organizations and facilities.
- Ensure compliance with health authority regulations and guidelines related to document management, Trial Master File (TMF), and software used in GCP processes.
- Draft and maintain Standard Operating Procedures (SOPs) for GCP and provide necessary training.
- Interpret and align global regulatory policies and guidance with internal policies and procedures at 89bio.
- Review clinical trial documentation and regulatory submissions from a Quality Assurance perspective.
- Oversee GCP inspection readiness and serve as the primary liaison with Health Authorities and Partners during audits and inspections.
- Conduct audits at Clinical Trial Sites and Contract Research Organizations to ensure compliance in clinical trials.
- Monitor and address current and potential quality issues, escalating significant concerns to management as needed.
Qualifications:
- Bachelor's degree in a scientific discipline (e.g., biology, chemistry, pharmacy).
- At least 12 years of experience in biotechnology, with 3+ years in a senior quality leadership role.
- Minimum of 8 years of GCP Quality Assurance experience.
- Proven track record in compliance and successful audits, developing compliant SOPs and practices.
- Experience in developing and maintaining QA systems and working with CROs.
- Knowledge of the drug development process, global regulations, and GXP and GCP-related interfacing.
- Demonstrated ability to collaborate and communicate effectively in a diverse workplace, with strong partnerships in clinical development/operations.
- Excellent written and oral communication skills, with the ability to translate complex concepts across all organizational levels.
- Ability to work independently in a fast-paced startup environment.
Leila Johnston
Division Director