Biotech in South San Francisco
Manager, Quality Assurance (Good Clinical Practice)
Company is seeking a Quality Assurance Manager, GCP to join a small team responsible for advancing exciting drug candidates in clinical trials to treat age-related diseases with high unmet medical need. Provide support to ensure clinical trial and research activities are conducted in full compliance with global guidelines and regulations.
- Identify, manage, and perform internal and external GCP audits.
- Write, review and approve GCP documents such as agreements, plans, and reports.
- Perform and/or oversee internal and external GCP quality investigations to ensure that issues are thoroughly evaluated and appropriate actions are taken.
- Work independently to innovate processes and make continuous improvements to the quality management system.
- Develop, maintain and present metrics that measure quality performance.
- Support internal and external health authority inspections. Interface with health authorities as required.
- Deliver, train and create GCP training to parties
- Implement and maintain the validated state of electronic systems associated with the QA function. Provide QA guidance/oversight for other regulated electronic systems implemented at company
- BA/BS degree required with 7 years minimum experience in the pharmaceutical/biotech industry including at least 5 years of experience in a clinical quality assurance role
- Must be willing to work onsite three days a week
- Strong knowledge of QA principles, global guidelines and regulations, especially FDA, EU, and ICH GCP regulations & guidelines
- Understanding of computer system validation and change management
- Experience conducting and coordinating audits of clinical sites, vendors and internal systems
- Working knowledge of health authority inspections and inspection readiness activities
- Strong leadership skills, critical thinking, and judgment
- Excellent verbal, written and interpersonal communication to build and maintain positive working relationships with cross-functional stakeholders. Ability to negotiate.
- Certification by industry-recognized professional organization (e.g. Certified Quality Auditor, Certified Quality Manager) is desirable
- Able to travel 10–15% of time
May 27, 2023
South San Francisco
Nov. 12th, 2022
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