Enigma Search Solutions
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. The Quality Assurance Manager will provide support and problem-solving expertise to ensure clinical trial and research activities are conducted in full compliance with global guidelines and regulations.
The successful candidate will: 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.
Provide GCP guidance to ensure compliance with applicable regulations. 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.
Manage, develop, and improve Standard Operating Procedures to ensure quality. Manage, develop, and deliver GCP training. 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. Perform a wide variety of activities to ensure compliance with requirements.
Position requirements: 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 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. Self-motivated and adaptable to a dynamic and diverse environment Certification by industry-recognized professional organization (e.g. Certified Quality Auditor, Certified Quality Manager) is desirable Able to travel 10–15% of time Must be willing to work onsite three days a week The estimated base salary range for this role is $157,000 - $165,000. Actual pay will be based on a number of factors including experience and qualifications. This position is also eligible for two annual cash bonuses.
June 30, 2023
South San Francisco
Nov. 12th, 2022
The BioPacific Conference is the annual flagship event of the CABS. Our mission is to bring scientists, executives, and bio-pharmaceutical professionals from the Pacific Rim countries together to discuss the latest advances in the world of life sciences, the unprecedented challenges and promises facing the industry, and the breath-taking developments and opportunities in Asia/Pacific countries