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This position will be a direct-hire (permanent) position with our Biotech client. This will be Hybrid, 2-3 days per week onsite at their Corporate Headquarters in South San Francisco, CA (this is required/firm).
To be considered, candidates must have expertise in CLINICAL GCP Quality Assurance. This is not a GMP role. They must have a good job history within the sponsor side of the pharma/biotech industry.
Position Summary
We're seeking a Quality Assurance (QA) Director/Senior Director to lead the company’s clinical Quality Assurance (cQA) program. The incumbent will assist in the development of quality systems to ensure clinical trials are conducted in accordance with appropriate regulations, guidelines, procedures, and protocols.
The incumbent is also responsible for developing specific internal procedures, training of staff, and hosting regulatory inspections. The position involves managing clinical quality operations and liaison of clinical quality related issues with the company's functional areas. The candidate will perform audits of service providers, study sites, and internal processes.
The successful candidate must have the ability to execute QA tasks independently; effectively represent QA in a GCP focused team setting and manage quality related activities related to clinical vendors, investigator sites and regulatory agencies. In addition, the candidate must actively manage an appropriate level of inspection readiness of the company's clinical stakeholders and act as a catalyst for continuous process improvement.
Responsibilities
Key Qualifications
Full Time
Retail
$154k-188k (estimate)
06/24/2024
07/12/2024
planet-pharma.com
TRIKKANDIYUR, KERALA
100 - 200
<$5M
Retail