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Position Summary
Reporting to the Chief Technology Officer, the Senior Manager/Associate Director of Clinical GCP Quality will be responsible for evaluating and mitigating risk of global clinical development programs, from initiation through completion of clinical trials, with inspection readiness in mind throughout. The ideal candidate will advise on company clinical quality strategy, ensure compliance to regulations, oversee quality management systems and interact directly with cross functional clinical, regulatory and quality teams. The ideal candidate will have at least 10 years of experience in clinical quality, process improvement, regulatory inspection management and at least two years of clinical auditing experience as lead auditor. The candidate will have an excellent working knowledge of Good Clinical Practices (ICH E6), quality requirements and other international regulations (e.g. US, EU, Taiwan, India, Japan) are desirable.
Key Duties and Responsibilities
Desired Education, Skills and Experience
REQUIREMENTS:
Physical Demands
None, other than those necessary to perform the essential job functions
Manual Dexterity
None, other than those necessary to perform the essential job functions
Audible/Visual Demands
Ability to interpret the letters and numbers when viewed on a personal computer screen, PDA, reports and other documents.
Environment
None, other than those necessary to perform the essential job functions.
Travel
Up to 30%
The expected salary range for this position based in California is $175,000 to $220,000 annually. Actual pay will be determined based on experience, qualification, geographic location, and other job-related factors. Company is posting role confidentially.
Full Time
$146k-175k (estimate)
07/02/2024
07/15/2024