Head of Site Quality
Confidential
Head of Site Quality
About the Company
A global leader in life sciences and biotechnology.
Industry
Biotechnology
Type
Privately Held
About the Role
The Company is seeking a Senior Manager for Quality Excellence to take on a pivotal site leadership role. The successful candidate will be the Quality Management Representative for the site, overseeing the Quality Assurance, Quality Control, and Quality Laboratory teams. This role is focused on ensuring the Quality Management System is in compliance, robust, and continuously improving. The Senior Manager will also be responsible for strategic partnerships, team development, and representing the site in global best-practice initiatives. Applicants for this role at The Company should have a Bachelor's degree in a relevant field or at least 10 years' equivalent experience in a regulated manufacturing environment. A minimum of 7 years in Quality, Quality Engineering, or Manufacturing Operations within life sciences, biotechnology, medical devices, biopharma, or another FDA/EPA-regulated environment is required, with a preference for those with at least 5 years' leadership experience. The ideal candidate will have a strong knowledge of ISO 9001 & ISO 13485, FDA regulations, cGMPs, and CFR requirements, as well as proficiency in quality statistical methods, Lean Manufacturing, Six Sigma, and other quality improvement tools. The role demands a proven track record in leading, coaching, and mentoring teams, and the ability to communicate effectively at all levels.
Functions
- Operations
- Engineering
Vacancy posted 2 days ago
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