Head of Quality

Head of 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 compliant, robust, and continuously improving, with a strong emphasis on blending compliance, continuous improvement, and people development. The Senior Manager will also be responsible for strategic partnership and advocacy, team development, and performance, as well as leading audits, reporting, and risk management. Applicants for this role at The Company should have a Bachelor's degree in Science or Engineering, or at least 10 years' of equivalent experience in a regulated manufacturing environment. A minimum of 7 years' in Quality, Quality Engineering, or Manufacturing Operations within a relevant regulated industry is required, with a preference for those with at least 5 years' of leadership experience. The ideal candidate will have a strong knowledge of ISO 9001 & ISO 13485, FDA regulations, cGMPs, and CFR requirements, and be proficient in quality statistical methods, Lean Manufacturing, Six Sigma, Gage R&R, and Root Cause Analysis tools. The role demands a proven ability to lead, coach, and mentor teams, manage performance, and communicate effectively at all levels.

Functions

• Operations