Job Description

Hartmann Young has partnered with a leading global provider of innovative IVD solutions aimed at enhancing patient care through advanced testing technologies. With decades of industry experience, the company offers a range of products designed to improve lab efficiency and support clinical decisions by providing accurate and timely results.

As the QA/QS Department Lead, you will manage the activities of the Quality Assurance and Quality Systems teams within the Quality Group. Your role includes overseeing raw material management, batch reviews, product releases, and the company’s Quality Management System (QMS). You will ensure compliance with regulatory standards and lead initiatives to improve operational efficiency.

Responsibilities:

Oversee performance against business and customer metrics.
Lead process improvements within the Quality System.
Manage audits (internal and external), compliance, and CAPAs.
Report directly to the Head of Quality.
Supervise daily team activities and develop staff through training and mentoring.
Maintain compliance with GMP, GDP, and other regulatory standards.

Qualifications:

Bachelor's degree in a relevant field.
Extensive QMS experience, ideally in a medical device or regulated environment.
Line management experience and proven audit leadership (e.g., FDA, MHRA).
Strong leadership, communication, and problem-solving skills.
Fluency in additional languages and advanced IT skills, particularly in QMS

If this position is of interest to you, please reach out to me for a confidential discussion at: oskar.bednarczyk@hartmannyoung.com.

Hartmann Young

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