Senior Director Quality

Alex Partners; Weert; On-site; EUR 90,000 - 130,000; Full time

Job summary

A leading healthcare organization in Weert is seeking a Global Director of Quality to manage and develop Quality Assurance and Control across multiple sites. The ideal candidate will have significant experience in an international cGMP environment and a senior management background. Strong knowledge of relevant regulations and a hands-on mentality are essential. This full-time role offers an opportunity to influence quality processes at a global level.

Qualifications

• Expert in quality relevant regulations (e.g., ICH Q7, 21 CFR parts 210 & 211)
• Experience in senior management position
• Experience in generating long-term strategic plans

Responsibilities

• Manage the Quality Teams of various sites in Netherlands, Prague, and US.
• Drive the development of global quality processes.
• Lead regulatory inspections and support internal audits.

Skills

Experience in an international cGMP environment

Data driven decision making

Hands on mentality

Job description

Direct message the job poster from Alex Partners

Director - GTM & Leadership Recruitment | SaaS & High-Growth Technology | EMEA

Our client is a leading European headquartered healthcare, manufacturing & services organisation that, having undergone significant organic and acquisitive growth, is seeking a Global Director of Quality to join and lead the business through its next stage of growth. Reporting into the COO, the newly appointed Global Director Quality will take full ownership managing and further developing Quality Assurance and Quality Control at a local and global level.

Key job responsibilities:

• Manage the Quality Teams of the different sites in Netherlands, Prague and US
• Drive the develop the global Quality processes and quality improvement programs
• Contribute to operational and strategic decision-making
• Ensure cGMP performance is measured through KPIs and compliance metrics
• Ensure compliance of global and site-specific quality systems with applicable laws and regulations and actual and future customer demands, including periodic review of this
• Lead regulatory inspections of health authorities and supports internal audits, and external audits from customers
• Control changes in processes to stay in compliance with laws and regulations, customer demands and product registrations

Qualifications

• Experience in an international cGMP environment
• Experience in a senior management position
• Knowledge of cGMP; expert in quality relevant regulations (e.g. ICH Q7, EU Eudralex Volume 4 regulations, 21 CFR parts 210 & 211, GAMP5, 21 CFR part 11)
• Experience in generating long-term strategic plans
• Hands on mentality, data driven decision making and result oriented
• Dutch languages skills would be preferable but not a perquisite

Seniority level

• Director

Employment type

• Full-time

Job function

• Quality Assurance
• Pharmaceutical Manufacturing and Hospitals and Health Care

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