Quality Control Manager

Anotech

Belgique

On-site

EUR 120,000 - 160,000

Full time

46 hours ago
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Job summary

Anotech, a subsidiary of ALTEN operating in the Benelux, seeks a Quality Control Manager/Qualified Person to lead on-site GMP, batch release and QA projects.

Reporting to the Pharmaceutical Affairs Director, the role combines regulatory compliance, people leadership and hands-on validation work across processes and analytical methods. The ideal candidate holds a Master’s in Pharmacy, QP certification, 8+ years’ experience and fluent Dutch and English.

Qualifications

  • Master's degree in Pharmacy/Pharmaceutical Sciences.
  • Valid QP certification/registration.
  • Minimum 8 years as a Qualified Person in pharma manufacturing.
  • Experience in batch release and quality systems.
  • Strong knowledge of GMP, GLP, CAPA, OOS investigations.
  • Experience in process validation, method validation and equipment qualification.
  • Demonstrated leadership and people management.
  • Fluent Dutch and English; French is a plus.
  • Ability to balance operational priorities with long-term quality objectives.

Responsibilities

  • Act as the Qualified Person (QP) for pharmaceutical manufacturing operations.
  • Ensure batch certification and release per GMP requirements and marketing authorizations.
  • Review and approve batch documentation and quality records.
  • Ensure products are manufactured, tested and released according to regulatory expectations.
  • Lead a multidisciplinary quality team and oversee deviations, CAPA, OOS investigations and complaints.
  • Coordinate internal and external audits and inspections; support regulatory inspections.
  • Lead site projects related to new products and processes; validate methods and equipment.
  • Maintain compliance with European regulations and monitor quality performance indicators.

Skills

Leadership
People management
Analytical thinking
Problem solving
Fluent Dutch
Fluent English
Regulatory awareness

Education

Master's Degree in Pharmacy or Pharmaceutical Sciences
Certified Qualified Person (QP)

Job description

As part of a leading healthcare and pharmaceutical organization operating across the Benelux region, we are looking for an experienced Quality Control Manager to join a pharmaceutical manufacturing site in Belgium.This position combines operational quality leadership, batch release responsibilities and the management of critical pharmaceutical projects. The successful candidate will play a key role in ensuring GMP compliance while supporting the development and implementation of new products, manufacturing processes and analytical methods.

Position Overview

Reporting directly to the Pharmaceutical Affairs Director, the Quality Manager & Qualified Person will act as the primary Quality representative on site and assume full QP responsibilities for pharmaceutical manufacturing activities.The position requires a strong combination of regulatory expertise, people management capabilities and hands‑on experience within a pharmaceutical manufacturing and quality control environment.

Key Responsibilities
Qualified Person & Batch Release

Act as the Qualified Person (QP) for pharmaceutical manufacturing operations.

Ensure batch certification and release activities are performed in compliance with GMP requirements and marketing authorizations.

Review and approve batch documentation and quality records.

Ensure all pharmaceutical products are manufactured, tested and released according to regulatory expectations.

Serve as the primary quality contact for regulatory and compliance matters.

Quality Management & Team Leadership

Lead, coach and develop a multidisciplinary quality team.

Oversee daily quality activities including deviations, CAPA management, OOS investigations and product complaints.

Promote a strong quality culture and continuous improvement mindset.

Coordinate internal and external audits and inspections.

Support regulatory inspections and ensure timely implementation of corrective actions.

Validation & Pharmaceutical Projects

Lead site pharmaceutical projects related to new products and manufacturing processes.

Support the transfer and validation of new analytical methods.

Oversee process validation, method validation and equipment qualification activities.

Ensure laboratory instruments and quality systems remain compliant and qualified.

Collaborate closely with manufacturing, quality control and corporate stakeholders.

Compliance & Continuous Improvement

Maintain full compliance with European pharmaceutical regulations and GMP standards.

Identify quality risks and implement appropriate mitigation plans.

Monitor quality performance indicators and support continuous improvement initiatives.

Work with local and international teams to align quality objectives with business priorities.

  • Master's Degree in Pharmacy or Pharmaceutical Sciences.
  • Valid Qualified Person (QP) certification/registration.
  • Minimum 8 years of experience as a Qualified Person within a pharmaceutical manufacturing environment.
  • Proven experience in batch release and pharmaceutical quality systems.
  • Strong knowledge of GMP, GLP, CAPA, OOS investigations and deviation management.
  • Experience in process validation, method validation and equipment qualification.
  • Demonstrated leadership and people management experience.
  • Strong analytical and problem‑solving skills.
  • Ability to balance operational priorities with long-term quality objectives.
  • Fluent Dutch and English required.
  • French would be considered a strong advantage.

If you are an experienced Qualified Person looking for a leadership role combining quality management, batch release responsibilities and pharmaceutical project activities, we would be delighted to hear from you.

A subsidiary of ALTEN, Anotech provides complementary expertise in project execution and operational engineering to optimize schedules, budgets, and quality. Specializing in high‑CAPEX energy projects, we support major clients throughout the entire project lifecycle, from strategic planning to deployment. With a presence in more than 30 countries, including Houston, the Netherlands, Dubai, Singapore, and Shanghai, we support in operating effectively in complex, multicultural environments, delivering large‑scale energy projects with efficiency and reliability.

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