Quality Leader: GMP Batch Release & Qualified Person

Anotech; Belgique; On-site; EUR 120,000 - 160,000; Full time

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

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.