Quality Assurance Manager

Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds….

ClinChoice, is searching for a Quality Assurance Manager to join one of our partner companies, a large pharmaceutical company leader in the field of biomedicines. The QA Manager is responsible for ensuring that quality standards are integrated into the review process when designing or managing equipment and facilities. The ideal candidate will have expertise in risk-based analysis to proactively identify and mitigate potential issues.

This is a contract role starting as soon as possible and running through December 31, 2025, with the possibility of extension. The position requires full-time onsite presence (5 days a week) during the training period, after which it transitions to a hybrid schedule: 3 days onsite in Beerse and 2 days remote.

ClinChoice is a global full-service CRO with a strong focus on quality, professional development and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client counter-parts. 

Main Job Tasks And Responsibilities:

• Ensure integration of quality standards and risk mitigation in asset management design reviews.
• Oversee compliance and approve qualification activities, documentation, and master data.
• Review and approve calibration, maintenance, and certification records.
• Manage and approve quality records, including change controls, investigations, corrections, and CAPAs throughout the lifecycle of facilities, systems, and equipment.
• Regulatory Compliance & Governance -Maintain up-to-date knowledge of international regulations and industry standards related to system qualification and data governance. Ensure all qualification activities comply with relevant guidelines, internal procedures, and registration requirements.
• System Qualification & Change Management - Participate in system introductions and change projects, ensuring qualification status is maintained throughout. Evaluate and approve system changes that could impact quality, compliance, or registration. Ensure all deliverables (e.g., SOPs, calibration records, maintenance plans) are implemented in the quality system.
• Document Review & Approval- Review and approve qualification documents (e.g., impact assessments, URS, DQ/IQ/OQ/PQ protocols/reports, traceability matrices), system-related procedures, calibration and maintenance records, certification documents, parameter lists, and validation master plans.
• Deviation & CAPA Management - Evaluate and investigate deviations related to system qualification, calibration, maintenance, and use. Ensure thorough root cause analysis and implementation of effective corrective and preventive actions (CAPAs).
• Audit Readiness & Representation - Prepare for regulatory and customer audits and act as the QA spokesperson.
• Always uses the appropriate cGxP and procedures.
• Reports incidents and deviations.
• Experience in quality and qualification methodologies

Education And Experience:

• Master Engineering, Pharmacy or equivalent degree.
• Senior level role with 5 years’ experience in the pharmaceutical industry.
• Strong knowledge of pharmaceutical legislation, cGMP regulations, and system qualification guidelines.
• Familiarity with manufacturing systems and processes.
• Skilled in analytical thinking, risk assessment, and effective communication.
• Proven ability to collaborate and work in cross-functional teams.
• Innovation-driven with a focus on process optimization.
• Fluent in Dutch and English (written and spoken)

The Application Process

Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step.  Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.

Who will you be working for?

About Clinchoice

ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific.           

Our Company Ethos

Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel the clear tools needed to manage both internal and client processes with the same methodology.   The success of these core values is evidenced by our below industry average turnover rates.

ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it.

Keywords: Quality Assurance (QA), Risk-Based Analysis, System Qualification, Equipment Qualification, Facilities Qualification, Asset Management Design Reviews, Calibration Records, Maintenance Records, Certification Records, Qualification Documentation, DQ/IQ/OQ/PQ Protocols, URS (User Requirements Specification), Traceability Matrix, Validation Master Plans (VMP), Periodic System Quality Reviews (PSQR), Change Control, Deviation Management, CAPA (Corrective and Preventive Actions), Audit Readiness

#Li-Vh1 #Li-Contract