Quality Assurance Specialist

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 Specialist to join one of our partner companies, a large pharmaceutical company leader in the field of biomedicines, where you will work in a hybrid model in Leiden, 1.0 FTE until July 2026.

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.  

Scope of the role:

In this role you will provide QA support to the commercial/clinical production at the Leiden/Sassenheim AT manufacturing site. Acts as the primary point of contact for all AT quality related topics within the site (i.e., production facilities and quality control labs). Provides Quality oversight to the manufacture of Drug Substances/Starting Materials in AT. Provides independent reviews and ensures that clear, pragmatic and quality driven advice is given regarding the state of GMP compliance. The experienced specialist QA works in close collaboration with other departments (Operations, QC, Warehouse, MAM, MSAT). Reports to Manager QA AT and works together with other specialists QA. Other internal contacts include colleagues, both at operational and managerial levels, and all departments within the manufacturing site. External contacts: Quality and Non-Quality representatives within the IMSC companies.

Main Job Tasks and Responsibilities:

• Provides Quality oversight to the AT Production facility at the site. 
• Supports setting the GMP standards and/or provides Quality guidance for:
  • all GMP processes, e.g., Change Control, Doc Control, GMP Training, inspection readiness
  • Facility, utility, and equipment design for e.g., the new Pollux Facility
  • Technology and/or Analytical Transfer
  • Qualifications and Validations
  • Aseptic Processing and Annex 1 adherence
• Assess and review the outcome of Quality Investigations, provide support as part of the investigation teams and monitor the quality of the Root Cause investigations. Assesses non-conformances for possible impact on product quality or compliance status and decides on product disposition.
• Provide Quality support for the development of appropriate Corrective and Preventative actions and provides Quality approval.
• Escalate serious quality, compliance and /or GMP incidents to Site or Global Management and support (Global) escalation of issues, which have potential impact on the delivery of products to patients.
• Participate in Hazard / Risk assessments to ensure compliance or quality is not jeopardized.
• Coordinates, reviews, and provides GMP training (e.g., Non-conformances, Investigation techniques, Qualifications etc.) for site colleagues to ensure compliance to cGMP and company training requirements.
• Involved in initiatives that lead to a higher quality and compliance culture throughout the organization, including GEMBA walks in manufacturing areas and the laboratory.
• Provide review and approval of document changes and change controls.
• Lead or act as member for local or global capacity/quality projects.
• Optimize current and identify new ways of process and quality monitoring.
• On a rotation basis is available 24/7 as QA representative for Quality issues.
• Act as quality SME and participates in the preparations for (APR, Inspection readiness reports) and during inspections (FDA, EMA etc.) to accomplish a successful audits.
• Partner with site colleagues to ensure all site changes (e.g., to production processes, equipment, and systems) are conducted in a controlled and systematic manner and conform to cGMP and other regulatory requirements.
• Leads and supports facility in identifying and eliminating compliance risks.
• To act as a quality representative and provide expertise to manage and participate in JBV projects to ensure compliance to cGMP and company quality requirements.
• Assess, review, and approve study protocols and reports to assure that studies will be executed in a controlled and systematic manner conform cGMP and regulatory requirements e.g., but not limited to stability, validation, analytical technical transfer.
• Act as member in Quality Risk Management and /or root cause investigation sessions.

Education and Experience:

• Bachelor’s degree or higher in Biochemistry, Biology, Pharmaceutical degree or relevant education.
• Depending on education, BSc 6 years and for MSc 4 years of experience in a GMP regulated environment (manufacturing, QA and/or QC).
• Experience in methods such as Process Excellence, Co Think or Kepner-Tregoe is recommended.
• Proven knowledge of the biotechnological/pharmaceutical industry.
• Proficiency in English both in word and in writing.
• Deep understanding and application of Global Regulatory (cGMp/ICH/FDA/EMA) guidelines in Operations environment.
• Functions independently in a complex environment to make daily judgments to balance business need, regulatory requirements, and cost efficiency for all Quality decisions. It is required to determine the level of risk, magnitude and/or complexity in order to make sound judgment on when to escalate critical issues to Quality management.
• Broad knowledge of QA systems (i.e., change control, deviation management, cGMP, validation) manufacturing and laboratory processes, facilities and utilities and technical automation.
• Problem solving and troubleshooting to initiate fresh, innovative, and compliant solutions to manage unexpected quality issues.
• Ability to drive collaboration in a fast-paced environment.
• Has good negotiation skills with a customer-oriented attitude. Influences (without formal authority) and engages colleagues throughout the site and manages diversity and conflicting viewpoints.
• Empowered professional who can make well motivated pragmatic decisions on their own.

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 a 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.

Key words: Quality Control Specialist, Quality Control, GMP, CAPA, , Laboratory, CRO, Contract Research Organisation, Outsourced, Outsourcing, Sponsor-dedicated.

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