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 at Leiden office, until the end of February 2027.

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 position you will acts as a quality expert and ensures quality oversight of company Advanced Therapies products and processes. Plays a crucial role in ensuring that company manufacturing operations meet the highest standards of quality and GMP compliance by supporting various base business activities needing quality assurance expertise. The Quality Assurance Specialist works in close collaboration with other local or global departments (Operations, Warehouse, QC, GET, MSAT and other site Quality teams).

 

Main Job Tasks and Responsibilities:

• Ensure quality oversight during new product introduction (GMP runs and PPQ runs).
• Ensure quality oversight during equipment qualification and performance qualification (IQ/OQ/PQ).
• 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 decide on product disposition.
• Ensures that appropriate corrective and preventive actions (CAPAs) are identified and implemented in response to investigations, especially those with potential impacts on product quality and patient safety.
• Escalates serious quality, compliance and /or GMP incidents to management and support (Global) escalation of issues, which have potential impact on the delivery of products to patients.
• Participates 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.
• Provides review and approval of various document changes and change controls.
• Executes Quality Aseptic Processing Oversight activities, verifying that operations are executed as supposed to and supports various Quality on the floor initiatives.
• Promotes improvement initiatives to set up , standardize and lean out QA processes within the team.
• Provides Site support for local or global projects as an SME or QA core team member.
• Engages in internal audits and inspections as an SME or in support functions.
• On a rotation basis is available for beeper duty on out office hours and if quality oversight is needed during manufacturing (e.g. QAPOP).

 

Education and Experience:

• Degree in science related subject and /or business-related area with more 4-6 years of experience in a GMP regulated environment (manufacturing, QA and/or QC) in a pharmaceutical company. Experience in a QA role for at least 2-4 years.
• Proven experience working with quality systems, ensuring compliance with industry standards, GMP principles and regulatory requirements.
• Knowledge of aseptic processing techniques and sterile manufacturing requirements is highly desired.
• Experience in methods such as Process Excellence, Co Think or Kepner-Tregoe is recommended.
• Strong written and verbal communication skills to effectively negotiate and interact with various stakeholders.
• Problem solving, analytical thinking and decision making capabilities.
• Highly organized, capable of managing multiple tasks in a team environment, and able to work effectively under minimal supervision while maintaining a positive attitude.
• Demonstrated proficiency in English both verbal and in writing. Dutch is preferred but not mandatory.

 

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.

 

Key words: Quality Control Analyst, Quality Assurance, Quality systems, Advanced Therapies, GMP, Audit, CRO, Contract Research Organisation, Outsourced, Outsourcing, Sponsor-dedicated.

#LI-CM1 #LI-TEMPORARY