Quality Assurance Specialist
Are you a Quality Assurance expert looking for the best of both worlds?
Would you like to work directly with a single sponsor while still enjoying the stability, global reach, and career development opportunities that come with working for a leading CRO? Our team calls it the best of both worlds, and we think you’ll agree.
ClinChoice, a fast-growing global contract research organization, is expanding its Quality Assurance team in the Netherlands. We’re seeking experienced Quality Assurance Specialists focused on the development, production and marketing of vaccines and antibodies to prevent and combat infectious diseases. Experience within quality and compliance for new products being developed and produced for clinical trials and early launch. Provide QA support for commercial and clinical production at the manufacturing site, serve as the main point of contact for all quality-related matters. Ensure GMP compliance, review manufacturing activities, and collaborate closely with internal teams and external partners across various departments and companies.
Are you interested in partnering with some of the world’s leading pharmaceutical companies in the field of biomedicine? If that sounds like you, we encourage you to submit your resume via our website. We're growing our network and would love to connect with you!
Main responsibilities include:
- Provide quality oversight for the AT production facility and ensure GMP compliance.
- Support GMP processes including change control, documentation, training, and inspection readiness.
- Offer QA guidance on facility/equipment design, tech transfers, validations, aseptic processing, and Annex 1.
- Review investigations, assess non-conformances, and approve CAPAs and product dispositions.
- Support and participate in risk assessments and lead GMP training initiatives.
- Promote a strong quality culture through activities such as GEMBA walks.
- Review and approve document changes and contribute to local/global quality projects.
- Optimize quality monitoring processes and tools.
- Act as QA representative during regulatory inspections and on-call support rotation.
- Partner with site teams to manage changes and mitigate compliance risks.
- Serve as a QA SME for audits, studies, and JBV (quality-related) projects.
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 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 i
Keywords: Senior Clinical Research Associate, Senior CRA, Freelance, Self-employed, Contract, Site Management, Monitor, Monitoring, Complex Trials, Medical Devices, Cardiology, Neurology, Open to Travel, Submissions, Ethics, Contract Research Organisation, CRO
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