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 Project Manager to join one of our partner companies, a large pharmaceutical company, leader in the field of biomedicines, where you will work office-based in Beerse, 1.0 FTE for 4 months.
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:
The QA Project Manager will be involved in interaction with multiple departments, involved in new automation projects and initiatives, allowing you to learn and contribute to enhance the processes to bring CAR-T to our patients. You will collaborate with colleagues who may be in different countries, fostering an international work environment.
Main Job Tasks and Responsibilities:
- Collaborate with the production and engineering teams to elevate the automation level by transforming paper-based documentation into electronic master batch records.
- Leading QA activities in MES (Manufacturing Execution Systems) projects including required validation execution and documentation.
- Provide quality assurance (QA) support to the MES CAR-T project team, ensuring the project meets customer specifications.
- Collaborate with project managers, developers and manufacturing teams to align on the quality and compliance requirements for MES applications.
- Review validation documentation including PQ protocols, tests, traceability matrices.
- Ensure MES solutions comply with GMP and other regulatory standards.
- Conduct risk assessments, deviation management and change control reviews.
- Participate in and support audits and internal quality reviews.
- Act as an expert resource in assessing and maintaining quality and compliance standards, including providing guidance and training to ensure adherence to regulatory requirements and standards.
- Possess the ability to grow as a yellow or green belt specialist in lean automation projects.
- Establish and maintain effective working relationships with the different business partner and Legend Biotech to ensure alignment of objectives and deliverables.
- Ensure the quality oversight of the operational activities by documented QA approval of GMP documentation and support in the different quality review meetings.
- Active participation in project teams, operational teams & system teams.
- Close collaboration with operations, IT & automation.
Education and Experience:
- Bio-Engineer, Pharmacist or a bachelor’s or master’s degree in a technical field (e.g., Engineering, Computer Science, etc.) with at least 2 years’ cross functional experience in pharmaceutical industry.
- Up-to-date knowledge and in-depth understanding of relevant pharmaceutical legislation related to cGMP regulations.
- Strong analytical thinking and decision-making skills.
- Experience with master batch records and/ or quality assurance in production environments is required.
- Experience with MES systems in production environments is a strong advantage.
- Strong communication skills and a solution-oriented attitude.
- Ability to work independently as well as in a team setting.
- Fluent in English and Dutch (spoken and written).
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 Assurance Project Manager, Quality Assurance, CAR-T, Manufacturing Execution Systems, GMP, CRO, Contract Research Organisation, Outsourced, Outsourcing, Sponsor-dedicated.
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