Quality Control Analyst – Equipment Life Cycle Management (ELM) 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 Control Analyst III – Equipment Life Cycle Management (ELM) Specialist to join one of our partner companies, a large pharmaceutical company leader in the field of biomedicines located in Leiden, 1.0 FTE, until 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 need to be able to lead multiple projects, organize activities, prioritize, and maintain clear line of communication within the multidisciplinary (project) teams. Data integrity, mapping data flow, setting up and maintaining computerized systems are examples of ELM activities in support of well-functioning laboratories. You will also contribute to maintaining cGMP compliance and support the LEAN status of the team.

 

Main Job Tasks and Responsibilities:

• Lead end-to-end implementation of lab systems across teams, from standalone analytical equipment to global platform projects.
• Be responsible for multiple multidisciplinary equipment introduction, relocation, requalification and decommissioning projects concurrently, from initiation to closure.
• Define project scope, budgets, resourcing, planning, and stakeholder management, and monitor execution to meet agreed timelines.
• Document and standardize administrator, installation, and maintenance procedures; ensure compliance with USP, GAMP, GMP, and ERES.
• Collaborate on Lab Systems initiatives with the global organization and maintain the equipment validation master plan (inventory, qualification status, and related data).
• Engage with vendors to understand and implement new technology versions, ensuring reliability and performance, while coordinating internal and external communications during implementation.
• Involved in maintaining the equipment validation master plan for QC equipment (inventory, qualification status, additional information as required).
• Engages with equipment vendors to understand and implement new versions of technology in service of improving reliability and performance.
• Oversees communication between internal and external parties during the analytical equipment implementation process.

NC/CAPA process responsibilities:

• Support efficient and effective investigation training/certification. Support NC/CAPA system and process user training
• Facilitate the initiation of investigations and CAPAs and monitor progress and approvals.
• Collaborate with key stakeholders to support the end-to-end NC/CAPA process.
• Facilitate initiation of investigations and CAPAs and monitor progress to ensure timely completion.
• Execute quality reviewer/approver duties, review evidence, and approve closure of NC and CAPA records.
• Monitor CAPA effectiveness and confirm root cause is eliminated or reduced to an acceptable level.
• Collaborate with stakeholders, site owners, governance bodies, and senior management to resolve issues and align on corrective actions; escalate risks or compliance issues to the Senior Manager, Quality Systems CAPA as needed.
• Ensure the IMSC NC/CAPA process remains inspection-ready and support audits/inspections.
• Provide coaching and actionable feedback to issue owners on CAPA best practices, system usage, and investigation execution.
• Participate in and/or support internal audits and regulatory inspections, as needed.

 

Education and Experience:

• Master’s degree or bachelor’s degree (HBO) in Life Sciences or highly experienced in a similar position.
• Proven work experience in Pharma with GMP and automation skills.
• Pro-active, works independently, takes actions in the absence of specific instructions, and can write protocols/reports, business correspondence, and procedures.
• Proven Project Management skills and experience.
• Experience in budgeting, resourcing, planning, and leading projects.
• Laboratory Experience is considered a plus.
• A background with experience with (Computer) System Validation in a GxP environment is considered a plus.
• Experience with the following softwares is considered a plus: Empower, Softmax pro, SDMS, Deskman, LIMS, 32Karat, Trackwise, Comet and KNEAT.
• Ability to engage with personnel at all levels within the organization, to build and maintain fruitful relationships.
• Written and oral communication skills in English. Dutch is desirable.
• Planning skills, ability to prioritize multiple commitments
• Analytical thinking and (technical) problem-solving. Lean/Six Sigma experience is desirable.

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, Equipment Life Cycle Management, Quality systems, CAPA, GMP, Audit, CRO, Contract Research Organisation, Outsourced, Outsourcing, Sponsor-dedicated.

#LI-CM1 #LI-CONTRACT