Senior Quality Assurance Systems 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 Senior Quality Assurance Systems Specialist to join one of our partner companies, a large pharmaceutical company leader in the field of biomedicines, where you will work at Groningen office, until the end of December 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 position you will be responsible for managing and maintaining key Quality Systems with primary ownership of the Training System and coordination of external audits. This role ensures compliance with regulatory requirements, supports continuous improvement, and drives inspection readiness.

Main Job Tasks and Responsibilities:

External Audit Coordination

• Serve as the primary coordinator for external audits (e.g., regulatory authorities, notified bodies, customers).

• Plan, schedule, and manage audit activities across departments.

• Act as the main point of contact for auditors during inspections.

• Ensure timely preparation of audit materials (SMEs, documentation, facility readiness).

Lead audit response activities, including:

• Coordination of responses to audit observations

• Tracking and closure of CAPAs (Corrective and Preventive Actions)

Ownership of Training System

• Own and manage the site GxP Training System.

• Ensure all employees are trained and qualified in compliance with internal procedures and regulatory requirements.
Oversee:

• Training curricula development and maintenance.

• Training effectiveness evaluations.

• Ensure timely completion and tracking of training activities.

• Maintain training records in compliance with data integrity standards together with a Training Technician.

• Support onboarding and continuous training programs.

• Lead improvements and digitalization initiatives related to the training system.

Quality Systems Management

• Support and maintain QA systems aligned with GMP / ISO / regulatory requirements.

• Ensure QA System’s procedures are up to date.

• Participate in internal audits.

• Drive continuous improvement initiatives within QA systems.

Compliance & Inspection Readiness

• Ensure the site is continuously inspection-ready.

• Monitor regulatory updates and implement necessary changes.

• Provide guidance to departments on compliance expectations.

Education and Experience:

• Bachelor’s or Master’s degree in Life Sciences, Engineering, or related field.

• 5+ years of experience in Quality Assurance within a regulated manufacturing environment (pharmaceutical, medical device, or similar).

• Strong experience with external audits/inspections and training systems management.

• In-depth knowledge of GMP, ISO standards, and regulatory requirements.

• Strong organizational and project management skills.

• Excellent communication and stakeholder management abilities.

• Detail-oriented with strong problem-solving skills.

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 System Specialist, Quality Assurance, Quality systems, GxP, Training, CAPA, CRO, Contract Research Organisation, Outsourced, Outsourcing, Sponsor-dedicated.

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