Senior QA Systems Specialist

Senior QA Systems Specialist

Location: Groningen

Working mode: Fully on-site

Duration: Contract initially running until the end of 2026 with an opportunity for a contract extension

Hours: 32 hours per week (working across 3-4 days or reduced hours across 5 days)

The Senior QA Systems Specialist is 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.

roles and responsibilities

1. 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:

o Coordination of responses to audit observations

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

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2. 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:

o Training curricula development and maintenance

o Role-based training assignments

o 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.

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3. 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.

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4. Compliance & Inspection Readiness

• Ensure the site is continuously inspection-ready.

• Monitor regulatory updates and implement necessary changes.

• Provide guidance to departments on compliance expectations.

how to succeed

Education

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

Experience

• 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.

Skills

• 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.

benefits

This role offers a very competitive hourly rate. This contract will run initially until the end of 2026.

you are welcome here

Johnson & Johnson is working to create an inclusive environment where diverse backgrounds, perspectives, and experiences are valued and each and every one of our people feels that they belong and can reach their potential. No matter who they are.

about Johnson & Johnson

Caring for the world, one person at a time has inspired and united the people of Johnson & Johnson for over 130 years. As a skilled contractor, you’ll play a key part in the thinking, strategy, dynamism - and impact - of this iconic global healthcare company as they touch the lives of nearly a billion people every day. Contribute to the next healthcare breakthrough with your next project at Johnson & Johnson.

application process

We are looking to process the first round of applications within the next 2 working days.

We do not accept applications via email. 

Diversity, Equity & Inclusion

For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo.

We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences. That is why we are working to create an inclusive environment where diverse backgrounds, perspectives and experiences are valued and each one of our people feels that they belong and can reach their potential. No matter who they are. Diversity, Equity & Inclusion at Johnson & Johnson means “You Belong”.