Senior QA Associate – Quality Systems/CSV

Senior QA Associate – Quality Systems/CSV

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Merus is looking for a Senior QA Associate -Quality Systems/ CSV

The Quality Systems department at Merus ensures compliance and quality across all GxP processes and systems. They maintain and improve the Quality Management System, oversee computerized system validation, and ensure compliance with regulations and data integrity. The team collaborates with various functional areas to support regulatory compliance and drive process improvements.

Your Role:

In this role, you are responsible for the QA oversight on Computerized System Validation (CSV) activities for GxP systems at Merus, ensuring compliance with regulations and data integrity. You will be a strong contributor to the maintenance and development of Merus’ Quality Management System, ensuring the successful application of Quality and Regulatory Standards.

Your key responsibilities will include:

  • Quality oversight on CSV and Computerized System Lifecycle activities to ensure GxP computerized systems are and maintain properly validated
  • Quality assessment and approval of deviations, change controls, CAPA
  • Contribute to continuous improvements and the Regulatory Intelligence program to maintain and develop the Quality Management System and improve business processes
  • Identify, assess, and mitigate risks on data integrity (DI) in projects / data handling processes
  • Develop training material and train end users on QMS processes, CSV, and Data Integrity.

Areas of Support:
  • Collaborate and advise cross-functionally to ensure compliance and initiate process improvements
  • Support functional areas (Clinical, CMC, IT, Research) and develop necessary procedures and validation documents
  • Participate in the Regulatory Intelligence Program and assist in the Business Administration of Merus eQMS
  • Audit external parties and internal Quality Systems, focusing on – but not limited to- Computerized System Lifecycle Management
  • Supplier Qualification including review of Quality Agreements
  • Contribute to preparation and management of inspections as CSV/DI Expert and Quality Systems SME

Your Profile:

We are seeking a detail-oriented individual who excels in driving change and promoting a quality culture. The ideal candidate will have strong analytical and critical thinking skills, capable of managing multiple projects independently. Excellent communication skills and the ability to collaborate effectively at all levels are essential. Persuasiveness and a proactive approach to continuous improvement are key attributes.

Requirements

  •  At least 6 years of QA-related GXP working experience, within (bio)pharma
  • Master in life sciences
  • Knowledge of GMP and/or GCP
  • Solid experience in Computerized System Validation and Data Integrity principles in GMP and GCP
  • Experience with Project Management
  • Experience in Lean Six Sigma methodology
  • Fluent in English

Why Merus?

We offer a once-in-a-lifetime opportunity to work with some of the best and brightest in the biotech industry. As part of Merus, you’ll experience a steep learning curve from your very first day in the job. And you’ll get to interact with a great international team of people who love what they do! To top it all, we offer a competitive salary, flexible working hours, an excellent pension scheme, a company bonus and 30 days’ annual leave (based on a full-time position in the Netherlands). Most importantly, you’ll have the chance to help us close in on cancer – everything you do matters at Merus. 

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    Our Hiring Process

    Stage 1:

    Internal Review

    This means that we’ve received your application and are in the process of reviewing it.

    Stage 2:

    Initial Call

    We’ll set up a 15-minute phone call with our Internal Recruiter to discuss the details of this job opportunity and your own expectations of the role, as well as Merus as a company.

    Stage 3:

    1st Interview Phase

    During the 1st interview phase, we’ll set up an interview with your potential future manager. We’ll be looking to understand more about your experience, how that fits the role, and what makes you tick.

    Stage 4:

    2nd Interview Phase

    If things are still looking good, we’ll set up several short interviews with team members, peers, Management Team members (where relevant) and HR to make sure we are a good cultural fit. We do our best to plan these interviews on the same day, although on rare occasions they’ll take place on multiple days.

    Stage 5:

    Job Offer

    After positive evaluation from both sides, you will receive our job offer. Once you’ve accepted it, we will draw up the necessary paperwork. You will receive your contract within 3-5 working days and your onboarding process will start!

    Stage 6:

    Welcome

    We’re more than happy to welcome you to join Merus in our pursuit to close in on cancer!

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    Merus is an equal employment opportunity employer that does not discriminate on the basis of actual or perceived race, color, religious creed, national origin, sex (including pregnancy, childbirth, and related medical conditions), sexual orientation, age, ancestry, disability or perceived disability, qualified handicap, gender identity, military status, veteran status, certain criminal records, genetic information or testing, HIV testing, or any other characteristic protected by applicable federal, state or local laws (each, a "Protected Characteristic"). We are dedicated to this policy with respect to recruitment, hiring, placement, promotion, transfer, training, compensation, benefits, employee activities and general treatment during employment.

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