Senior QA Associate - Quality Systems/CSV

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.

• 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. 😊

Equal Employment Opportunities

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.

Fraudulent Recruiting Activities

Please be cautious of scam recruitment offers claiming to be from Merus. Such scams may come from various sources, including unsolicited email using Gmail or other non-Merus email addresses or via text. These scams seek to obtain personal information or payment from victims by offering jobs that do not exist. If you have been the victim of such a scam, please report it to Internet Crime Complaint Center (IC3) if you are living in the US or report it to the police if you live in the Netherlands.