Director QA and Qualified Person

Merus is seeking a Director QA / Qualified Person (QP) to oversee the quality assurance aspects of our biological products throughout their lifecycle. This role is crucial for ensuring compliance with GxP standards and regulatory requirements, thereby safeguarding the integrity and safety of our products. Positioned in a unique role as per EU legislation, you will be the end-responsible for the release of assigned Merus' products, making pivotal decisions that impact GxP operations.

Your Role:

As the Director QA / QP, you will provide strategic oversight and hands-on management across various phases of product development for selected products/clinical studies. Reporting to the Head of QA, and supported by a couple of direct reports, you will:

• Oversee and manage all project-related QA activities for assigned projects, ensuring timely QA support to product development activities and compliance with internal quality management system (QMS) and GxP requirements.
• Hold the end responsibility for the decision and approval on final product disposition as the Qualified Person, certifying batch release or rejection based on compliance with GMP.
• Evaluate quality-related events such as deviations, complaints, and recalls to determine product impact, making decisions on material acceptance or rejection.
• Maintain and update the Quality Systems in line with regulatory developments and company evolution.
• Lead GMP/GDP audits as the Lead Auditor, ensuring contractor operations comply with GxP, regulatory filings, and quality agreements.
• Act as a quality advisor, reviewing and approving project documentation, regulatory filings, and quality agreements.

Your Profile:

We are looking for a highly experienced and knowledgeable QA professional who can navigate complex regulatory environments with a strategic and proactive approach. Your ability to make critical decisions and lead quality initiatives will be key to your success in this role.

• A Master’s Degree in Pharmacy or Biosciences, PhD preferred, and eligibility for registration as a QP as defined in EU Directive 2001/83/EC.
• At least 10 years of relevant GMP work experience in the biotechnology or pharmaceutical industry, including substantial QA experience and at least 5 years in quality leadership.
• At least 5 years of experience as a QP, ideally for clinical products.
• Expert knowledge of GMP/GDP, with a good understanding of GLP, GCP, and up-to-date knowledge of pharmaceutical laws and legislation.
• Fluency in English, with excellent communication skills to interact effectively across all levels of the organization and with external stakeholders.
• Demonstrated leadership in managing quality assurance teams and projects, with a track record of maintaining high standards of compliance and integrity.

This role offers the opportunity to take on significant responsibilities within a dynamic environment at Merus, driving the quality assurance strategy that supports the delivery of innovative treatments. If you are committed to excellence in quality and regulatory compliance and seek a challenging role where you can make a substantial impact, we encourage you to apply.

Our Offer:

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! Most importantly, you’ll have the chance to help us close in on cancer – everything you do matters at Merus. 😊