Director QA and Qualified Person (QP)
Director QA and Qualified Person (QP)
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:
- 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:
Requirements:
- 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.
Our Offer:
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