IMP QA Manager — Roche

Full description

At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters.

The Position IMP Quality Organization Switzerland is the quality partner for all production units (drug substance and drug product) of pharmaceutical technical development in Switzerland. It monitors all quality and GMP-relevant production processes of IMPs (Investigational Medicinal Products) used in clinical trials. We are looking for a passionate and competent Quality Manager for our team “IMP Quality Systems, Compliance and Training” in Basel/Kaiseraugst. In this role, you are an important partner who ensures the highest quality standards for investigational medicinal products (IMPs), supports our local PTD (Pharmaceutical Technical Development) teams and, as a key member, significantly promotes the maintenance and continuous improvement of our quality management system (QMS).

The possibility In this exciting position, the following main tasks await you:

• You take over QA oversight of critical quality systems to ensure their robustness and manage access rights for QMS users for smooth operations.
• You act as Business Process Manager (BPM) for QMS elements such as quality risk management, technical change management and deviation management.
• You report Key Performance Indicators (KPIs) from QMS metrics for data-driven decision-making in the Management Review of Quality (MRoQ).
• You will manage training assignments to ensure team competencies and establish quality agreements (QAGs) with external partners and other Roche locations.
• You will actively assist with regulatory inspections and internal audits and ensure strict compliance with cGMP requirements and Roche’s global quality guidelines.
• You will provide valuable technical and quality assurance input when reviewing and approving critical documents.
• You act as a subject matter expert (SME) and work in partnership with various stakeholders throughout the company.

Who you are

As a committed personality, you distinguish yourself through strong communication and team skills, a self-responsible working method and a high quality awareness and bring the following profile:

• A completed degree (BSc/MSc/PhD) in pharmacy, chemistry, life sciences, engineering or a related field.
• At least 2 years of professional experience in the pharmaceutical industry with a strong understanding of quality principles as well as proven knowledge in technical development, manufacturing, regulatory affairs or quality assurance.
• Excellent written and oral communication skills in English and German that allow you to interact effectively with diverse teams.
• A results-driven mindset with the ability to drive innovation, embrace change and successfully steer quality initiatives across all levels of the organization.
• Strong skills in collaboration and team development with practical experience in working across different cultures, countries, technical competencies and organizational levels.

Ready for the next step? We look forward to hearing from you. Apply now to discover this exciting opportunity!

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