Specialist Clinical Quality Assurance

At
Polpharma Biologics Switzerland AG
, we are building something different – a biosimilar company defined by purpose, speed, and people. We own the full value chain, from product selection to global launch, making high-quality biologics more accessible worldwide. We are looking for a
Specialist Clinical Quality Assurance
to join our lean, empowered, cross-functional team. Reporting directly to the Head of Quality, you will support the implementation and maintenance of clinical quality systems in alignment with GCP standards.

Do you have knowledge of GCP requirements and a background in Clinical Quality Assurance? We are seeking a skilled professional with expertise in Clinical Quality Management Systems to support the oversight and assurance of the quality of clinical trials conducted within the scope of biosimilar development operations in Switzerland. If you have proven experience navigating clinical quality landscapes and a passion for ensuring compliance in cutting-edge biosimilar development, we encourage you to explore this opportunity.

Your responsibilities include, but are not limited to:

• Support overall life-cycle management of Clinical Quality Assurance documents (development or liaison with authors, review, release, roll-out, triggering of update/revision, retirement),
• Training management to support company approach for staff training by providing or coordinating training (eg. GCP, QA, Risk Management, QDs),
• Support the Quality Lead (primary quality point) for assigned projects,
• Support risk-based quality oversight and high quality standards for assigned projects,
• Supports the management or manage the audits of clinical study sites, vendors/ contractors, Polpharma Biologics internal systems/ procedures, and others as required. Monitors progress of audit and CAPA activities for assigned projects,
• Support inspection readiness activities for assigned projects
• Support Inspection preparation activities
• Follow and maintain the system for internal Non-Compliance identification, investigation, root cause analysis, CAPA, tracking, and close-out,
• Support the coordination of the GCP serious breach process,

What you bring:

• Minimum of 3 years of relevant experience in the Biotech/ Pharmaceutical Industry, specifically within GCP, clinical monitoring or equivalent and with at least 2 years in quality or compliance,
• Proven ability to work effectively in a team environment and matrix structure,
• Strong communication skills in multicultural, multi-lingual environments,
• Well organized and structured,
• Good knowledge of drug development
• Good knowledge of clinical research/development
• Good knowledge of ethical principles, pertinent regulatory requirements GCP,
• Good knowledge of Good Clinical Laboratory Practice (GCLP) and Good Manufacturing Practice (GMP) relative to clinical trials
• Strong technical writing skills (procedures, and reports)
• Fluency in English
• Proficiency in local languages desirable

What we offer:

At Polpharma Biologics Switzerland, we believe in working with care — for patients, partners, and each other. We empower every team member to own their work, unlock their potential, and shape the future of biosimilars with purpose. To support your well-being, growth, and sense of meaning, we offer a comprehensive range of benefits, including:

• Competitive package with base salary, bonus and fringe benefits
• Attractive pension plan with preferential savings and risk components
• Hybrid workplace model, with a nice office in Zug/Zurich Switzerland and home-office possibility
• An empowered team that enjoys driving our business forward together, and celebrates shared wins
• A purposeful industry association where we enlarge the access for patients in need with affordable solutions