Director, Clinical Bioanalytics Quality

Om jobbet

We are seeking a strategic and experienced leader to oversee bioanalytical Quality within CMQ. The Director partners closely with Clinical & Medical Affairs (CMA) to ensure robust quality oversight, risk-based processes, and a high level of inspection readiness across all internal and external bioanalytical activities.

Key Responsibilities

• Develop and improve risk-based GCLP/GCP quality oversight and audit frameworks for all bioanalytical activities.
• Ensure timely execution of quality oversight plans and audit programs across clinical development.
• Lead Managers and Specialists within CMQ (solid or dotted line reporting).
• Review/approve procedures, plans, templates, agreements, and records related to qualification, validation, and calibration of laboratory systems and equipment.
• Act as Lead Auditor and oversee internal, external, and outsourced audits.
• Evaluate and monitor service providers throughout contracting and utilization.
• Partner with bioanalytics leads on complex investigations, CAPA follow-up, and change management.
• Consolidate study/program insights, identify trends, and inform CMQ/CMA leadership of systemic issues.
• Monitor regulatory developments, gather inspection intelligence, and support implementation of improvements.
• Support CMA and CMQ during inspections and partner audits; coordinate follow-up activities.
• Provide quality consultation, develop and deliver internal training, and represent CMQ in cross-functional settings.
• Deputize for the Head of CMQ in relevant strategic and operational initiatives.

Experience & Qualifications

• MSc in biomedical sciences or pharmacy; PhD strongly preferred.
• 10+ years' experience in bioanalysis of human samples in multinational clinical trials; biologics experience preferred; GLP experience beneficial.
• 5+ years' experience in Quality Assurance of bioanalytical labs, including auditing and electronic data review.
• 7+ years of significant involvement in regulatory inspections (EU, FDA, PMDA, MHRA).
• Excellent English communication, writing, and presentation skills.
• Demonstrated experience leading diverse, decentralized teams.
• Strong digital acumen; experience with process optimisation and AI/ML tools preferred.
• Hands-on experience with LIMS, and Veeva Quality & Clinical Vault systems.
• Solid understanding of EU/US biologics regulatory pathways and ICH/EMA guidance on clinical trials and bioanalytics.

What we offer:

• An inspiring challenge to work with great co-workers on ambitious projects that change people's lives.
• The chance to be a part of a global and fast-growing company.
• An international work culture that encourages diversity, collaboration and inclusion.
• Positive, flexible, and innovative work environment.
• Support for personal growth and internal career development.
• Company social events and milestone celebrations.
• Excellent in-house canteen and coffee house.
• Exercise and wellbeing support for full-time employees.
• On-site shower facility.
• Transportation grant towards eco-friendly modes of travel for full-time employees.
• Internet at home for full-time employees.

Why Alvotech

At Alvotech, we are passionate about improving lives by increasing access to affordable biologics. We're purpose-driven and committed to fostering an inclusive and diverse working environment that encourages curiosity, ingenuity and simplicity. We want our employees to feel inspired in their careers, challenged by interesting and meaningful work and empowered to succeed in an agile environment.

True to our Icelandic roots, we also believe that integrity, gender equality, and fairness are foundational. We strive to bring together the brightest minds regardless of backgrounds and beliefs, to deliver to our partners and patients around the world. Let's create a healthier world together, through affordable biologic medicines.