Director of Data Integrity & Compliance

Overview of role:

Alvotech is seeking a highly experienced and visionary Director of Data Integrity & Compliance to lead the development, implementation, and oversight of our data integrity framework. This role is critical to ensuring the accuracy, reliability, and regulatory compliance of our data systems across the Reykjavík manufacturing facility. You will be a recognized thought leader, driving strategic initiatives and fostering a culture of integrity and innovation.

Key Responsibilities:

Strategic & Operational Leadership

• Set tactical direction and develop operations within the Engineering & CSV department.
• Provide strategic input to Quality Systems goals and influence organizational standards.
• Interpret and adapt policy guidelines to align with evolving regulatory landscapes.

Data Integrity Governance

• Own and maintain the framework for data integrity across critical systems and processes.
• Lead the development of DI policies, procedures, and compliance strategies aligned with FDA, EMA, GMP, GAMP, and PIC/S standards.
• Conduct DI audits, risk assessments, and implement mitigation strategies.

Compliance & Quality Oversight

• Maintain regulatory intelligence and ensure site-wide DI compliance.
• Support internal and external audits, inspections, and regulatory assessments.
• Guide the selection and validation of DI-compliant systems and tools.

Training & Culture Building

• Develop and deliver DI training programs across all levels of the organization.
• Promote a culture of accountability, innovation, and continuous improvement.

Qualifications:

• Education: Bachelor’s degree in a scientific or technical discipline (advanced degree preferred).
• Experience: 8–10+ years in data integrity management within the pharmaceutical or biotech industry.
• Expertise:
• Deep knowledge of FDA, EMA, GMP, GAMP, and PIC/S standards.
• Proven success in implementing DI controls and managing regulatory inspections.
• Strong understanding of data management and laboratory information systems.
• Exceptional leadership and cross-functional collaboration skills.
• Analytical mindset with strong problem-solving abilities.
• Excellent communication and interpersonal skills.
• Ability to influence change and drive strategic initiatives.

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.