Alvotech hf

Alvotech er fjölþjóðlegt hátæknifyrirtæki í fremstu röð, þar sem yfir 1000 starfsmenn af um 64 þjóðernum vinna að því að móta framtíðina á sviði líftæknilyfja og auka aðgengi sjúklinga um allan heim að hágæða lyfjum. Margir af færustu vísindamönnum landsins starfa hjá fyrirtækinu. Við leyfum fjölbreytileika, forvitni og frumkvæði starfsfólks að njóta sín. Við bjóðum aðlaðandi starfsumhverfi í stöðugri mótun og ögrandi verkefni. Alvotech tryggir að jafnrétti kynjanna til launa og frama nái til allra starfsmanna, hérlendis jafnt sem erlendis. Við viljum laða að okkur færasta fólkið á hverju sviði, án tillits til uppruna eða kyns. Með þessum hætti getum við best þjónað hagsmunum sjúklinga og samstarfsaðilum okkar. Vertu með okkur í að bæta lífsgæði fólks og auka aðgengi að hagkvæmum líftæknilyfjum.

About

Director of Data Integrity & Compliance

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.

Helstu verkefni og ábyrgð

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.

Menntunar- og hæfniskröfur

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.