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.

Vinnustaðurinn

Director of Intelligence & Knowledge Management

We are seeking a highly skilled and experienced professional to join our Quality Unit team as the Director of Intelligence & Knowledge Management. In this role, you will be responsible for developing and executing a regulatory intelligence strategy to monitor global trends and ensure compliance with Good Manufacturing Practices (GMP). You will implement and manage knowledge management systems, ensuring adherence to all applicable provisions of the Quality Management System, Health Authority regulations, FDA, EMA, Health Canada, and other regulatory standards.

Helstu verkefni og ábyrgð

Develops and executes a regulatory intelligence strategy to monitor global trends and ensure compliance with GMP.
Implements and manages knowledge management systems.
Ensures compliance with all applicable provision of the Quality Management System, the Health Authority regulations, FDA, EMA, Health Canada, and other regulatory standards.
Ensures that the team Proactively performs the search/review for all Pharmacopeial revisions and updates to Regulatory Requirements, Guidance documents and best practices across all applicable Health Authority Agencies.
Researches and communicates emerging regulatory subjects within the organization.
Leads improvement initiatives for practices, processes, and quality.
Facilitates cross-functional collaboration and manage projects.
Helps establish and maintain departmental metrics.
Participates in CAPA management, audits, inspections, and other quality projects.

Menntunar- og hæfniskröfur

University Degree (BS/MS) in in pharmacy, biotechnology, biochemistry, chemistry, biology, or related fields.
Minimum of 5-10 years of experience in Pharmaceutical or Biopharmaceutical sector.
Strong knowledge and experience of GMP standards (FDA, EMA, Health Canada and other), quality systems, practices and regulations.
Experience in GMP compliance: regulatory intelligence, knowledge management.
Strong interpersonal, communication and organizational skills.
Strong problem solving and decision-making skills.
Ability to work effectively in a fast-paced dynamic environment with changing priorities and deadlines.
Excellent oral and written communication skills and strong interpersonal skills

Fríðindi í starfi

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.

Auglýsing birt24. mars 2025

Umsóknarfrestur7. apríl 2025

Tungumálahæfni