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MST Compliance Support Specialist

Alvotech · Reykjavik

New
🇬🇧 English

Job description

About the role

Alvotech is seeking an experienced MST Compliance Support Specialist to join its Manufacturing Science & Technology team. The role will oversee quality events, investigations, CAPAs and change controls, ensuring timely resolution and regulatory compliance across manufacturing operations.

Key responsibilities

  • Lead and establish quality record and event management strategies for MST, including change controls, investigations, deviations and CAPAs.
  • Monitor, track and drive timely progression and closure of quality events based on priority and criticality.
  • Standardize quality event management processes and promote a harmonized approach across MST teams.
  • Act as the primary compliance liaison within MST and collaborate with Operational QA and external quality teams.
  • Represent MST in governance review boards such as deviation, complaint, investigation and control strategy forums.
  • Support regulatory inspections, quality audits and due‑diligence activities.
  • Review MST documentation to ensure compliance with cGMP, internal procedures and regulatory expectations.
  • Contribute to SOP, training material and controlled documentation development and revision.
  • Provide oversight of outsourced MST activities and maintain compliance visibility across sites and partners.

Required profile

  • Bachelor’s or Master’s degree in Biotechnology, Life Sciences, Pharmacy or a related scientific discipline.
  • 5+ years of experience in Quality, Compliance or related roles within the biopharmaceutical industry.
  • Robust experience authoring scientific and Quality Management System documents.
  • Excellent stakeholder management, communication and cross‑functional collaboration skills.
  • Ability to work independently, manage multiple priorities and drive compliance initiatives in a dynamic environment.

What we offer

  • Opportunity to work on ambitious projects that improve patients’ lives.
  • Being part of a fast‑growing global biotechnology company.
  • International work culture that values diversity, collaboration and inclusion.
  • Positive, flexible and innovative work environment.
  • Support for personal growth and internal career development.
  • Company social events, milestone celebrations and excellent in‑house canteen.
  • Exercise and wellbeing support, on‑site shower facilities and transportation grant for eco‑friendly travel.
  • Internet access at home for full‑time employees.

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Published 20 klukkutímar síðan

Expires 1 mánuður síðan

4 views · 0 interested

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Alvotech

Reykjavik