MST Compliance Support Specialist
Alvotech · Reykjavik
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
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Alvotech
Reykjavik
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