MST Compliance Support Specialist

Overview of role:

At Alvotech, we are driven by a shared purpose: improving lives by increasing access to affordable biologic medicines worldwide. As a fast-growing global biotechnology company, we foster a collaborative, inclusive, and innovative environment where talented professionals can make a meaningful impact.

We are looking for an experienced MST Compliance Support Specialist to join our Manufacturing Science & Technology (MST) team. In this role, you will support MST quality and compliance activities by overseeing quality events, investigations, CAPAs, and change controls, while ensuring timely resolution and regulatory compliance. You will serve as the key compliance liaison, support inspections and audits, and drive standardized quality practices across the departments within Manufacturing, Science & Technology.
 

Key Responsibilities:

• Lead and establish MST quality record and quality event management strategies, including change controls, manufacturing investigations, deviations, CAPAs, and related processes.
• Monitor, track, and drive timely progression and closure of quality events based on priority and criticality.
• Standardize quality event management processes and ensure a harmonized approach across MST teams.
• Act as the primary point of contact for compliance-related matters within MST.
• Collaborate closely with internal stakeholders, Operational QA, and external Quality teams to resolve compliance issues and support business objectives.
• Represent MST in quality and governance review boards, including deviation, complaint, investigation, and control strategy forums.
• Support regulatory inspections, quality audits, and due diligence activities.
• Review MST documentation to ensure compliance with cGMP requirements, internal procedures, and regulatory expectations.
• Contribute to the development and revision of SOPs, training materials, and controlled documentation.
• Provide oversight of outsourced MST activities and maintain compliance visibility across sites and partners.

Required Qualifications

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

Preferred Skills

• Experience managing quality events, CAPAs, change controls, and investigations.
• Proven ability to influence stakeholders and lead compliance-related improvement initiatives.
• Strong analytical mindset with excellent problem-solving capabilities

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. 

Icelandic biosimilar company developing and manufacturing high-quality biologic medicines for global markets. Based in Reykjavik.

alvotech.com