MST Compliance Support Specialist

IS10 Alvotech hf; Bengaluru; On-site; INR 1,800,000 - 3,000,000; Full time

Job summary

Alvotech seeks an experienced MST Compliance Support Specialist to lead quality record and events management, ensure harmonized processes, and support audits across MST. The role focuses on change controls, CAPAs, deviations, investigations, and cross‑functional collaboration with external QA partners.

You will participate in internal review boards, maintain SOPs and training materials, and provide compliance guidance for global biopharmaceutical operations, reporting through established

Qualifications

• Greater than 5 years international experience in Quality and/or Compliance Management in Biopharmaceutical or related industries.
• Demonstrated scientific and alliance management skills.

Responsibilities

• Establish MST Quality Record and Events management strategy across MST.
• Oversight and tracking of Quality Events across MST with timely follow-up based on criticality.
• Standardization of Quality Record and Events management processes across MST.
• Cross Functional Collaboration for compliance queries/issues with external and operational QA.
• Represent MST in Product Quality Complaints Review Board, OOS and Deviation Review Board, Control Strategy Review Board.
• Support in quality audits and due diligence activities.
• Quality review of MST documents ensuring alignment with cGMP standards.
• SOP & Training Material Updates based on process changes and learnings.
• Cross-site matrix management and compliance overview of MST outsourced activities.
• Serving as the one point of contact for all MST compliance information.

Skills

Quality management

Compliance management

Cross-functional collaboration

Education

Bachelor's/Master's degree in a relevant discipline

Job description

Key responsibilities and minimum requirements according to job level

High level of independence and accountability for large projects and development within field. Performs variety of tasks of variable complexity. Takes part in large strategic projects. Challenges and decisions faced in the role are often non-precedent. Can have impact on large, important projects. Leading expert within field – guides and coaches' other employees.

Competencies required to fulfil the employee responsibilities and work assignments

An employee shall follow the job description that pertains to his/her position. In addition, an employee shall follow the SOPs that pertains to his/her position. An employee shall adhere to the company policies and procedures that are available on the Alvotech intranet – Alvocado.

Responsibilities of MST Compliance Support Specialist

• Establish MST Quality Record and Events (change control, manufacturing investigation etc.) management strategy, including specification and internal and external manufacturing related change controls


• Oversight and tracking of Quality Events (change controls, change actions, CAPA's, deviations, lab investigations) across MST, ensuring timely follow-up based on criticality and priority.


• Standardization of Quality Record and Events management processes- establishment and stanrdadization of the relevant processes and procedures and ensuring harmonized approach across the MST teams


• Cross Functional Collaboration - serve an alliance for compliance queries/issues with external and operational QA


• Represent MST in relevant review boards, e.g. Product Quality Complaints Review Board, OOS and Deviation Review Board, Control Strategy Review Board etc.


• Support in quality audits and due diligence activities


• Quality review of MST documents- Review MST reports against the relevant source documents and ensure alignment with cGMP strandards and internal compliance requirements


• SOP & Training Material Updates: Contribute to the revision and development of SOPs, training materials, and controlled documents based on process changes and campaign learnings.


• Cross-site matrix management and compliance overview of MST outsourced activities


• Serving as the one point of contact for all compliance related information and queries within MST


• Performing activities above and beyond their responsibilities as and when required

Minimum education and experience required for the role

Education: Bachelors/Master’s degree in a relevant discipline and direct industry experience or extensive experience in the pharmaceutical or biopharmaceutical sector.

Experience: Greater than 5 years international experience in Quality and/or Compliance Management in Biopharmaceutical or related industries. Demonstrated scientific and alliance management skills.

About Alvotech

At Alvotech, we are building a global biotechnology company with a clear purpose: to expand access to high-quality, affordable biologic medicines for patients worldwide. Our people are central to that mission. Across our global teams, we bring together expertise in science, manufacturing, quality and commercial operations to shape the future of biosimilars. We offer a dynamic, fast-moving environment where curiosity, initiative and ownership are encouraged. Rooted in Icelandic values and operating on a global stage, we value collaboration, diversity and integrity across everything we do. Our teams work on meaningful challenges, contribute directly to patient impact, and grow alongside the business. Whether you are at the start of your career or looking to take your next step, Alvotech offers the opportunity to do work that matters, in a company driven by purpose and scale.

If you do not see a role that matches your experience today, we still welcome general applications from individuals who share our ambition and want to help improve access to biologic medicines worldwide.

If you have any technical issues, please contact: [e-mail]