Compliance Specialist

About The Role

We are seeking a dedicated and detail-oriented Compliance Specialist to support our biomanufacturing operations. This role is critical in ensuring that our manufacturing processes remain compliant with current Good Manufacturing Practices (cGMP) and regulatory expectations. The ideal candidate will have strong experience in compliance oversight, deviation investigations, and regulatory documentation within a biomanufacturing environment.

Key Responsibilities

• Lead investigations for deviations reported in Manufacturing.
• Own and manage Corrective and Preventive Actions (CAPAs).
• Assist in creating and reviewing Standard Operating Procedures (SOPs), risk assessments, and other technical documents.
• Trend deviations and identify areas for process improvement.
• Provide compliance oversight during biomanufacturing runs, including monitoring cGMP activities in Grade A, B, C, and CNC production areas.
• Troubleshoot and review/approve quality documents such as planned changes, deviations, and excursions.
• Track and support timely closure of Quality Records, ensuring compliance with KPIs for:Deviations (non-process, system/facility, utility-related)CAPAsChange controls and actionsEMIs (impact assessments and SME reviews)Effectiveness checks
• Review and approve batch records and maintain turnaround time metrics.
• Review facility-related risk assessments, EMI deviations, and environmental monitoring trend reports.
• Support the review of process logbooks and other GMP records.
• Ensure the manufacturing facility and equipment are inspection-ready at all times.
• Conduct routine facility walkthroughs to maintain compliance.
• Contribute to audits and interactions with regulatory agencies.

Qualification

• Degree or Diploma in a relevant scientific or technical discipline, or equivalent experience.
• 1-2 years in a compliance role within biomanufacturing (preferred).
• Experience supporting Pre-Approval Inspections (PAIs) and working with international regulatory agencies (e.g., FDA, EMA).
• Strong knowledge of regulatory guidelines (FDA, ICH, PIC/s) and their implementation.
• Familiarity with Drug Product (DP) operations is a plus.
• Expertise in cGMP compliance and associated documentation.
• Strong attention to detail and organizational skills.
• Ability to work independently and manage multiple priorities.
• Effective cross-functional collaboration and communication.
• Adherence to company policies, SOPs, and professional etiquette.

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.

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.