QC Compliance Senior Specialist

Overview of role:

We are seeking a highly motivated and experienced QC Compliance Senior Specialist to join our Quality Control team. In this role, you will be responsible for ensuring compliance with GMP standards, supporting laboratory investigations, and driving continuous improvement initiatives. You will play a key role in preparing for audits and regulatory inspections, and in maintaining the integrity of our quality systems.

Key Responsibilities:

• Monitor and trend quality records including invalid assays, deviations, CAPAs, and change controls.
• Lead and support laboratory investigations (OOS/OOT/OOE) in accordance with established procedures.
• Act as a subject matter expert in the closure of quality records and compliance-related activities.
• Conduct compliance walkthroughs in QC laboratories and provide training on compliance topics.
• Prepare for, support, and follow up on internal and external audits.
• Initiate, support, and lead deviations, CAPAs, and change controls.
• Identify root causes and implement corrective actions.
• Update quality documentation and generate qualification/validation documentation.
• Review and complete laboratory documentation using Good Documentation Practices (GDP).
• Generate and monitor trending reports for quality metrics.
• Provide technical support and contribute to continuous improvement efforts.
• Ensure compliance with Alvotech’s EHS policies and GMP standards.

Qualifications:

• Technical education in a relevant scientific discipline or equivalent.
• Minimum of 10 years of experience in the pharmaceutical or biopharmaceutical industry.
• Strong knowledge of GMP, GDP, and regulatory compliance.
• Proven experience in leading investigations, CAPAs, and change controls.
• Excellent documentation, communication, and organizational skills.
• Ability to work independently and manage multiple priorities.

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.