Senior Specialist, Manufacturing Compliance

AtAlvotech, we are driven by a clear mission: improving lives by increasing access to high-quality, affordable biologic medicines. As we continue to grow globally, we are looking for a Senior Specialist, Manufacturing Operations (Control Operations) to join our team and play a key role in maintaining GMP compliance, manufacturing oversight, and continuous improvement across our operations.

If you thrive in a fast-paced GMP environment, enjoy problem-solving, and are passionate about quality and compliance, we would love to hear from you.

About the role:

As a Senior Specialist, Manufacturing Operations, you will serve as a key contributor to quality and compliance activities within our manufacturing operations. You will collaborate closely with cross-functional teams to ensureinspectionreadiness, drive investigations, and support operational excellence.

Key Responsibilities

• Lead and manage investigations, ensuringtimelyclosure of quality records in line with established KPIs.

• Handle and support investigations, CAPAs, effectiveness checks, and change controls, ensuringtimelycompletion and compliance with GMP requirements.

• Provideexpertisefor Environmental Monitoring (EM) excursions, collaborating with QC Microbiology and Sterility Assurance teams.

• Prepare Cell Bank Stability Plans and Annual Cell Bank Stability Reports.

• Perform audit trail reviews of manufacturing systems and support closure of audit reports.

• Provide technical oversight during manufacturing operations, troubleshootingissuesand reviewing quality documentation.

• Deliver GMP and GDP training and awareness sessionstomanufacturing personnel.

• Maintain and update operational procedures and system-related SOPs.

• Develop and analyze quality metrics,identifyingtrendsandsupportingrisk mitigation strategies.

• Track and manage quality records to ensure regulatory compliance.

• Maintaininspectionreadiness of manufacturing suites and equipment.

• Participate in risk assessments, root cause analyses, and implementation of effective corrective actions.

• Partner with Manufacturing, MSAT, QC, and QA teams to drive compliance and operational excellence.

• Contribute to continuous improvement initiatives that enhance quality, efficiency, and compliance.

Qualifications

• Bachelor’s or master’sdegree in chemistry, Biochemistry, Biotechnology, Pharmaceutical Sciences, or relatedfield.

• Minimum 5years experiencein Downstreammanufacuringroles.

• Strong understanding of GMP requirements within pharmaceutical or biopharmaceutical manufacturing environments.

• Excellent written and verbal communication skills in English.

• Exceptional organizational skills with a keen eye for detail.

• Proactive, solution-oriented mindset and strong collaboration abilities.
  

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,collaborationand 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.

• Transportationgranttowards eco-friendly modes of travel for full-time employees.

• Internet at home for full-time employees.
  

WhyAlvotech:

AtAlvotech, we are passionate about improving lives by increasing access to affordable biologics.We’repurpose-driven and committed to fostering an inclusive and diverse working environment that encourages curiosity,ingenuityand simplicity. We want our employees to feel inspired in their careers, challenged by interesting and meaningfulworkand empowered to succeed in an agileenvironment.

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’screate a healthier world together, through affordable biologic medicines.