Sterility Assurance Manager - Reykjavik (Iceland)

Alvotech

Full-time - Mid Level

About the position

The Sterility Assurance Manager will lead the Sterility Assurance team to achieve sterility assurance goals and develop processes that ensure high-quality sterility assurance. This role involves overseeing the strategic planning and implementation of the Sterility Assurance Program, providing expertise in microbial control, and ensuring compliance with international standards for aseptic processing. The manager will also mentor team members and support regulatory audits, contributing to the growth and success of the business.

Responsibilities

• Oversee the strategic planning and provide expertise for the development and implementation of the site Sterility Assurance Program.
• Oversee the documentation and management of the microbial control strategy for DS and DP production processes from incoming goods to final product.
• Provide oversight and sterility assurance expertise to operations to ensure aseptic processing meets international aseptic processing standards.
• Provide oversight to facility and quality systems' state of compliance with internal requirements and appropriate regulations and participate in the development of action plans to correct deficiencies and improve quality processes.
• Provide microbial and aseptic expertise to support EM, deviations, CAPAs and complaints related to aseptic and sterile processing.
• Support regulatory and client audits as sterility assurance and aseptic processing SME.
• Provide microbial and sterility expertise for GMP documents including but not limited to SOPs, batch records, APS protocols, validations and specifications.
• Oversee the Sterility Assurance team to ensure individuals and teams are engaged, motivated, enabled and empowered to achieve production support, testing plans and project timelines.
• Responsible for own Continuous Professional Development to maintain up-to-date knowledge of new Regulatory requirements and technical developments relevant to own area of expertise.
• Train, coach and mentor less experienced members of staff as a Trained Trainer.
• Be an SME author of Deviations, CAPAs and change controls relating to sterility assurance as required in span of expertise.
• Supervise or delegate supervision of all sterility assurance activities.
• Accountable for ensuring quality metrics and KPIs are maintained in control for areas of responsibility.
• Provide oversight and quality standards of sterility assurance of the Alvotech facilities (existing and future).

Requirements

• Minimum of an MSc in a relevant scientific discipline and direct industry experience or 5+ years' experience in pharmaceutical or biopharmaceutical sector.
• Knowledge and experience of working to cGMP standards.

Benefits

• 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.