Sterility Assurance Senior Manager

Alvotech is currently hiring a Sterility Assurance Senior Manager. This is a mid-level management role within the Sterility Assurance department, overseeing 5–10 direct reports, sitting between operational execution and technical/quality oversight. The manager receives feedback from routine operations, inspections, and projects, then plans and distributes work across shift teams in alignment with SA and Microbiology Experts and the Department Head.

Beyond team leadership, the role carries technical responsibilities, providing sterility assurance and microbiology expertise to ensure DS/DP manufacturing meets GMP standards, supervising documentation of the microbial control strategy from incoming goods through final product, and acting as an SME for deviations, CAPAs, and change controls. The manager also supports internal, regulatory, and client audits, and authors, reviews, and approves GMP documentation such as SOPs, batch records, protocols.

Key responsibilities:

• Manage 5-10 direct report, provide support and guidance.

• Receive, plan and distribute work based on feedback related to routine operations, inspections and projects to shift leads.

• Support and represent the Sterility Assurance department at designated operational meetings.

• Provide training and guidance to team on regulatory and SA topics.

• Align with Experts (SA and Micro) and Department Head on the scheduling of projects.

• Ensure robust documentation, and compliance with pharmacopoeial standards.

• Ensure training within the department is up to date to ensure business continuity.

• Contribute and supervise the documentation and management of microbial control strategy for DS and DP production processes from Incoming good to final product.

• Provide Sterility assurance and Microbiology expertise to operations to ensure manufacturing meets cGMP standards and regulatory expectations.

• Provides oversight to facility and quality systems state of compliance with internal requirements and appropriate regulations and participates in the development of action plans to correct deficiencies and improve quality processes.

• Provides microbial and aseptic expertise to lead and support EMI, Deviations, CAPAs and complaints related to DS and DP manufacturing.

• Supports site internal inspections, Regulatory and Client audits.

• Author/review/approve GMP documents including but not limited to SOPs, batch records, protocols, reports and specifications.

• Be an SME author of deviations, CAPAs and change controls relating to sterility assurance and microbiology as required in span of expertise.

• Responsible for own continuous professional development to maintain up-to-date knowledge of new regulatory requirements as well as technical developments relevant to own area of expertise. Proactively share knowledge for the benefit of others.

• Accountable for ensuring quality metrics and KPIs are maintained in control for areas of responsibility.

• Responsible for handling and support of Environmental Monitoring and Personnel Monitoring excursion investigations.

Qualifications:

• Minimum 5-7 years of experience in Sterility Assurance/Microbiology.

• Detailed knowledge and experience of working to cGMP standards within Biologics/ parenteral manufacturing for aseptically produced drug products.

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 well-being 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.