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Sterility Assurance Lead, Galderma (Uppsala)

SallyQ AB · Uppsala · Heltid

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The roleWe call ourselves a 60-year-old startup. Decades of scientific heritage, paired with the speed, ambition and hands-on energy of a company being built from the ground up. Right now, we're scaling manufacturing fast, and that means the way we assure sterility needs to scale with it. We're looking for a Sterility Assurance Lead who wants to own that agenda from day one, not just maintain a system, but shape how sterility assurance grows alongside the site.You will own and drive the site’s sterility assurance strategy. This role ensures compliance with global regulatory requirements and serves as the SME for contamination control, aseptic processing, and sterilization validation.Key ResponsibilitiesLead the Sterility Assurance Program (SAP) and Contamination Control Strategy (CCS) in line with EU GMP Annex 1 and global standards.Oversee environmental monitoring, cleanroom qualification, and aseptic practices.Review sterilization validations and lead media fill programs.Drive contamination risk assessments, investigations, and CAPAs.Act as SME during audits and inspections.Provide training and mentorship in sterility assurance best practices.The role is based at Galderma's production site in Uppsala and requires on-site presence up to four days per week.Your ProfileYou are a highly motivated sterility assurance professional with a strong quality mindset and a passion for patient safety. You combine deep technical expertise with leadership capabilities and are comfortable acting as a site Subject Matter Expert. You're energized rather than unsettled by a fast-scaling environment, you bring a proactive, solution-oriented approach that lets you spot risks early, drive improvements, and push operational excellence forward even as priorities shift.You thrive in a collabor…
MikrobiologCell- och molekylärbiologer m.fl.