Sterility Assurance Lead
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Job Summary
Galderma is the emerging pure-play dermatology category leader present in approximately 90 countries. We deliver an innovative science-based portfolio of premium flagship brands and services that span the full spectrum of the fast-growing dermatology market through Injectable Aesthetics Dermatological Skincare and Therapeutic Dermatology. Since our foundation in 1981 we have dedicated our focus and passion to the human bodys largest organ - the skin - meeting individual consumer and patient needs with superior outcomes in partnership with healthcare professionals. Because we understand that the skin we are in shapes our lives we are advancing dermatology for every skin story.
We look for people who focus on getting results embrace learning and bring a positive energy. They must combine initiative with a sense of teamwork and collaboration. Above all they must be passionate about doing something meaningful for consumers patients and the healthcare professionals we serve every day. We aim to empower each employee and promote their personal growth while ensuring business needs are met now and into the future. Across our company we embrace diversity and respect the dignity privacy and personal rights of every employee.
At Galderma we actively give our teams reasons to believe in our bold ambition to become the leading dermatology company in the world. With us you have the ultimate opportunity to gain new and challenging work experiences and create an unparalleled direct impact.
Job Title:Sterility Assurance Lead
Location:Uppsala
Role Summary
We are seeking a Sterility AssuranceLeadto own and drive the sites 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 Responsibilities
Lead 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.
Drivecontaminationrisk assessments investigations and CAPAs.
Act as SME during audits and inspections.
Provide training and mentorship in sterility assurance best practices.
Requirements
Bachelors orMasters degree in Microbiology Biotechnology Pharmacy oranotherrelevant life science discipline.
812 years of experience in sterile manufacturing microbiology or sterility assurance within the pharmaceutical biologics or medical device industry.
Proven experience working in GMP-regulated environments and supporting regulatory inspections and audits.
Hands-on experience with contamination control strategies environmental monitoring programs and aseptic manufacturing operations.
Skills
Deep technicalexpertisein aseptic processing sterilization technologies (moist heat dry heat filtration) and microbial contamination control.
Strong knowledge of cleanroom operations HVAC qualification isolators/RABS and environmental monitoring systems.
Solid understanding of EU GMP Annex 1 requirements and familiarity with global regulatory expectations (FDA EMA PIC/S).
Experience performing risk assessments using tools such as FMEA HACCP or similar methodologies.
Strong analytical mindset with the ability to interpret data trends and drive continuous improvement initiatives.
Excellent documentation skills and a structured approach to problem-solving and investigations.
Strong communicationand collaboration skills with the ability to influence cross-functional teams.
Your Profile
You are a highly motivated sterility assurance professional with astrong qualitymindset and a passion for patient safety. You combine deep technicalexpertisewith leadership capabilities and are comfortable acting as a site Subject Matter Expert. You have a proactive and solution-oriented approach enabling you toidentifyrisks drive improvements and support operational excellence.
You thrive in a collaborative cross-functional environment andare able tocommunicate complex technical topics clearly to both technical and non-technical stakeholders. You are confident leading investigations mentoring colleagues and driving initiatives that strengthen contamination control and aseptic manufacturing performance.
Key Skills
- Administrative Skills
- Facilities Management
- Biotechnology
- Creative Production
- Design And Estimation
- Architecture
