Galderma is looking for a Sterility Assurance Lead who 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 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.
Drive contamination risk assessments, investigations, and CAPAs.
Act as SME during audits and inspections.
Provide training and mentorship in sterility assurance best practices.
You are a highly motivated sterility assurance specialist 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 collaborative, cross-functional environment and can communicate complex technical topics clearly to both technical and non-technical stakeholders. You're confident leading investigations, mentoring colleagues, and driving initiatives that strengthen contamination control and aseptic manufacturing performance, and you see this growth phase as a chance to grow your own scope right along with it.
Requirements
Bachelor's or Master's degree in Microbiology, Biotechnology, Pharmacy, or another relevant life science discipline.
a minimum of 8 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 technical expertise in 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 communication and collaboration skills with the ability to influence cross-functional teams.
If you believe this can be a right career change for you, please send in an application as soon as possible. We are evaluating the application continuously so please do not wait to send in your application.
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 body's 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 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.
