Sterility Assurance Lead, Galderma (Uppsala)

SallyQ AB; Uppsala kommun; Sur place; SEK 1 100 000 - 1 550 000; Plein temps

Résumé du poste

SallyQ AB is seeking a Sterility Assurance Lead to own and shape the site's sterility assurance strategy from day one. You will act as the SME for contamination control, aseptic processing and sterilization validation within a fast-scaling manufacturing environment.

Based at our Uppsala site, you will drive SAP/CCS programs, oversee environmental monitoring and sterilization validations, and lead CAPAs. You will be on site up to four days per week, collaborating with cross-functional teams to

Qualifications

• Experience in sterile manufacturing environments.
• Proven ability to lead investigations and CAPAs.
• Strong documentation and data interpretation skills.
• Familiarity with EU GMP Annex 1 and global regulatory expectations.

Responsabilités

• Lead the Sterility Assurance Program (SAP) and Contamination Control Strategy (CCS).
• 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.
• Reside at the production site in Uppsala and be on site up to four days per week.

Connaissances

Sterility assurance

Aseptic processing

Contamination control

Environmental monitoring

GMP knowledge

Regulatory inspections

Formation

Bachelor's or Master's in Life Sciences

Description du poste

The role

We 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 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.
• Reside at Galderma's production site in Uppsala and be present on site up to four days per week.

Your Profile

You 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 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.
• 8–12 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.