Senior Lead, Microbiology & Sterility Assurance

About the role

Baxter is looking for a senior leader within Quality to provide technical and people leadership for its Cartago site's Microbiology and Sterility Assurance programs. As the site subject matter expert, you will influence quality decisions, regulatory compliance, risk management and sterilization strategies, lead a team of technical professionals and ensure microbiological controls and sterilization processes stay effective, compliant and aligned with global standards.

Key responsibilities

• Lead the site's Microbiology and Sterility Assurance programs in line with regulatory requirements, industry standards and Baxter quality expectations.
• Provide technical oversight of microbiological monitoring, including environmental monitoring, bioburden testing, bacterial endotoxin testing, microorganism identification and manufacturing area controls.
• Guide sterilization processes and validation, including radiation sterilization programs, routine monitoring, requalification, dosimetry and change assessments.
• Act as subject matter expert during regulatory inspections, customer audits, internal audits and technical reviews.
• Drive investigations, CAPAs, risk assessments and change control for microbiology, laboratory operations and sterilization.
• Develop and mentor a high-performing team, set priorities, strengthen technical capabilities and support career development.
• Analyze quality trends and risks through data analysis to maintain validated processes.

Required profile

• Bachelor's degree in Microbiology, Biotechnology Engineering, Life Sciences or a related scientific discipline.
• 5+ years of progressive experience in microbiology, sterilization, sterility assurance or quality laboratory operations in a regulated industry such as medical devices, pharmaceuticals or life sciences.
• 2+ years of leadership experience managing or supervising technical professionals.
• Hands-on experience with microbiological controls, environmental monitoring, bioburden testing, bacterial endotoxins and sterilization processes.
• Strong knowledge of regulations and standards such as ISO 13485, ISO 14971, ISO 11137 and medical device quality systems.
• Advanced written and spoken English.
• Experience leading investigations, risk assessments, root cause analysis, CAPA and quality decision-making.

Preferred qualifications

• Direct experience in the medical device industry.
• Expertise in radiation sterilization (E-Beam and/or Gamma).
• Experience supporting regulatory, notified body or corporate quality audits.
• Knowledge of validation and qualification, including process validation, equipment qualification, computerized systems validation and test method validation.
• Structured problem-solving methods such as 5 Whys, Fishbone or 8D.
• Data analysis tools such as Excel, Power BI or similar.
• Certifications in industrial microbiology, sterilization technologies, auditing or quality risk management.