Director, Global Microbiology
Director, Global Microbiology
Round Lake, IL
Baxter provides a broad portfolio of essential renal and hospital products, including home, acute and in-center dialysis; sterile IV solutions; infusion systems and devices; parenteral nutrition; surgery products and anesthetics; and pharmacy automation, software and services.
The company’s global footprint and the critical nature of its products and services play a key role in expanding access to healthcare in emerging and developed countries.
Baxter’s employees worldwide are building upon the company’s rich heritage of medical breakthroughs to advance the next generation of healthcare innovations that enable patient care.
- Responsible for designing and delivering global microbiology strategies while ensuring harmonization, patient safety, etc.
- Responsible globally for development, management and trending Environmental Monitoring (EM) program
- Provide coaching to other functions/sites in using problem solving structured approach
- Support and lead risk reduction and continuous improvement initiatives in line with company strategy
- Support and lead problem solving investigations for product and process deviations or customer complaints
- Responsible for deviations investigation and documentation associated with Corrective and Preventive Actions
- Proactively identify and escalate opportunities for risk reduction and Continuous Improvement
- Act as Change Leader for key projects
- Oversight of microbiology laboratory in routine and non-routine product testing and environmental microbiological testing
- Perform microbiological validations as needed for products and processes
- Ensure products and processes comply with procedures and the principles of GMP
- Support and assist in internal and external audit program. Participation in regulatory and corporate / internal audits and performance of supplier audits (as required), including documentation review.
- Conduct training of Quality and Manufacturing personnel
- Development of quality system procedures, controlled documents and processes
- Risk Management of the quality system and processes
- Support facility projects including process development and quality improvement initiatives
- Ensure site-wide local systems are in compliance with Baxter and Regulatory requirements
- Compliance to Environmental Health & Safety (EHS) requirements
- Proven experience designing and delivering corporate global microbiology strategies
- Strong experience in compounding pharma knowledge working in a project based environment
- Have excellent inter-personal, organizational, leadership/management and communication skills
- Be a passionate advocate of quality as a discipline and continuous improvement
- Have experience in the use of quality improvement and problem solving tools (Failure Modes & Effects Analysis (F.M.E.A.), Capability Studies, Process Mapping, DMAIC, PDCA, etc) and the interpretation of data
- Have experience of critical equipment and process Change Control
- Have experience in microbiology and associated validations and processes
- Ability to lead teams globally and set standards for multiple sites and travel globally up to 50%
Education and Experience
- MS in Microbiology required / PhD in Microbiology preferred
- Minimum of 10 years’ experience in managing teams within a matrix organization and laboratory GLP/GMP management with increasing scope including global responsibility and quality assurance in multiple companies
- 7 years management experience
Equal Employment Opportunity
Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.
Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please send an e-mail to Americas_TTA@baxter.com and let us know the nature of your request along with your contact information.