Senior Microbiology Quality Leader

Baxter Healthcare; Naperville (IL); On-site; USD 136,000 - 187,000; Full time

Benefits offered by this job

Medical and Dental benefits

401(k) plan

Paid time off

Job summary

Baxter is seeking a Senior Quality Manager in the United States to lead microbiology testing across raw materials and finished products. The role centers on building and coaching a supervisory team, ensuring GMP/GLP compliance, and driving timely deviation investigations and corrective actions.

You will collaborate with cross-functional teams, participate in audits (FDA), monitor KPIs, and push continuous improvement initiatives while managing budgets and training programs.

Qualifications

• Bachelor's degree in Science, concentration in Biology or Microbiology, preferred.
• Minimum 10 years professional experience in Quality, Manufacturing, Engineering or related field.
• Minimum 7 years confirmed experience in cGMP related industry.
• Minimum 5 years proven leadership/supervision and experience within an aseptic or sterile manufacturing site.
• Knowledge of microbiology testing techniques, including bioburden, endotoxin, solution particulate matter detection, and microbial identification.
• Familiarity with regulatory requirements including USP, FDA, and ISO standards.
• Demonstration of leadership, communication, and interpersonal skills.
• Strong analytical and problem-solving skills.

Responsibilities

• Develop a team of supervisors and/or department leads involved in microbiology testing of raw materials and finished good products.
• Supervise product testing procedures for bioburden, microbial identification, endotoxin, and solution particulate matter.
• Ensure compliance with Good Manufacturing Practice (GMP) and Good Laboratory Practice (GLP) and other relevant regulations and standards.
• Coordinate with cross-functional teams to address testing requirements and timelines in support of change controls, protocols, and engineering studies.
• Collaborate with Quality Assurance to achieve timely resolution of deviations, investigations, and corrective actions related to areas of responsibility.
• Participate in internal and external audits, including direct interfacing with regulatory agencies such as FDA.
• Remain informed about industry trends, regulatory changes, and emerging technologies related to microbiology testing.
• Develop, maintain, and establish action plans as needed for Key Performance Indicators (KPIs) and Metrics to maintain and improve the efficiency and effectiveness of product testing processes.
• Identify and lead continuous improvement projects with the objective of achieving quality, reliability and cost improvements.
• Develops and ensures adherence to budget and reports on overspend as necessary to evaluate reason and possible corrections.
• Manages the coaching, training and development process of subordinates.
• Sustain a clean and safe work area using 6S principles.

Skills

Leadership

Communication

Problem-solving

Analytical skills

Regulatory knowledge

Education

Bachelor's degree in Science (Biology/Microbiology)

Job description

Baxter is seeking a Senior Quality Manager in the United States to lead microbiology testing across raw materials and finished products. The role centers on building and coaching a supervisory team, ensuring GMP/GLP compliance, and driving timely deviation investigations and corrective actions.

You will collaborate with cross-functional teams, participate in audits (FDA), monitor KPIs, and push continuous improvement initiatives while managing budgets and training programs.