Senior Microbiology Quality Leader – GMP/GLP

Baxter International Inc.; United States; On-site; USD 136,000 - 187,000; Full time

Job summary

Baxter International Inc. is seeking a Senior Quality Manager in the United States to lead microbiology testing oversight, ensure GMP/GLP compliance, and drive improvements across quality programs.

You will manage a team, coordinate with cross-functional groups, and interface with regulatory bodies including the FDA. The role requires extensive experience in cGMP environments, leadership capabilities, and deep knowledge of microbiology testing techniques.

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 GMP and 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 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

Quality management

Leadership

cgmp

Microbiology

Regulatory knowledge

Problem solving

Analytical skills

Communication

Education

Bachelor's degree in Science, Biology or Microbiology

Job description

Baxter International Inc. is seeking a Senior Quality Manager in the United States to lead microbiology testing oversight, ensure GMP/GLP compliance, and drive improvements across quality programs.

You will manage a team, coordinate with cross-functional groups, and interface with regulatory bodies including the FDA. The role requires extensive experience in cGMP environments, leadership capabilities, and deep knowledge of microbiology testing techniques.