Senior Quality Manager, Microbiology & GMP

Zvh; United States; On-site; USD 136,000 - 187,000; Full time

Benefits offered by this job

Medical & dental coverage

401(k) Retirement Savings Plan

Employee stock purchase program (ESPP)

Educational assistance

Paid time off

Job summary

Baxter is seeking a Senior Quality Manager in the United States. You will lead microbiology testing and QA activities, ensure GMP/GLP compliance, and partner with cross-functional teams to drive continuous improvement and regulatory readiness.

The role emphasizes leadership, risk management, and data-driven decisions. The position supports a high-quality manufacturing environment with extensive interaction across quality, manufacturing, and regulatory affairs, and offers competitive compensation

Qualifications

• Bachelor's degree in Science with Biology/Microbiology focus.
• Minimum 10 years in Quality, Manufacturing, Engineering, or related field.
• Minimum 7 years in a cGMP-related industry with leadership/supervision.
• Experience in aseptic or sterile manufacturing sites is preferred.

Responsibilities

• Develop and lead a team of supervisors and department leads involved in microbiology testing of raw materials and finished 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 meet testing requirements and timelines for change controls, protocols, and engineering studies.
• Collaborate with Quality Assurance to resolve deviations, investigations, and corrective actions.
• Participate in audits, including interface with regulatory agencies such as FDA.
• Stay informed on industry trends, regulatory changes, and emerging microbiology testing technologies.
• Develop and manage KPIs and metrics to improve testing efficiency and effectiveness.
• Identify and lead continuous improvement projects for quality, reliability, and cost.

Skills

Leadership

Quality management

GMP/GLP knowledge

Regulatory standards (USP, FDA, ISO)

Analytical/problem solving

Communication skills

Education

Bachelor's degree in Science (Biology or Microbiology)

Job description

Baxter is seeking a Senior Quality Manager in the United States. You will lead microbiology testing and QA activities, ensure GMP/GLP compliance, and partner with cross-functional teams to drive continuous improvement and regulatory readiness.

The role emphasizes leadership, risk management, and data-driven decisions. The position supports a high-quality manufacturing environment with extensive interaction across quality, manufacturing, and regulatory affairs, and offers competitive compensation