Senior Quality Manager, Microbiology & GMP Excellence

Baxter International Inc.; Marion (NC); On-site; USD 136,000 - 187,000; Full time

Benefits offered by this job

Health insurance

401(k) plan

Paid time off 20–35 days

Employee stock purchase plan (ESPP)

Job summary

Baxter International Inc. is seeking a Senior Quality Manager to lead microbiology testing oversight and ensure GMP/GLP compliance across the Quality organization. You will mentor staff, coordinate with regulatory affairs, and support FDA audits while driving improvement initiatives.

The role emphasizes aseptic manufacturing, leadership, and a strong focus on quality, reliability, and cost efficiency in both plant and office environments.

Qualifications

• Bachelor’s degree in Science, concentration in Biology or Microbiology.
• 10+ years in Quality, Manufacturing, Engineering or related field.
• 7+ years confirmed experience in cGMP related industry.
• 5+ years proven leadership in aseptic or sterile manufacturing.
• Knowledge of microbiology testing techniques (bioburden, endotoxin, particulate matter, microbial ID).
• Regulatory familiarity with USP, FDA, ISO standards.
• Strong leadership, communication, and interpersonal skills.
• Excellent analytical and problem-solving abilities.

Responsibilities

• Develop a team of supervisors/department leads for microbiology testing of materials and finished goods.
• Supervise testing procedures for bioburden, endotoxin, and particulate matter.
• Ensure GMP/GLP compliance and other relevant standards.
• Coordinate with cross-functional teams to meet testing requirements and change controls.
• Collaborate with QA to resolve deviations, investigations and CAPAs.
• Participate in internal/external audits, including FDA interactions.
• Stay informed on industry trends and regulatory changes in microbiology testing.
• Lead KPIs and cost/quality improvement initiatives.
• Develop and manage budgets and training of subordinates.
• Maintain a clean, safe 6S workplace.

Skills

Leadership

Supervision

Communication

Interpersonal skills

Analytical skills

Problem solving

Education

Bachelors in Science (Biology or Microbiology)

Job description

Baxter International Inc. is seeking a Senior Quality Manager to lead microbiology testing oversight and ensure GMP/GLP compliance across the Quality organization. You will mentor staff, coordinate with regulatory affairs, and support FDA audits while driving improvement initiatives.

The role emphasizes aseptic manufacturing, leadership, and a strong focus on quality, reliability, and cost efficiency in both plant and office environments.