Senior Microbiology Quality Leader

Baxter

Marion (NC)

In loco

USD 120.000 - 180.000

Tempo pieno

5 giorni fa

Candidati tra i primi

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Vantaggi offerti da questo lavoro

Health insurance

Dental coverage

401(k) with company match

Employee stock purchase plan (ESPP)

Paid time off 20–35 days

Descrizione del lavoro

Baxter is seeking a Senior Quality Manager in the United States to lead microbiology testing teams and ensure GMP/GLP compliance across manufacturing. You will drive cross-functional collaboration, audits, and continuous improvement to safeguard product quality and patient safety.

The role requires extensive experience in aseptic manufacturing, strong leadership, and deep knowledge of regulatory requirements (USP, FDA, ISO).

Competenze

Bachelor's degree in Science (Biology or Microbiology) or equivalent.
10+ years in Quality, Manufacturing, Engineering or related field.
7+ years in a cGMP-related industry.
5+ years leadership/supervision in aseptic or sterile manufacturing.
Knowledge of microbiology testing techniques (bioburden, endotoxin, particulates, identification).
Familiarity with USP, FDA, ISO standards.
Demonstrated leadership, communication and interpersonal skills.
Strong analytical and problem-solving skills.

Mansioni

Develop a team of supervisors and/or department leads involved in microbiology testing.
Supervise product testing procedures (bioburden, endotoxin, particulates, identification).
Ensure GMP and GLP compliance and other regulations.
Coordinate with cross-functional teams on testing requirements and timelines.
Collaborate with QA to resolve deviations, investigations and CAPAs.
Participate in audits, including FDA interactions.
Stay informed on industry trends and regulatory changes.
Lead KPIs and continuous improvement projects.