GMP Quality Assurance Lead | Compliance & Audit Expert

Axiota Animal Health; Wamego (KS); On-site; USD 110,000 - 150,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

Life insurance

401(k) with match

FSA

HSA

EAP

Paid time off

9 paid holidays

Job summary

Axiota Animal Health is seeking a Quality Assurance Manager to establish, maintain, and continuously improve GMP-compliant quality systems for the manufacturing facility. You will lead batch release, documentation control, audits, training, and investigations while partnering with Production, QC, Engineering, R&D, Maintenance, and Logistics.

You will manage the QA team, develop talent, stay current with regulatory expectations, and drive continuous improvement across processes and materials.

Qualifications

• 3–5 years of quality experience in a GMP facility.
• Experience with microbial fermentation processes.
• Bachelor’s degree in Chemistry, Biology, Biochemistry, Engineering, or related field.
• Strong interpersonal skills with internal and external stakeholders.

Responsibilities

• Oversee GMP compliance for manufacturing operations.
• Perform batch release for finished products.
• Maintain quality systems and drive continuous improvement.
• Manage documentation and SOPs.
• Lead audits (FDA, APVMA, others) and responses.
• Lead QA team development and training.
• Collaborate with Production, QC, R&D, and others.

Skills

Leadership experience

GMP knowledge

Interpersonal skills

Education

Bachelor's degree in Chemistry, Biology, Biochemistry, Engineering, or related field

Job description

Axiota Animal Health is seeking a Quality Assurance Manager to establish, maintain, and continuously improve GMP-compliant quality systems for the manufacturing facility. You will lead batch release, documentation control, audits, training, and investigations while partnering with Production, QC, Engineering, R&D, Maintenance, and Logistics.

You will manage the QA team, develop talent, stay current with regulatory expectations, and drive continuous improvement across processes and materials.