Quality Assurance Manager

Position Summary

The Quality Assurance Manager is responsible for establishing maintaining and continuously improving the quality systems that govern manufacturing operations at the facility ensuring full compliance with Good Manufacturing Practices (GMP) and applicable regulatory requirements (FDA APVMA and other relevant bodies). This role oversees batch release documentation control training audit management and complaint investigation while partnering closely with Production Quality Control Engineering R&D Maintenance and Logistics to uphold product quality and drive continuous improvement. The QA Manager also leads and develops the Quality Assurance team serving as the sites subject matter expert on quality standards and regulatory expectations.

Key Responsibilities

• Ensure production and support functions (materials management equipment calibrations validations etc.) conform to Good Manufacturing Practices.
• Perform batch release function for finished products.
• M aintain product quality by implementing a quality system that meets regulatory requirements and continuously improve quality processes and systems.
• Ensure that all procedures processes and facilities conform to quality system requirements.
• Manage the documentation system by writing (as needed) updating reviewing and approving all Standard Operating Procedures and Master Manufacturing Documents.
• Manage the training program by collaborating with Production Quality Control Maintenance Logistics and R&D to identify and develop needed training.
• Manage all internal and external audits (FDA APVMA and other relevant regulatory bodies) and ensure written responses are tracked and submitted as committed.
• Investigate evaluate and trend customer complaints for both regulatory and continuous improvement purposes.
• Approve product and process quality reports (production or quality control paperwork as needed; CAPAs change controls deviations complaints etc.).
• Prepare Quality Assurance reports (trend analyses) on a weekly monthly or annual basis as needed.
• Collaborate with Production and Quality Control to establish quality standards for production processes testing methods quality control procedures and specifications for raw materials in-process product and finished product.
• Provide Quality guidance and expertise for Production Engineering R&D Quality Control and other departments as needed.
• Manage the Quality Assurance teams workload and develop talent within the organization.
• Maintain and expand professional and technical knowledge by staying current with the latest Quality requirements.

Skills / Qualifications

• 35 years of experience in Quality in a GMP facility with previous leadership experience.
• Experience with or strong understanding of microbial fermentation processes.
• Bachelors degree in Chemistry Biology Biochemistry Engineering or a related scientific discipline.
• Strong interpersonal skills with both internal and external stakeholders.

Axiota is an Equal Opportunity Employer. We strive to foster a culture of respect and seek to empower each individual. All employment decisions are based on merit qualifications experience and abilities. This employer uses E-Verify.

Required Experience:

Manager