Manager, Quality Assurance

Title: Manager, Quality Assurance

Location: Springfield, MO (On-site)

Summary:

The Quality Assurance Manager is responsible for oversight of conditions and activities in API manufacturing areas to ensure continual compliance with cGMP standards. This position requires expertise in all aspects of API manufacturing, hands-on capability, strong leadership skills, and the ability to collaborate in a cross-functional environment. The individual will work closely with all departments in the manufacturing setting and report key quality metrics to site management on a regular basis.

Responsibilities:

• Assist the Site Quality Head with developing, implementing, and maintaining a robust quality assurance program
• Develop and/or review standards, policies, and procedures for all functions and departments involved in production and testing of materials
• Oversee and assist with site training and auditing programs, changes, investigations, validations, approval of specifications and methods, review of data and manufacturing records, and vendor qualifications
• Ensure immediate corrective action when non-compliance or undesired behavior by personnel is observed
• Make recommendations regarding facilities, equipment, personnel, procedures, and systems to strengthen the quality function
• Ensure data integrity principles are understood and consistently implemented across the site
• Lead process improvement initiatives, collaborating with Operations, Quality, and Training leadership to enhance quality processes, provide coaching, and implement updated procedures
• Coordinate corrective action training based on feedback from observations and evaluations
• Assist Site Quality Head during regulatory inspections, including implementing inspection-readiness programs and ensuring timely completion of CAPAs
• Partner with site stakeholders to maintain operational excellence, site-wide quality compliance, and a strong quality culture while supporting business objectives
• Lead and support site-wide cGMP training activities
• Communicate effectively with internal and external stakeholders to ensure alignment with organizational goals
• Ensure daily inspections are carried out

Qualifications:

• Bachelor's Degree in Microbiology, Chemistry, or related field
• Minimum 5 years of GMP experience in an FDA-regulated pharmaceutical environment, including 2 years of supervisory experience OR
• Master's Degree in Microbiology, Chemistry, or related field with minimum 3 years of GMP experience in an FDA-regulated pharmaceutical environment, including 2 years of supervisory experience

Other Requirements:

• Must pass a background check
• Must pass a drug screen
• May be required to pass Occupational Health Screening

Preferred:

• Advanced degree in a related field
• Prior experience in a Contract Manufacturing Organization (CMO)