Onsite Quality Manager — FDA/cGMP Compliance (Hoover, AL)

Actalent; Hoover (AL); On-site; USD 110,000 - 140,000; Full time

Benefits offered by this job

Competitive benefits

Onsite work

Job summary

Actalent in Hoover, AL, is seeking a Quality Manager to lead QA/QC programs in a 503B outsourcing facility. You will ensure compliance with FDA, cGMP, USP, and DEA regulations, oversee audits, investigations, and continuous improvement initiatives.

The role requires hands-on management of sterile compounding quality, environmental monitoring, and documentation across production and testing. You will collaborate with department managers to drive training, validations, and rapid corrective actions.

Qualifications

• 3+ years in quality management or QA.
• Strong knowledge of FDA 21 CFR 210/211.
• Experience with aseptic compounding and sterile operations.
• Excellent documentation and data integrity skills.
• Experience with audits and regulatory inspections.

Responsibilities

• Lead audits and supplier audits.
• Oversee QA/QC for compounding and quality personnel.
• Manage investigations, CAPAs, and change controls.
• Review batch records, certificates of analysis, and release specs.
• Coordinate recalls of medications when applicable.
• Prepare and maintain validation of equipment and processes.
• Ensure environmental monitoring and sterility testing.
• Collaborate with managers on training and validations.
• Support inspections by FDA and accreditation bodies.
• Drive continuous improvement in quality and regulatory readiness.

Skills

QA/QC management

FDA regulations

cGMP knowledge

CAPA management

Audits & inspections

Data-driven decisions

Communication skills

Education

Bachelor's degree in QA/Science

Tools

MasterControl QMS

Job description

Actalent in Hoover, AL, is seeking a Quality Manager to lead QA/QC programs in a 503B outsourcing facility. You will ensure compliance with FDA, cGMP, USP, and DEA regulations, oversee audits, investigations, and continuous improvement initiatives.

The role requires hands-on management of sterile compounding quality, environmental monitoring, and documentation across production and testing. You will collaborate with department managers to drive training, validations, and rapid corrective actions.