Quality Assurance Manager

Job Title: Quality Assurance Manager
Job Location: Santa Ana, CA (Onsite)
Job Type: Full-Time

Job Summary:

The Quality Assurance Manager will lead and manage the QA team within the sterile fill and drug manufacturing environment, ensuring daily operations meet both regulatory and company quality standards. This role oversees QA Supervisors and staff responsible for documentation review, investigations, deviations, change control, and CAPA management, ensuring all activities are executed in compliance with 21 CFR Parts 210 and 211. The Manager will maintain a state of constant inspection readiness and uphold the highest standards of product quality, data integrity, and regulatory compliance across all sterile manufacturing operations.

Key Responsibilities

• Lead and manage the Quality Assurance team, ensuring day-to-day operations align with regulatory and company standards.
• Oversee the QA Supervisor and staff responsible for documentation review, investigation, deviation, change control, and CAPA activities.
• Ensure compliance with 21 CFR Parts 210 and 211 and maintain a robust state of inspection readiness.
• Champion data integrity initiatives and ensure all quality records are accurate, complete, and contemporaneous.
• Support regulatory inspections, client audits, and internal audit programs.
• Collaborate with Manufacturing, QC, and Engineering to address quality issues and implement effective CAPAs.

Required Qualifications:

• Bachelor s degree in a scientific discipline (e.g., Chemistry, Biology, Pharmacy, or Engineering).
• 5 7 years of experience in Sterile drug manufacturing or aseptic operations within an FDA-regulated cGMP environment.
• Strong Experience in Sterile fill operations and quality systems management.
• In-depth knowledge of FDA cGMP regulations (21 CFR Parts 210/211), ISO standards, and data integrity principles.
• 2+ years in Leadership experience managing teams and supervising QA operations.