Quality Assurance Manager

We are seeking an experienced QA Manager to lead and maintain our Quality Management System (QMS) in a cGMP-regulated pharmaceutical environment. This role is responsible for overseeing core quality systems including deviations, CAPA, change control, document control, and training, ensuring compliance with FDA regulations and driving continuous improvement across the organization.

Key Responsibilities

• Manage the site Quality Management System (QMS), including deviations, CAPA, change control, document control, and training systems
• Ensure compliance with FDA regulations including 21 CFR Part 210, 21 CFR Part 211, and 21 CFR Part 11
• Lead investigations, approve quality events, and ensure timely closure of CAPAs and deviations
• Oversee document control processes, including SOP creation, revision, and approval
• Manage and improve quality metrics, trending, and reporting to senior leadership
• Support and lead FDA inspections and regulatory audits; prepare and review responses to observations
• Ensure effective training programs are in place and maintained for GMP compliance
• Partner cross-functionally with Manufacturing, QC, and Regulatory teams to resolve quality issues
• Drive continuous improvement initiatives to strengthen quality systems and compliance

Qualifications

• Bachelor’s degree in a scientific discipline (Chemistry, Biology, Pharmacy, or related)
• 7 years of experience in pharmaceutical or FDA-regulated industry
• 3 years of people management experience (direct reports required)
• Strong experience owning and managing QMS systems (deviations, CAPA, change control, etc.)
• Experience leading or supporting FDA inspections and audits
• Working knowledge of QMS platforms such as MasterControl, TrackWise, or similar
• Strong communication, leadership, and organizational skills
• Preferred
• Experience implementing or improving electronic QMS systems
• Proven track record of driving quality improvements and audit readiness
• CDMO experience
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