QA Manager

Piper Companies is looking for a Quality Assurance Manager to join a biotechnology company located in Elkridge, MD
.

• Manage daily operations and performance of the Quality Assurance and Document Control staff.
• Review, approve, and maintain quality documentation including deviations, CAPAs, change controls, investigations, procedures, protocols, and qualification records.
• Lead regulatory inspections, internal audits, supplier audits, and support audit readiness activities.
• Oversee document control processes, eDMS administration, training workflows, employee training records, and controlled document management.
• Manage product complaints, supplier complaints, adverse events, and risk assessments through investigation and closure.
• Perform QA oversight of manufacturing activities including room release, batch record review, critical process observation, and issue resolution.
• Ensure compliance with cGMP requirements, FDA regulations, company SOPs, and quality systems.
• Develop quality metrics/KPIs, support process improvements, and coordinate cross-functional quality initiatives.
• Review Quality Control testing data and support raw material and consumable release activities.
• Provide quality and eDMS training to internal and external users.

• Bachelor's degree in a scientific discipline or equivalent experience;
  Associate degree considered with additional relevant experience.
• 8+ years of experience in a GMP-regulated environment within the pharmaceutical, biotechnology, or related industry.
• Experience working in an FDA-regulated environment with direct involvement in regulatory inspections.
• Strong knowledge of cGMP requirements and US/EU regulatory standards.
• Previous leadership or supervisory experience managing QA personnel preferred.
• Experience with document control systems, preferably Master Control.
• Strong technical writing, organization, communication, and problem-solving skills.

• Rate Range: $115,000 - $135,000 annually
• Comprehensive Benefit Package:
  Cigna Medical/Dental/Vision, 401K, Sick Leave as Required by Law

This job is open for applications on August 19th, 2026. Applications will be accepted at least 30 days from the posting date.

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