Biotech QA Manager: GMP, Audits & Compliance Leader

Zachary Piper Solutions; Elkridge (MD); On-site; USD 115,000 - 135,000; Full time

Benefits offered by this job

Comprehensive Benefits

Job summary

Piper Companies is seeking a Quality Assurance Manager to join a biotechnology company in Elkridge, MD. You will lead the Quality Assurance and Document Control teams, review quality documentation, and drive audit readiness while ensuring cGMP compliance across manufacturing activities.

Ideal candidates have 8+ years in a GMP-regulated environment, direct FDA inspection experience, and strong leadership. MasterControl experience is preferred.

Qualifications

• 8+ years in a GMP-regulated environment (pharma/ biotech).
• Experience in FDA-regulated environments with regulatory inspections.
• Strong knowledge of cGMP and US/EU regulatory standards.
• Experience leading QA personnel.

Responsibilities

• Manage daily operations and performance of the QA 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.

Skills

Regulatory inspections

Leadership

Technical writing

Cross-functional collaboration

Quality systems

Education

Bachelor’s degree in science or related field

Associate degree with relevant experience

Tools

MasterControl

Job description

Piper Companies is seeking a Quality Assurance Manager to join a biotechnology company in Elkridge, MD. You will lead the Quality Assurance and Document Control teams, review quality documentation, and drive audit readiness while ensuring cGMP compliance across manufacturing activities.

Ideal candidates have 8+ years in a GMP-regulated environment, direct FDA inspection experience, and strong leadership. MasterControl experience is preferred.