QA Manager - 172434

ZP Group; Elkridge (MD); On-site; USD 115,000 - 135,000; Full time

Benefits offered by this job

Medical/Dental/Vision insurance

401K

Sick Leave as required by law

Job summary

Piper Companies seeks a Quality Assurance Manager for a biotechnology operation in Elkridge, MD. You will lead QA and Document Control, ensuring cGMP compliance and readiness for FDA inspections, while guiding QA staff and cross-functional initiatives.

You will oversee deviations, CAPAs, change controls, investigations, and supplier quality issues, driving data integrity and risk management in a fast-paced manufacturing environment.

Qualifications

• 8+ years of GMP-regulated experience.
• Experience in an FDA-regulated environment with regulatory inspections.
• Strong knowledge of cGMP requirements and US/EU standards.
• Previous leadership or supervisory experience in QA.
• Experience with document control systems, preferably MasterControl.
• Strong technical writing, organization and communication skills.

Responsibilities

• Manage daily operations of QA and Document Control staff.
• Review, approve and maintain quality documentation incl deviations, CAPAs, change controls and investigations.
• Lead regulatory inspections and internal/supplier audits; support audit readiness.
• Oversee document control processes, eDMS administration and training records.
• Manage product and supplier complaints, adverse events and risk assessments.
• QA oversight of manufacturing activities including batch review and release.
• Ensure compliance with cGMP and FDA regulations; uphold quality systems.
• Develop quality metrics/KPIs and drive process improvements.
• Review QC testing data and support material release activities.
• Provide quality and eDMS training to internal and external users.

Skills

QA leadership

Regulatory inspections

Technical writing

Process improvement

Cross-functional collaboration

CAPA/Investigations

Document control systems

MasterControl

Education

Bachelor’s degree in a scientific discipline

Associate degree with relevant experience

Tools

MasterControl

eDMS

Quality systems

Job description

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

Responsibilities of the Quality Assurance Manager include:

• 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.

Qualifications for the Quality Assurance Manager include:

• 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 MasterControl.
• Strong technical writing, organization, communication, and problem-solving skills.

Compensation for Quality Assurance Manager includes:

• 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.

Keywords: Quality Assurance Manager, QA Manager, GMP, cGMP, FDA, EMA, ICH, Regulatory Compliance, Regulatory Inspections, FDA Inspections, Audit Readiness, Quality Systems, Quality Management System (QMS), CAPA, Corrective and Preventive Actions, Deviations, Non-Conformance Investigations, Root Cause Analysis, Change Control, Quality Risk Management, Risk Assessments, Risk Mitigation, Product Complaints, Supplier Complaints, Adverse Events, Out of Specification (OOS), Out of Trend (OOT), Quality Events, Batch Record Review, Batch Release, Material Release, Raw Material Release, Manufacturing Oversight, QA Floor Support, Quality Oversight, Process Improvement, Continuous Improvement, Technical Review, Document Control, Electronic Document Management System (eDMS), MasterControl, Controlled Documents, SOP Management, Training Management, Records Management, Data Integrity, ALCOA+, Good Documentation Practices (GDP), Validation Documentation, Qualification Documentation, Supplier Quality, Vendor Management, Internal Audits, Supplier Audits, Quality Metrics, KPI Development, Inspection Readiness, Regulatory Responses, Quality Compliance, Pharmaceutical Manufacturing, Biotechnology Manufacturing, Aseptic Processing, Cleanroom Operations, ISO 5, Investigation Management, Cross-Functional Leadership, Quality Operations, Quality Review, Technical Writing, Process Controls, Quality Governance, Pharmaceutical Quality Systems (PQS), cGMP Documentation, Health Authority Regulations, Manufacturing Support, Compliance Management, Quality Assurance Leadership.

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