QA Manager - 172434

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

Benefits offered by this job

Health benefits

401(k) plan

Sick leave

Job summary

Piper Companies is seeking a Quality Assurance Manager for a biotechnology company in Elkridge, MD. The role leads QA and document control, supports regulatory readiness, and ensures compliance with cGMP, FDA, and QMS.

You will manage audits, CAPAs, deviations, change controls, and batch release activities, while developing metrics and cross-functional quality initiatives.

Requirements include a science degree, 8+ years in GMP, MasterControl experience, strong writing and leadership skills.

Qualifications

• Bachelor’s degree in a scientific discipline or equivalent.
• 8+ years of GMP-regulated experience.
• Experience in FDA-regulated environments with regulatory inspections.
• Strong knowledge of cGMP, US/EU standards.
• Experience with document control systems (MasterControl preferred).
• Excellent written and verbal communication, organization, and problem-solving skills.

Responsibilities

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

Skills

Leadership experience

Technical writing

Communication skills

Problem-solving

Quality systems

GMP knowledge

Education

Bachelor's degree in science

Associate degree with relevant experience

Tools

MasterControl

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.

#LI-MU1

#LI-ONSITE