Quality Assurance Manager

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

Benefits offered by this job

PTO

Paid Holidays

Medical Insurance

Dental Insurance

Vision Insurance

401K

Tuition Reimbursement

Paid Maternity Leave

Military Reserve Pay Offset

Job summary

Piper Companies in Elkridge, MD is seeking a QA Manager to support a growing pharmaceutical manufacturing organization. This onsite role will lead QA operations, ensuring cGMP compliance and timely product releases.

You'll oversee deviations, CAPAs, change controls and audits, mentor QA staff, manage the eDMS (MasterControl), and partner with cross-functional teams to drive continuous quality improvements in a fast-paced environment.

Qualifications

• Bachelor's degree in a scientific discipline or equivalent.
• 8+ years of experience within a GMP-regulated pharmaceutical/biotechnology/life sciences environment.
• Experience in an FDA-regulated environment and regulatory inspections.
• Knowledge of US and EU regulatory requirements.

Responsibilities

• Oversee daily QA operations, mentoring staff and performance management.
• Ensure compliance with cGMP regulations, quality systems, SOPs, and regulatory requirements.
• Review and approve deviations, CAPAs, change controls, investigations, and batch records.
• Oversee document control and eDMS administration (MasterControl).
• Conduct risk assessments, trend analysis, and root cause investigations for continuous improvement.
• Partner with cross-functional teams to provide QA oversight and support product releases.
• Lead internal and supplier audits and support regulatory inspections and responses.
• Develop and report quality metrics and deliver QA training.

Skills

Leadership

Regulatory knowledge

Quality systems

Communication

Microsoft Office

Education

Bachelor's degree in a scientific discipline

Tools

MasterControl

Job description

QA Manager

Department: Quality Assurance

Job Summary

Piper Companies is seeking a QA Manager to support a growing pharmaceutical manufacturing organization. This position is onsite at the client's manufacturing facility in Elkridge, MD.

Responsibilities for the QA Manager Include:

• Lead and manage daily Quality Assurance operations, providing oversight, mentorship, and performance management for QA staff.
• Ensure compliance with cGMP regulations, quality systems, SOPs, and regulatory requirements across manufacturing and quality operations.
• Review and approve quality documentation, including deviations, CAPAs, change controls, investigations, complaints, qualification activities, and batch records.
• Oversee document control processes and administration of the electronic Document Management System (eDMS), ensuring document accuracy, training compliance, and record retention.
• Conduct and support risk assessments, trend analysis, root cause investigations, and continuous improvement initiatives to enhance quality performance.
• Partner with cross-functional teams to provide quality oversight, resolve compliance issues, and support manufacturing operations and product release activities.
• Lead internal and supplier audits while supporting regulatory inspections, audit readiness efforts, and responses to regulatory agencies.
• Develop, track, and report quality metrics and KPIs while delivering quality-related training and promoting a culture of continuous improvement.

Required Qualifications for the QA Manager Include:

Education & Experience

• Bachelor's degree in a scientific discipline or equivalent combination of education and experience.
• Minimum of 8 years of experience within a GMP-regulated pharmaceutical, biotechnology, or life sciences environment.
• Experience working in an FDA-regulated environment required.
• Experience supporting and participating in regulatory inspections required.
• Demonstrated knowledge of US and EU regulatory requirements.

Technical Skills & Abilities

• Strong knowledge of cGMP regulations and quality systems.
• Experience with electronic document management systems, preferably MasterControl.
• Proficiency in Microsoft Office Suite, including Word, Excel, Outlook, PowerPoint, Access, and Adobe Acrobat.
• Strong technical writing, editing, and documentation review skills.
• Experience conducting investigations, risk assessments, and root cause analyses.
• Excellent organizational, presentation, and facilitation skills.
• Strong leadership and personnel management experience.
• Excellent verbal and written communication abilities.
• Ability to lead cross-functional teams and drive quality-focused initiatives.
• Ability to work effectively in a dynamic, fast-paced manufacturing environment.
• Ability to gown and work within cleanroom environments, including ISO 5 areas.

Compensation for the QA Manager Includes:

• Salary Range: $115,000 - $135,000
• Full Benefits Package: PTO, Paid Holidays, Medical, Dental, Vision, 401K, Tuition Reimbursement, Paid Maternity Leave, Military Reserve Pay Offset

This Job opens for applications on August 10, 2026. Applications for this job will be accepted for at least 30 days from the posting date.

#LI-KP1 #LI-ONSITE

Keywords

Quality Assurance Manager, QA Manager, Pharmaceutical Manufacturing, Biotechnology, GMP, cGMP, FDA, Regulatory Compliance, Quality Systems, CAPA, Deviations, Change Control, Risk Assessment, Root Cause Analysis, Quality Investigations, Batch Record Review, Document Control, eDMS, MasterControl, Internal Audits, Supplier Audits, Regulatory Inspections, Training Management, Quality Metrics, OOS Investigations, Cleanroom Operations, ISO 5, Manufacturing Quality, Quality Operations, Life Sciences.