Onsite QA Manager - GMP & Regulatory Excellence

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

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.