Onsite QA Manager: GMP/FDA Leader in Pharma

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

Benefits offered by this job

Comprehensive benefits package

Job summary

Piper Companies is seeking a Quality Assurance Manager in Elkridge, Maryland, to lead QA within a GMP environment for a growing pharmaceutical company. The role emphasizes leadership, regulatory compliance, and document control excellence.

The position requires extensive experience in cGMP, US/EU regulatory knowledge, and a scientific Bachelor's degree. A comprehensive benefits package and on-site work are provided.

Qualifications

• Minimum 8+ years in FDA/GMP manufacturing environments.
• Hands-on leadership experience in pharmaceutical QA.
• In-depth knowledge of cGMP and US/EU regulations.
• Bachelor's or higher degree in a scientific field.

Responsibilities

• Manage a team of QA professionals in a GDA/GMP pharmaceutical environment.
• Follow SOPs to support document approvals, training workflows, and archiving.
• Serve as eDMS administrator and coordinate change control documentation.
• Resolve document control issues with originators and stakeholders.
• Organize and maintain controlled document files for retrievability.
• Ensure compliance with FDA and international regulatory guidelines.
• Maintain training records, master files, and authorized signatures.
• Familiarize operations with site processes and cGMP Health Authority regulations.
• Review and approve qualification activities, deviations, complaints, investigations, and procedures.

Skills

Leadership

Regulatory knowledge

GMP experience

Quality Assurance

Education

Bachelor's degree in Scientific field

Tools

eDMS

Job description

Piper Companies is seeking a Quality Assurance Manager in Elkridge, Maryland, to lead QA within a GMP environment for a growing pharmaceutical company. The role emphasizes leadership, regulatory compliance, and document control excellence.

The position requires extensive experience in cGMP, US/EU regulatory knowledge, and a scientific Bachelor's degree. A comprehensive benefits package and on-site work are provided.