Senior QA & Compliance Manager - Biotech

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 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.