Quality Assurance Manager - 174618

Zachary Piper Solutions; Elkridge (MD); On-site; USD 135,000 - 170,000; Full time

Benefits offered by this job

PTO

Paid Holidays

Medical, Dental, Vision

401(k)

Tuition Reimbursement

Paid Maternity Leave

Military Reserve Pay Offset

Job summary

Zachary Piper Solutions seeks a Quality Assurance Director to support a leading pharmaceutical and biotechnology manufacturing organization onsite in Elkridge, MD, with occasional travel to a nearby facility. You will lead QA and Document Control teams, oversee FDA inspections, ensure cGMP compliance, and drive continuous improvement across manufacturing, QC, Regulatory Affairs, and Operations.

Qualifications include a Bachelor's in a scientific field, 8+ years in GMP environments, and

Qualifications

• Bachelor's degree in a scientific discipline is required.
• 8+ years in GMP-regulated pharma/biotech environments.
• Experience in FDA-regulated settings.
• Experience leading audits and regulatory inspections.
• Strong knowledge of cGMP and US/EU standards.
• Electronic document control systems (MasterControl preferred).
• 2+ years of management or supervisory experience preferred.

Responsibilities

• Lead and manage QA and Document Control personnel.
• Oversee FDA, regulatory, customer, and internal inspections and audits.
• Ensure compliance with cGMP regulations and US/EU standards.
• Review, approve, and maintain quality documentation within electronic document control systems.
• Investigate quality events, deviations, CAPAs, and change controls.
• Collaborate with Manufacturing, QC, Regulatory Affairs, and Operations.
• Drive continuous improvement initiatives and maintain inspection readiness.

Skills

GMP knowledge

FDA inspections

Audits

Regulatory compliance

Education

Bachelor's degree in science

Tools

MasterControl

Job description

Zachary Piper Solutions is seeking a Quality Assurance Director to support a leading pharmaceutical and biotechnology manufacturing organization. This position is onsite in Elkridge, MD, with occasional travel to a nearby manufacturing facility.

Responsibilities

• Lead and manage Quality Assurance and Document Control personnel
• Oversee FDA, regulatory, customer, and internal inspections and audits
• Ensure compliance with cGMP regulations and US/EU regulatory requirements
• Review, approve, and maintain quality documentation within electronic document control systems
• Investigate quality events, deviations, CAPAs, and change controls
• Collaborate with Manufacturing, QC, Regulatory Affairs, and Operations
• Drive continuous improvement initiatives and maintain inspection readiness

Required Qualifications

• Bachelor's degree in a scientific discipline required
• 8+ years of experience in GMP-regulated pharmaceutical, biotechnology, or related environments
• Experience working in FDA-regulated settings
• Experience leading audits and regulatory inspections
• Strong knowledge of cGMP regulations and US/EU standards
• Electronic document control system experience (MasterControl preferred)
• 2+ years of management or supervisory experience preferred

Compensation & Benefits

Salary: $135,000 - $170,000

• PTO
• Paid Holidays
• Medical, Dental, Vision
• 401(k)
• Tuition Reimbursement
• Paid Maternity Leave
• Military Reserve Pay Offset