Quality Assurance Director

ZP Group; Elkridge (MD); On-site; USD 127,000 - 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 for an onsite role in Elkridge, MD, with occasional travel to nearby facilities. You will lead QA and document control, drive regulatory inspections readiness, and ensure cGMP compliance across US/EU standards.

Ideal candidates hold a science degree with 8+ years in GMP environments, FDA-regulated experience, and strong leadership in audits, CAPAs, and change control processes. MasterControl experience is preferred.

Qualifications

• Bachelor's degree in a scientific discipline is required.
• 8+ years of experience in GMP-regulated pharmaceutical/biotech environments.
• Experience in FDA-regulated settings.
• Experience leading audits and regulatory inspections.

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 in electronic systems.
• Investigate quality events, deviations, CAPAs, and change controls.
• Collaborate with Manufacturing, QC, Regulatory Affairs, and Operations.
• Drive continuous improvement and maintain inspection readiness.

Education

Bachelor's degree in a scientific discipline

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

Benefits Include:

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

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