Quality Assurance Director

About the role

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

Requirements

• 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

Benefits

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

Pay

Salary: $135,000 - $170,000