Onsite Pharma Quality Assurance Director | Elkridge

Zachary Piper Solutions; Elkridge, Northern (MD, KY); Hybrid; 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 in Elkridge, MD is seeking a Quality Assurance Director to lead QA and document control, oversee inspections, ensure cGMP compliance, and drive continuous improvement within a pharmaceutical/biotech manufacturing setting.

The role is onsite in Elkridge with occasional travel to a nearby facility; requires 8+ years in GMP environments and leadership experience. Salary range is $135,000–$170,000 with comprehensive benefits.

Qualifications

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

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

Skills

GMP experience

FDA-regulated experience

Audits & inspections

cGMP knowledge

Management experience

Education

Bachelor's degree in a scientific discipline

Tools

MasterControl

Job description

Zachary Piper Solutions in Elkridge, MD is seeking a Quality Assurance Director to lead QA and document control, oversee inspections, ensure cGMP compliance, and drive continuous improvement within a pharmaceutical/biotech manufacturing setting.

The role is onsite in Elkridge with occasional travel to a nearby facility; requires 8+ years in GMP environments and leadership experience. Salary range is $135,000–$170,000 with comprehensive benefits.