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 & BenefitsSalary: $135,000 - $170,000
Benefits Include:- PTO
- Paid Holidays
- Medical, Dental, Vision
- 401(k)
- Tuition Reimbursement
- Paid Maternity Leave
- Military Reserve Pay Offset
#AK1
Quality Assurance Manager
QA Manager
Quality Manager
GMP Quality Manager
Quality Systems Manager
Senior Quality Manager
Pharmaceutical Quality Assurance
Biotech Quality Assurance
Quality Compliance Manager
GMP Manager
cGMP Manager
FDA Compliance Manager
Document Control Manager
Quality Operations Manager
Validation Manager
Quality Assurance Lead
Quality Systems Lead
QA Lead
Pharmaceutical Manufacturing
Biotechnology Manufacturing
Life Sciences
FDA Regulated Environment
GMP
cGMP
CAPA
Change Control
Deviations
Audits
Regulatory Inspections
FDA Audits
MasterControl
eQMS
Document Control
Quality Systems
Inspection Readiness
