Quality Assurance Manager - 174618

Piper Companies; 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 is seeking a Quality Assurance Director to support a leading pharmaceutical and biotechnology manufacturing organization. This on-site role is in Elkridge, MD, with occasional travel to nearby facilities.

Key responsibilities include leading QA and Document Control teams, overseeing FDA inspections, and ensuring cGMP compliance across US/EU standards. Strong leadership and audit experience are required, with MasterControl or similar eQMS expertise preferred.

Qualifications

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

Audit leadership

Regulatory inspections

Quality systems

Management experience

Education

Bachelor's degree in a scientific discipline

Tools

MasterControl

eQMS

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

#AK1

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cGMP

CAPA

Change Control

Deviations

Audits

Regulatory Inspections

FDA Audits

MasterControl

eQMS

Document Control

Quality Systems

Inspection Readiness