Quality Assurance Director

Job AttributesJob Id:

174207

Job Category:

Job Location:

Elkridge, MarylandSecurity Clearance:

No ClearanceBusiness Unit:

Piper CompaniesDivision:

Piper Clinical SolutionsPosition Owner:

Kamille PurcellQuality Assurance Associate DirectorJob SummaryPiper Companies 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 as needed.

Responsibilities for the Quality Assurance Director include

• Lead and manage Quality Assurance and Document Control personnel to ensure compliance with GMP standards.
• Oversee FDA, regulatory, customer, and internal inspections and audits.
• Ensure compliance with cGMP regulations and applicable US and EU regulatory requirements.
• Review, approve, and maintain quality documentation within electronic document control systems.
• Investigate quality events, deviations, CAPAs, and change controls.
• Collaborate cross-functionally with Manufacturing, Quality Control, Regulatory Affairs, and Operations teams.
• Drive continuous improvement initiatives to strengthen quality systems and inspection readiness.
  Required Qualifications for the Quality Assurance Director include
  
• Bachelor's degree in a scientific discipline required; Associate's degree considered with additional relevant experience.
  
• 8+ years of experience in a GMP-regulated pharmaceutical, biotechnology, or related environment.
  
• Experience working in an FDA-regulated environment.
  
• Proven experience leading and managing regulatory inspections and audits.
  
• Strong knowledge of cGMP requirements and US/EU regulatory standards.
  
• Experience with electronic document control systems; MasterControl preferred.
  
• 2+ years of supervisory or management experience overseeing QA teams preferred.

Compensation

Salary Range:

$115,000-$160,000

Full Benefits Package:

PTO, Paid Holidays, Medical, Dental, Vision, 401K, Tuition Reimbursement, Paid Maternity Leave, Military Reserve Pay Offset