Quality Assurance Director

Job Summary

Piper 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.

• 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.

• 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;
  Master Control preferred.
• 2+ years of supervisory or management experience overseeing QA teams preferred.

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