Quality Assurance Associate 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.
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
