Quality Assurance Director - 174207

Piper Companies; Elkridge (MD); On-site; USD 115,000 - 160,000; Full time

Benefits offered by this job

PTO

Paid Holidays

Medical

Dental

Vision

401K

Tuition Reimbursement

Paid Maternity Leave

Military Reserve Pay Offset

Job summary

Piper Companies is seeking a Quality Assurance Director to support a leading pharmaceutical/biotech manufacturer. This onsite role is in Elkridge, MD, with occasional travel to a nearby facility.

You will lead QA and Document Control, manage inspections, ensure cGMP compliance, and drive continuous improvement across QA, Regulatory Affairs, Manufacturing and Operations. Must have strong regulatory experience and people leadership.

Qualifications

• Experience in GMP-regulated pharmaceutical/biotech environments.
• Proven ability to lead regulatory inspections and audits.
• Strong knowledge of US/EU cGMP requirements.
• Experience with electronic document control systems; MasterControl preferred.
• 2+ years of supervisory or management experience overseeing QA teams.

Responsibilities

• Lead and manage QA and Document Control personnel to ensure GMP compliance.
• Oversee FDA, regulatory, customer, and internal inspections and audits.
• Ensure compliance with cGMP and US/EU regulatory requirements.
• Review, approve, and maintain quality documentation in electronic systems.
• Investigate quality events, deviations, CAPAs, and change controls.
• Collaborate cross-functionally with Manufacturing, QA, Regulatory Affairs, and Operations.
• Drive continuous improvement initiatives to strengthen quality systems and inspection readiness.

Skills

GMP compliance

Regulatory inspections

Leadership/people management

US/EU regulatory knowledge

Education

Bachelor's degree in a scientific discipline

Associate's degree with relevant experience

Tools

MasterControl

Job description

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