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 Quality Assurance Director, Director of Quality Assurance, QA Director, Director of QA, Quality Director, Director of Quality, Associate Director Quality Assurance, Associate Director QA, Senior Quality Assurance Manager, Senior QA Manager, Quality Assurance Manager, QA Manager, Quality Manager, Quality Operations Director, Director of Quality Operations, Quality Operations Manager, Senior Quality Operations Manager, Quality Compliance Director, Quality Compliance Manager, Quality Systems Director, Quality Systems Manager, GMP Quality Manager, cGMP Quality Manager, Pharmaceutical Quality Manager, Biopharmaceutical Quality Manager, Quality Assurance Lead, QA Lead, Quality Operations Lead, QA Supervisor, Quality Assurance Supervisor, GMP Quality Assurance, cGMP Quality Assurance, Pharmaceutical Quality Assurance, Biopharmaceutical Quality Assurance, Biotechnology Quality Assurance, Biologics Quality Assurance, Manufacturing Quality Assurance, Operational Quality Assurance, QA Operations, QA on the Floor, On the Floor QA, Floor QA, Manufacturing Quality, Pharmaceutical Manufacturing, Biopharmaceutical Manufacturing, Biotechnology Manufacturing, Biologics Manufacturing, Drug Product Manufacturing, Drug Substance Manufacturing, Aseptic Manufacturing, Sterile Manufacturing, Cell Therapy Manufacturing, Gene Therapy Manufacturing, Cell and Gene Therapy, Pharmaceutical, Pharma, Biotechnology, Biotech, Biopharma, Biopharmaceutical, Biologics, Life Sciences, CMO, CDMO, Contract Manufacturing Organization, Contract Development and Manufacturing Organization, GMP, cGMP, GxP, FDA, FDA Compliance, FDA Regulations, FDA Regulated Manufacturing, FDA Inspection, FDA Inspections, FDA Audit, FDA Audits, FDA Inspection Lead, FDA Inspection Management, FDA Inspection Readiness, FDA Regulatory Inspection, Regulatory Inspection, Regulatory Inspections, Regulatory Audit, Health Authority Inspection, Health Authority Inspections, Inspection Management, Inspection Readiness, Audit Readiness, Audit Management, Audit Lead, Internal Audits, External Audits, Client Audits, Customer Audits, Regulatory Compliance, 21 CFR 210, 21 CFR 211, EU GMP, EudraLex, ICH, ICH

Q9, ICH Q10, CAPA, CAPA

Management, Corrective and Preventive Action, Deviations, Deviation Management, Deviation Investigation, Quality Investigations, Manufacturing Investigations, Root Cause Analysis, RCA, Change Control, Quality Events, Nonconformance Management, OOS, Out of Specification, OOT, Batch Record Review, Batch Records, Batch Disposition, Batch Release, Product Release, Lot Release, Raw Material Release, Line Clearance, Room Release, Area Clearance, Manufacturing Oversight, Quality Oversight, GMP Oversight, Quality Management System, Quality Management Systems, QMS, eQMS, Document Control, Electronic Document Management System, EDMS, MasterControl, TrackWise, Veeva Vault

QMS, SOP

Management, Quality Risk Management, QRM, Data Integrity, ALCOA+, Continuous Improvement, Operational Excellence, PAI, Pre Approval Inspection, Commercial Readiness, Process Validation, Equipment Qualification, Supplier Quality, CMO Oversight, CDMO Oversight, Quality Agreements, Quality Leadership, QA Leadership, People Management, Quality Team Management, GMP Training, Manufacturing Operations, Quality Control, QC, Regulatory Affairs, Elkridge, Baltimore, Rockville, Gaithersburg, Frederick, Maryland