Quality Assurance Director

Job overview

The Quality Assurance Director works onsite in Pipersville, PA. Compensation is not specified. Lampire Biological Labs provides biological reagents to pharmaceutical, diagnostic, and biotechnology industries. The director leads quality compliance and improvement across the company’s quality management system and six Pennsylvania facilities. The role oversees quality and document-control staff, audits, training, corrective actions, supplier oversight, and production controls to support compliant operations.

What you'll do

• Plan, implement, and monitor the company-wide quality management system
• ensure compliance with ISO, FDA, EU, and USDA requirements
• supervise QA and Document Control staff
• establish and monitor quality policies and objectives
• prepare for and respond to client, regulatory, and internal audits
• manage training and management reviews
• oversee investigations, corrections, and CAPAs
• manage supplier ranking, audits, and surveillance
• review controlled documents, specifications, change controls, and validations
• oversee production and process controls, records, traceability, labeling, packaging, and shipping
• support finished-goods release and nonconforming-material disposition.

What we're looking for

Skills & competencies

quality assurance director

quality management system

regulatory compliance

iso 9001

iso 13485

21 cfr 820

audits and inspections

capa

supplier management

pipersville pa

lampire biological labs

biotechnology

document control

Work arrangement

• Weekend coverage required

Benefits & perks

• The posting describes competitive compensation, comprehensive health benefits, retirement benefits, and recognition for operational initiative.

Why this role

The posting covers quality oversight across six Pennsylvania facilities and calls for experience with ISO 9001, ISO 13485, and/or 21 CFR 820; a scientific bachelor’s degree is preferred.

About the employer

Lampire Biological Laboratories, Inc. is hiring for this role. Industry: Research and Development in Biotechnology (except Nanobiotechnology). Sector: 54.