Director, QA & Quality Systems - Biomanufacturing

EPM Scientific; Stewartville (MN); On-site; USD 180,000 - 240,000; Full time

Job summary

EPM Scientific is assisting a publicly traded biotechnology organization in seeking a Director, Quality Assurance to provide strategic and operational leadership for quality systems in a highly regulated advanced biomanufacturing environment. This role partners cross-functionally to support development, manufacturing, and commercialization activities.

The incumbent will establish a culture of quality, inspection readiness, and continuous improvement, overseeing QA programs, deviations, CAPAs,

Qualifications

• Bachelor's degree in Life Sciences, Engineering, or related field.

Responsibilities

• Lead QA function with strategic direction, priorities, and performance objectives.
• Oversee and improve Quality Management System (QMS) processes and programs.
• Ensure compliance with FDA, GxP across manufacturing, laboratory, and operational functions.
• Provide quality oversight for deviations, investigations, CAPAs, change controls, complaints, supplier quality, and product quality reviews.
• Maintain robust systems for document control, data integrity, record management, and compliance reporting.
• Partner with Operations, Manufacturing, Facilities, Supply Chain, Regulatory Affairs, and R&D to support business objectives and product advancement.
• Lead internal, external, and regulatory inspections, audits, and agency interactions.
• Support validation programs, qualification activities, and quality review processes.
• Develop quality policies, procedures, and governance frameworks that drive right-first-time execution.
• Manage, mentor, and develop Quality team members while fostering a culture of accountability and continuous improvement.
• Oversee departmental planning, budgeting, staffing, and resource allocation.

Skills

Leadership

Cross-functional collaboration

Analytical skills

Communication

Decision-making

Education

Bachelor's degree in Life Sciences, Engineering, or related technical discipline

Advanced degree preferred

Tools

TrackWise

MasterControl

LIMS

SAP

Job description

EPM Scientific is assisting a publicly traded biotechnology organization in seeking a Director, Quality Assurance to provide strategic and operational leadership for quality systems in a highly regulated advanced biomanufacturing environment. This role partners cross-functionally to support development, manufacturing, and commercialization activities.

The incumbent will establish a culture of quality, inspection readiness, and continuous improvement, overseeing QA programs, deviations, CAPAs,