Director of QA

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

Director, Quality Assurance - Advanced Biomanufacturing & Regulated Operations

Our client is a publicly traded biotechnology organization focused on developing innovative therapies for patients with serious and life-threatening diseases. In addition to advancing treatments for rare conditions, the company is pioneering next-generation manufacturing technologies designed to address critical unmet medical needs through highly specialized biological and regenerative medicine platforms.

Position Overview

Our client is seeking a Director, Quality Assurance to provide strategic and operational leadership for quality systems supporting a highly regulated, cutting-edge manufacturing environment. This individual will oversee Quality Assurance programs, ensure compliance with applicable regulatory requirements, and partner cross-functionally to support product development, manufacturing, and commercialization activities.

This is a highly visible leadership role responsible for building and maintaining a culture of quality, inspection readiness, operational excellence, and continuous improvement.

Key Responsibilities

• Lead the Quality Assurance function, establishing strategic direction, priorities, and performance objectives.
• Oversee and continuously improve Quality Management System (QMS) processes and programs.
• Ensure compliance with applicable FDA, GxP, and other regulatory requirements 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.

Qualifications

Required

• Bachelor's degree in Life Sciences, Engineering, or a related technical discipline; advanced degree preferred.
• 15+ years of experience within FDA-regulated GxP environments.
• Significant leadership experience managing Quality Assurance teams and quality systems.
• Demonstrated experience leading regulatory inspections and responding to regulatory agencies.
• Strong expertise in Quality Systems, compliance, risk management, investigations, CAPAs, change control, and audit management.
• Proven ability to influence cross-functional stakeholders and drive quality culture initiatives.
• Excellent analytical, problem-solving, communication, and decision-making skills.
• Proficiency with Microsoft Office applications.
• Ability to work onsite within a regulated manufacturing environment.

Preferred

• Experience supporting advanced biologics, cell therapy, tissue processing, regenerative medicine, transplant-related technologies, or other complex biological manufacturing operations.
• Experience with electronic quality management and document management systems such as TrackWise and MasterControl.
• Familiarity with Laboratory Information Management Systems (LIMS).
• Experience working with enterprise resource planning systems such as SAP.

Why Consider This Opportunity?

• Leadership role with significant visibility and strategic influence.
• Opportunity to shape quality systems supporting groundbreaking healthcare innovations.
• Direct partnership with executive leadership and cross-functional teams.
• Ability to contribute to transformative technologies aimed at improving outcomes for patients facing serious diseases.
• Competitive compensation, comprehensive benefits, and long-term career growth potential.