Manager, Quality Assurance

About the role

Axogen’s mission is to restore health and improve quality of life by making restoration of peripheral nerve function an expected standard of care. The Manager, Quality Assurance will lead QA operations at Axogen facilities, ensuring compliance with cGMP, cGDP, and international standards for tissue, biologic, and medical device products while fostering a culture of continuous improvement.

Responsibilities

• Establish, implement, and maintain Axogen’s Quality Management Systems (QMS) aligned with cGMP, cGDP, QSR, ISO 13485, MDD, AATB, and other applicable standards.
• Manage QA operations at Processing Centers (DPC/APC) or the Burleson Distribution Center (BDC), ensuring compliance with domestic and international quality standards.
• Recruit, develop, and lead the quality assurance team, fostering a positive workplace culture and high performance.
• Provide strategic leadership, coaching, and performance development while ensuring alignment with company objectives and regulatory compliance.
• Act as the subject matter expert for tissue, medical device, and biologic regulations; represent Axogen during external audits and inspections.
• Collaborate with Operations, Finance, and Material Handling teams to support GMP activities and meet product demand and regulatory requirements.
• Lead quality planning, verification/validation, continuous improvement, and risk assessment activities.
• Investigate and reduce non-conformances; optimize inspection processes; oversee qualification and validation activities.
• Train staff on quality policies and procedures; facilitate communication regarding changes in facilities, processes, and materials.
• Prepare quality metrics, reports, and presentations for stakeholders.
• Leverage analytical skills and best practices to identify opportunities for efficiency, cost reduction, and workflow improvements.

Specific Duties at APC (Cleanroom Processing and Laboratory Operations)

• Oversight of Avance Starting Material, Drug Substance, and Drug Product processing, including room release, environmental monitoring, sample management, gowning, process validation, and quarterly dose audits.
• Serve as the QA subject matter expert for computer systems (e.g., Tulip, LIMS, particle monitoring systems).

Specific Duties at APC (Drug Product, Facility, and Technical Operations)

• Oversight of qualification, maintenance, and calibration activities for equipment, facilities, and utilities; labeling quality review and disposition of drug product and chain of custody.
• Serve as the QA subject matter expert for computer systems (e.g., maintenance management, cleaning & sterilization, building monitoring, security access control).

Requirements

• Bachelor’s degree in Life Science, Engineering, or a related field.
• Minimum of 5 years of Quality Engineering/Quality Assurance experience in medical device, pharmaceutical, or biotech manufacturing.
• Minimum of 3 years leading others or project management; direct people management preferred.
• Experience leading external regulatory audits (e.g., FDA, ISO).
• Proficiency in Six Sigma or Lean Manufacturing is desirable; Certified Quality Engineer preferred.
• Travel requirements: up to 10%.
• Knowledge of cGMP, cGDP, and relevant regulatory standards (US and OUS) for tissue, medical devices, and/or biologics.
• Knowledge of statistical sampling and analysis, Root Cause Analysis (RCA) methodologies.
• Proficiency with MS Office Suite (including Smart Sheet, Visio, Project).
• Excellent communication, interpersonal, and team-building skills; strong problem-solving and attention to detail.

Benefits

• Health, Dental, Vision insurance.
• Matching 401(k) retirement plan.
• Paid Time Off and 9 Paid Holidays + 3 Floating Holidays.
• Dependent Care and Medical Flexible Spending Accounts.
• Tuition Reimbursement and Paid Parental/Caregiver Leave.
• Basic and Supplemental Life Insurance, Employee Stock Purchase Plan, Disability Insurance.

Pay

Salary range: $113,903—$142,378 USD.

Schedule

Position based in Vandalia, OH (913 Industrial Drive).