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Job Summary of the Manager, Quality Assurance

The Manager, Quality Assurance is responsible for establishing, administering, and maintaining Quality Assurance (QA) processes, systems, and tasks in compliance with current Good Manufacturing Practice (cGMP), current Good Distribution Practice (cGDP), and applicable domestic and international standards for tissue, biologic, and medical device products. The Manager, Quality Assurance manages quality departments at Axogen's facilities, including Processing Centers (DPC or APC) or the Burleson Distribution Center (BDC).

The Manager, Quality Assurance collaborates closely with Operations to provide Quality Assurance (QA) support, ensuring that the organization maintains high standards of compliance and fosters a culture of continuous improvement in manufacturing, processing, systems, testing, and product distribution functions. This role is responsible for developing and executing quality strategies that align with company goals and industry best practices. By working cross-functionally, the Manager, Quality Assurance helps implement scalable processes that support organizational growth and ensure quality standards are met for receiving, storage, processing, shipping, and distribution activities.

Requirements of the Manager, Quality Assurance

• Bachelor's Degree in Life Science or Engineering discipline and/or a related field.
• Minimum of 5 years Quality Engineering/Quality Assurance experience in medical device, pharmaceutical, or biotech manufacturing.
• Minimum 3 years of 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 are up to 10%
• Knowledge of current Good Manufacturing Practices (cGMP) and relevant regulatory standards, guidelines, and regulations, both in the US and OUS for tissue, Medical Devices and/or Biologics.
• Knowledge of statistical sampling and analysis.
• Knowledge of Root Cause Analysis (RCA) methodologies.
• Ability to proficiently use MS Office Suite, including Microsoft Smart Sheet, Visio and Project.
• Excellent communication, interpersonal, and team-building skills.
• Strong problem-solving skills and the ability to exercise creativity and judgment.
• Ability to work independently, analyze and work with attention to detail, process and prioritize sensitive complex information and problem solve.

Responsibilities of the Manager, Quality Assurance

The specific duties of the Manager, Quality Assurance include but are not limited to:

• Manages Quality Assurance operations at DPC, APC, or BDC, ensuring compliance with domestic and international quality standards for human tissue, biologic, and medical device products.
• Establishes, implements, and maintains Axogen's Quality Management Systems (QMS) ensuring alignment with
• cGMP, cGDP, QSR, ISO13485, MDD, AATB and other applicable standards.
• Recruits, develops, and manages quality assurance team members, fostering a positive workplace culture and building high-performing team.
• Provides strategic leadership, coaching, guiding performance development, succession planning, and ensuring alignment with company objectives while achieving goals and maintaining regulatory compliance.
• Ensures compliance with FDA, ISO, and other relevant regulatory bodies. Acts as the subject matter expert for tissue, medical device, and biologic regulations.
• Represents Axogen during external audits and inspections. Ensures pre-approval inspection readiness and conducts internal audits and risk assessments.
• Collaborates with Operations, Finance, and Material Handling teams to ensure Quality Assurance support during GMP activities and to meet product demand and regulatory requirements.
• Leads quality planning, verification/validation, and continuous improvement activities.
• Investigates and reduces non-conformances and optimizes inspection processes.
• Determines quality improvement parameters using improvement methodologies relevant to processing activities.
• Performs risk assessments, leads investigations to resolve quality issues, and oversees the qualification and validation activities at distribution and processing sites.
• Trains staff on quality policies and procedures. Facilitates communication regarding changes in facilities, processes, and materials.
• Prepares quality metrics, reports, and presentations by analyzing data and making recommendations to stakeholders.
• Leverages analytical skills, tools and best practices to work across business functions to identify opportunities to do things better, eliminate waste, reduce cost, and find workflow efficiencies; prioritizing opportunities that help achieve strategic imperatives.

The specific duties of the Manager, Quality Assurance at APC assigned to own Cleanroom Processing and Laboratory Operations include but are not limited to:

• Oversight of Avance Starting Material, Drug Substance, and Drug Product Processing processes, including weekly room release, environmental monitoring execution, sample management, gowning for the cleanrooms, process validation, and quarterly dose audits.
• Serves as the quality assurance subject matter expert for computer systems relating to this area, including but not limited to Tulip, laboratory information management systems, and particle monitoring systems.

The specific duties of the Manager, Quality Assurance at APC assigned to own Drug Product, Facility, and Technical Operations include but are not limited to:

• Oversight of qualification, maintenance, and calibration activities for equipment, facilities, and utilities; labeling quality review and disposition of drug product, drug product chain of custody, and ancillary systems (including but not limited to: cleaning & sterilization, cleaning solution preparation, and environmental cleaning)
• Serves as the quality assurance subject matter expert for computer systems relating to these areas, including but not limited to maintenance management systems, cleaning & sterilization systems, building monitoring systems, and security access control systems.

Location

913 Industrial Drive Place, Vandalia, OH  45377

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