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The Quality Assurance Manager (QA Manager) will have responsibility for establishing, administering and maintaining the site Quality Management System related to processes, systems and tasks under current Good Distribution Practice (cGDP) and applicable parts of current Good Manufacturing Practice (cGMP). Responsible to ensure site compliance to these requirements for biologics, for Advanced Therapy Medicinal Product (ATMP) for tissue and for medical devices. In your role you will ensure that Axogen’s quality management systems (QMS) are understood and applied to ensure site-wide compliance with domestic and international standards and regulations pertaining to the labelling, receiving, storage, shipping, and distribution of products to/from Axogen’s Burleson Distribution Center (BDC). The QA Manager will have overall quality and compliance responsibility for BDC, located in Burleson, TX.
The specific duties of the Quality Assurance Manager include, but are not limited to:
Establishes, implements, and maintains Axogen’s Site Quality Management System at BDC
Oversees the quality department at BDC related to release and distribution of labeled of ATMP human tissue products, biologic products and medical devices.
Support sthe site to ensure adherence to applicable ISO, FDA, and AATB requirements for domestic and international product distribution.
Leads daily quality activities of a centralized distribution center including certain cGMP operations related to labeling and returns management.
Conducts audits and reviews/analyzes data and documentation requiring a wide degree of creativity and latitude.
Collaborate cross-functionally to build sustainable and scalable processes to support growth.
Works with Operations Engineers to support risk assessments and investigations related to non-conformances or complaints.
Represents Axogen during external audits and inspections.
Supports site preparation for inspection readiness for general inspections as well as for future pre-approval inspections.
Recruits, develops, and manages the Quality Assurance department as the company’s pipeline and development activities grow.
Follows and reinforces corporate quality management systems (NCR/CAPA, Training, Validation, Returns, Complaint Handling, Audit, Change Control, Etc.) throughout the site.
Axogen is a dynamic environment and each employee may be asked to assist in work areas outside of their usual duties. This is an expectation of every employee and it allows for future growth opportunities.
Leads and directs the work of others and be hands-on if necessary.
Performs all other duties as assigned by Supervisor.
Bachelor’s Degree in Life Sciences discipline, Engineering, or other technical field.
Minimum of 8 years’ experience in quality assurance leadership role in life sciences industry.
Demonstrated knowledge of current Good Distribution Practice (cGDP) and current Good Manufacturing Practice (cGMP) and relevant regulatory standards, guidelines and regulations, both in the US and OUS for ATMP tissue products, biologics, and/or medical devices.
Experience with Current Good Tissue Practices under 21 CFR 1271 and AATB Standards is a plus.
Experience in leading external regulatory and/or third-party audits, i.e. FDA, ISO, etc.
Demonstrated experience of building high-performing quality and/or related organization teams.
Excellent oral and written communication skills.
Excellent interpersonal and team building skills.
Ability to exercise creativity and judgment.
Experience with Six Sigma and/or Lean Manufacturing desirable.
Desirable but not required:
Certified Quality Engineer
Certified Quality Auditor
Certified Tissue Bank Specialist
Internal Number: 3396
About Axogen, Inc.
Axogen (AXGN) is the leading company focused specifically on the science, development and commercialization of technologies for peripheral nerve regeneration and repair. We are passionate about helping to restore peripheral nerve function and quality of life to patients with physical damage or discontinuity to peripheral nerves by providing innovative, clinically proven and economically effective repair solutions for surgeons and health care providers.