Axogeniscommittedto building and maintaining a strong andgratifyingcompany culture that fosters a work-life balance and professional growth. Our hands-on and personal approach makes transitioning to a new job a seamless and enjoyable process. Most benefits are effective on day one!
Axogenis the leadingcompany revolutionizing thescience of nerve repair.We arepassionate about helping to restore function and quality of life to patients with physical damage or discontinuity to peripheral nerves.
Contributetopositively impactinglives whileworkingfor a company that respects, recognizes, andvalues allteam members!
Axogenis an equal opportunity employer and does not discriminate against applicantson the basis ofrace, color, creed, religion, ancestry, age, sex, marital status, national origin, disability or veteran status.
Axogen is hiring for an Vice President, Quality Assurance in Alachua or Tampa, FL!
Job Summary of the Vice President, Quality Assurance
The VP, Quality Assurance will be a key member of the Axogen's Senior Leadership team with responsibility for establishing and administering all Quality functions related to CGXX (CGMP, CGCP QSR and CGTP) operations. Axogen's Quality Assurance team function's as an agile business partner while maintaining the independence required to assure excellence in our quality systems and processes. Axogen's product portfolio includes tissue, medical device, and biological products. The VP, Quality will design, develop, implement and monitor the effectiveness of the long-term, mid-term and short-term strategies to ensure Axogen's quality system is maintained in compliance with federal, state and international, regulations for multiple product categories.
Axogen is passionate about restoring nerve function and quality of life to patients with peripheral nerve injuries. We are building the preeminent peripheral nerve company that is led by clinical science and the ability to transform and improve patients' lives. As the leader in peripheral nerve repair Axogen has been on the forefront of defining the regulatory pathway for converting tissue-based products to a biological product through a Biologic License Application (BLA) in the US. The successful candidate will have had experience working in a regenerative medicine (biologics or pharma) environment and partnering with our regulatory, clinical, operations and other related teams to establish, refresh and maintain compliance with these evolving requirements and continue to chart related paths in international markets
The position requires domestic and international travel, primarily to Axogen locations to ensure compliance with domestic and international regulations. The position is located at Axogen's Corporate Office in either Alachua or Tampa, Florida.
Requirements of the Vice President, Quality Assurance
Masters degree, and a PhD preferred, with at least 10 years' experience in a quality assurance or related role.
Demonstrated knowledge of cGXXs and relevant regulatory guidelines, both in the US and OUS.
Familiarity with ISO 13485 requirements for the design and manufacture of medical devices.
Familiarity with 21 CFR Part 11, Part 820, Part 1271 and Parts 210/211 regulations desirable
Experience at all phases of development, including commercialization.
Experience in leading external regulatory audits
Demonstrate experience of successful hiring and management of a quality team in multiple locations
Excellent oral and written communication skills
Excellent interpersonal and team building skills
Ability to work independently, analyze and work with attention to detail, process and prioritize sensitive complex information and problem solve
Ability to exercise creativity and judgment
Experience with human tissue products, biological products or implantable medical devices desirable
Experience with Six Sigma and/or Lean Manufacturing desirable
Familiar with preparation of and guidelines for Chemistry, Manufacturing and Controls (CMC) worldwide regulatory submissions desirable.
Familiar with American Association of Tissue Banks (AATB) and National Association of Boards of Pharmacy (NABP) standards/guidelines desirable
Responsibilities of the Vice President, Quality Assurance
The specific duties of the TITLE include but are not limited to:
Recruit, develop, and manage the Quality Assurance team as the company's pipeline and development activities grow
Designs, implements, and tracks the success of a Quality program driven by statistics and analytics that ensures Axogen is able to meet the high-quality standards.
Establish and administer Axogen's Quality Management System
Is the subject matter expert on quality initiatives for both internal and external purposes.
Maintains an awareness of and, adjust as necessary, to internal and external market conditions that impact the delivery of services
Keeps abreast of and ensures executive management are aware of issues and concerns that impact Axogen, providing solutions to address identified issues
Works with Operations and other Axogen departments to ensure adequate systems are implemented to ensure product quality and regulation compliance.
Provides guidance to Axogen staff on quality system development, validation methodology, facility compliance and
Responsible for all quality functions related to human tissue products, biological products and medical devices.
Develop and maintains the budget for Quality department.
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.
As a key and senior member of the Axogen Senior Leadership team, the Vice President is expected to participate in operational and strategic discussions that impact the entire organization.
Other duties as assigned
Depending on business needs, position will likely include some weekend work and possible on-call assignments. This position may require the use of personal protective equipment during various tasks/activities including but not limited to, gloves, masks and safety glasses. This position is an office position but will require time on processing/manufacturing floor as an observer of practices. Travel Requirements are up to 40%.
This position requires frequent standing, walking, carrying, bending, stooping, grasping and reaching. Must possess the ability to lift/carry up to 30 pounds on a regular basis and occasionally up to 60 pounds. Manual dexterity required to grasp objects utilizing hand/finger coordination. Axogen facilities include controlled environment where gowning is required and facilities that are controlled by HVAC. Frozen products require handling of dry ice with applicable PPE.