Director, Quality Assurance

Axogen is committed to building and maintaining a strong and gratifying company culture that fosters 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! Axogen is an equal opportunity employer and does not discriminate against applicants on the basis of race, color, creed, religion, ancestry, age, sex, marital status, national origin, disability or veteran status. Why you'll love working at Axogen: Friendly, open, and fun team culture that values unique perspectives Company-wide dedication to profoundly impacting patients' lives Comprehensive, high-quality benefits package effective on date of hire Educational assistance available for all employees Matching 401(k) retirement plan Flexible working hours Paid holidays, including floating holidays, to be used at your discretion Employee Stock Purchase Plan Referral incentive program If you want to see how you can impact lives at Axogen, take a look at these inspiring patient stories: https://www.axogeninc.com/patient-stories/ Axogen Mission and Business PurposeOur business purpose is to restore health and improve quality of life by making restoration of peripheral nerve function an expected standard of care. We aim to lead the markets we serve by always requiring the solutions we offer patients and caregivers provide an improved benefit-to-risk profile as compared to existing standards of care. To ensure we deliver improved benefit-to-risk solutions, we will guide and expect the market and design requirement specifications underlying our engineering, business development, and clinical research activities, objectively target advancements in standards of care.Job Summary of the Director, Quality AssuranceThe Director, Quality Assurance will be a key member of the AxoGen Leadership team with responsibility for establishing and administering all Quality functions related to cGXX (cGMP, QSR and cGTP) operations. The Director, Quality Assurance will provide quality oversight and support AxoGen's manufacturing, processing, testing and product distribution functions. The position requires domestic and international travel, primarily to AxoGen locations to ensure compliance with domestic and international regulations. Requirements of the Director, Quality AssuranceBA, MS or PhD with at least 10 years' experience in a quality assurance or related role in the biologics or pharmaceutical industry is requiredDemonstrated knowledge of cGXXs and relevant regulatory guidelines in the US and OUS.Familiarity with ISO 13485 requirements for the design and manufacture of medical devices.Experience at all phases of development, including commercialization.Experience in leading external regulatory auditsDemonstrate experience in successful hiring and management of a quality or related organization/group. Excellent oral and written communication skills Excellent interpersonal and team-building skillsAbility to work independently, analyze and work with attention to detail, process and prioritize sensitive information and problem solveAbility to exercise creativity and judgment Experience with human tissue products or implantable medical devices is desirable Experience with quality functions for biologics is requiredExperience with Six Sigma and/or Lean Manufacturing desirable complexFamiliar with preparation of and guidelines for Chemistry, Manufacturing, and Controls (Module 3) worldwide regulatory submissions desirable. Responsibilities of the Director, Quality AssuranceThe specific duties of theDirector, Quality Assurance include but are not limited to:Establishes and administers AxoGen's Quality Management SystemOversees all quality functions related to human tissue products, biologic products and medical devices.Ensures compliance with relevant domestic and international quality requirementsProvides guidance on and administer process validation activitiesPerforms risk assessments and leads investigations to address quality issuesPerforms release and disposition functions; manages and controls cGXX-manufactured intermediates and products; works with AxoGen Operations, Clinical and Translation Science staff as required Represents AxoGen during external audits and inspections and ensures pre-approval inspection readiness Participates in vendor selection, assessment and qualification Works with internal and external technical teams (process, analytical, formulation development, quality control)Recruits, develops, and manages the Quality Assurance department as the company's pipeline and development activities grow Develops budget for Quality Assurance 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 Leadership team, the Director is expected to participate in operational and strategic discussions that impact the entire organization.Other duties as assigned Experience and judgment to plan and accomplish goals. Performs a variety of tasks. Leads and directs the work of others. Location913 Industrial Drive Place, Vandalia, OH 45377#LI-AC1Benefits/CompensationThis position is eligible for an annual bonus. Benefits offered for this position include Health, Dental, Vision, Matching 401K, Paid Time Off, 9 Paid Holidays + 2 Floating Holidays, Dependent Care Flexible Spending Accounts, Medical Flexible Spending Accounts, Tuition Reimbursement, Paid Parental Leave, Paid Caregiver Leave, Basic Life Insurance, Supplemental Life Insurance, Employee Stock Purchase Plan, and Disability Insurance, as described in more detail in summary plan descriptions.Salary Range$144,707-$180,884 USDAxogen is on a hybrid work schedule for some of our positions based out of our headquarters in Florida, with 3 days in office and 2 days remote. The hybrid work schedule does not include sales or facilities in Ohio or Texas.Axogen follows healthcare system guidelines with respect to credentialing, vaccinations and other employment/compliance related requirements, as well as CDC guidance. Axogen reserves the right to amend its policies from time to time in its sole discretion.If you know someone who would be a great candidate for this position, or any others, just copy and send this link! https://grnh.se/cc84962d2us