AxogenÌýisÌýcommittedÌýto building and maintaining a strong andÌýgratifyingÌýcompany 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!ÌýÌý
AxogenÌýis the leadingÌýcompany revolutionizing theÌýscience of nerve repair.ÌýWe areÌýpassionate about helping to restore function and quality of life to patients with physical damage or discontinuity to peripheral nerves.ÌýÌý
ContributeÌýtoÌýpositively impactingÌýlives whileÌýworkingÌýfor a company that respects, recognizes, andÌývalues allÌýteam members!Ìý
AxogenÌýis an equal opportunity employer and does not discriminate against applicantsÌýon the basis ofÌýrace, color, creed, religion, ancestry, age, sex, marital status, national origin, disability or veteran status.Ìý
ÌýWhy you’ll love working atÌýAxogen:Ìý
- Friendly, open,ÌýandÌýfunÌýteam cultureÌýthat values uniqueÌýperspectivesÌý
- Company-wide dedicationÌýto profoundly impacting patients’ livesÌý
- Comprehensive, high-quality benefitsÌýpackage effective on date of hireÌý
- EducationalÌýassistanceÌýavailable for all employeesÌý
- Matching 401(k)ÌýretirementÌýplanÌý
- Flexible working hoursÌý
- Paid holidays,Ìýincluding floating holidays,Ìýto be used at your discretionÌý
- Employee Stock Purchase PlanÌý
- Referral incentive programÌý
Axogen is hiring for a QA Director in Vandalia, OH!
Job Summary of the Director, Quality Assurance
The 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. Ìý
Requirements of the Director, Quality Assurance
- BA, MS or PhD with at least 10 years’ experience in a quality assurance or related role in the biologics or pharmaceutical industry is required
- Demonstrated 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 audits
- Demonstrate experience in successful hiring and management of a quality or related organization/group.Ìý
- Excellent oral and written communication skillsÌý
- Excellent interpersonal and team-building skills
- Ability to work independently, analyze and work with attention to detail, process and prioritize sensitive information and problem solve
- Ability to exercise creativity and judgmentÌý
- Experience with human tissue products or implantable medical devices is desirableÌý
- Experience with quality functions for biologics is required
- Experience with Six Sigma and/or Lean Manufacturing desirable complex
- Familiar with preparation of and guidelines for Chemistry, Manufacturing, and Controls (Module 3) worldwide regulatory submissions desirable. Ìý
Responsibilities of the Director, Quality Assurance
The specific duties of theÌýDirector, Quality Assurance include but are not limited to:
- Establishes and administers AxoGen’s Quality Management System
- Oversees all quality functions related to human tissue products, biologic products and medical devices.
- Ensures compliance with relevant domestic and international quality requirements
- Provides guidance on and administer process validation activities
- Performs risk assessments and leads investigations to address quality issues
- Performs release and disposition functions; manages and controls cGXX-manufactured intermediates and products; works with AxoGen Operations, Clinical and Translation Science staff as requiredÌý
- Represents AxoGen during external audits and inspections and ensures pre-approval inspection readinessÌý
- Participates in vendor selection, assessment and qualificationÌý
- 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 growÌý
- Develops budget for Quality Assurance departmentÌý
- 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.Ìý
- 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 ÌýExperience and judgment to plan and accomplish goals. Performs a variety of tasks. Leads and directs the work of others. Ìý
Location
913 Industrial Drive Place, Vandalia, OHÌý 45377
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Benefits/Compensation
This 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 USD
Axogen 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.ÌýThe 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.
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