Sr. Clinical Quality Assurance Specialist

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
• Paid holidays, including floating holidays, to be used at your discretion
• Employee Stock Purchase Plan
• Referral incentive program

Axogen Mission and Business Purpose

Our 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 Sr. Clinical Quality Assurance Specialist

Responsible for leading Clinical Quality Assurance (CQA) activities for assigned clinical development programs, including the management of audits, quality issues and investigations, and inspections. This position requires a depth of understanding and experience in GCP and compliance, leadership, communication skills, and business acumen to conduct responsibilities with minimal supervision. This position will liaise and interface with internal and external stakeholders in order to assess and support compliance with international guidelines (e.g. ICH-GCP, GCLP, and GLP), applicable international and local regulations, and corporate quality standards in the clinical development field. It will also support the maintenance, execution, and improvement of a risk-based Clinical Quality Audit Program with focus on Early Clinical and Clinical Development.

Requirements of the Sr. Clinical Quality Assurance Specialist

• Bachelor's degree required, Science or technical degree preferred
• Minimum 8 years of directly related experience in Biotech or Pharma Clinical Quality Assurance
• In-depth experience with ICH GCP E6 Guideline
• Minimum 4 years' GCP auditing experience required; GCP Auditor Certification is an asset
• Clinical Study Management or monitoring experience is an asset
• GLP or GCLP Experience is a solid asset (21CFR Part 11, 21 CFR Part 58 and OECD Principles)
• Solid knowledge of modern quality systems, risk assessment, corrective and preventive action development and execution, and other evolving principles across the global compliance
• Excellent written and verbal communication skills; the ability to effectively write and edit comprehensive documents for a variety of audiences
• Excellent interpersonal skills with a proven track record of building and maintaining strong relationships with internal and external stakeholders
• Proven ability to work effectively as a team member, including cross-functional teams
• Proven ability to multitask, to organize and prioritize workload to meet deadlines and corporate objectives in a fast-paced environment
• Proven organizational skills and attention to detail with a focus on accuracy and quality
• Self-directed and highly motivated team player with solid organizational capabilities
• Ability to travel 30 to 40%

Responsibilities of the Sr. Clinical Quality Assurance Specialist

The specific duties of the Sr. Clinical Quality Assurance Associate include but are not limited to:

• Provide professional expertise and guidance on Good Clinical Practice (GCP) and applicable regulations to clinical development teams to proactively identify compliance issues/risks and recommend mitigations
• Liaise with various Axogen Clinical functions and external parties including contract auditors and investigator sites to promote a high level of quality and consistency across and within programs; develop the risk-based audit and compliance strategy for assigned programs; assist project teams in implementing corrective and preventive actions; and enable teams to be inspection ready, in support of a culture of sustainable compliance
• Manage domestic and international audits of sites, documents, databases, vendors or internal systems in compliance with GCP and Axogen policies and procedures; assess impact of audit findings on subject safety, data integrity, and business operations. Audits conducted require advanced auditing skills and may involve technically complex assignments, including audits of high-risk studies/vendors
• Support the maintenance, execution, and improvement of a risk-based Clinical Quality Audit Program with focus on Early Clinical and Clinical Development
• Develop, review and issue of Audit Reports outlining the findings categorized according to level of risk/s and CAPA recommendations
• Review and approve deviations, change controls, and CAPAs
• Manage individual CAPAs resulting from audits and inspections to ensure issues are thoroughly evaluated (including a risk assessment, root cause analysis and effectiveness measures) and identified actions are addressed and closed in a timely manner
• Directly follow-up on observations resulting from audits of clinical suppliers, clinical sites, and internal audits and oversee timely resolution
• Identify non-compliance trends and systematic risks for assigned areas of responsibilities and escalate to senior QA management
• Create and revise of GCP-compliant Clinical Research SOPs
• Develop and provide routine and as needed GCP training to staff
• Serve as the primary point of QA contact for staff of the Clinical Organization ensuring the timely communication of quality risk and compliance as related to GCP/GCLP/GLP and Quality
• Support the conduct of pre-inspections, mock-inspections and related follow-up activities, and review of inspection requested information
• Other duties as assigned

Location

111 West Oak Ave., Tampa, FL 33602

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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 + 3 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

$100,532-$125,665 USD

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.