Sr. Clinical Quality Assurance Specialist

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

• Bachelors 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