Associate Director Of Quality Assurance Clinical Operations

Our client is pioneering advancements in healthcare by leveraging gene therapy to treat and potentially cure genetic disorders. Their innovative technology addresses the root cause of diseases, providing transformative treatments that go beyond symptom management. With a team of world-class scientists and a steadfast commitment to innovation, they are developing safe, effective, and personalized therapies that bring hope to patients and their families. Join them in their mission to revolutionize medicine and improve lives globally. This role can be onsite or remote in Durham, NC.

Key Responsibilities of the Associate Director, Quality Operations:

• Partner with Clinical, CMC, and non-clinical development teams, external vendors, and investigator sites to provide GXP QA oversight, including development of risk assessments and quality oversight initiatives.
• Collaborate with external vendors and internal teams to provide GXP and QA expertise, ensuring project objectives are met in a compliant and timely manner.
• Assess compliance of vendors, investigator sites, and study activities with study protocols, SOPs, and regulatory requirements.
• Develop and implement the internal/external GXP audit program, including scheduling, consultant oversight, and audit report review and approval.
• Lead the Significant Quality Issues management system for assigned studies, including root cause assessment and remediation.
• Ensure timely escalation of quality issues to Leadership.
• Manage GXP document management and training initiatives via the Veeva Vault platform.
• Promote and maintain a quality culture and awareness towards Data Integrity and Good Documentation Practices.
• Lead GXP PAI readiness activities with internal operational and Quality leadership.
• Establish site GXP quality metrics and processes for tracking and reporting.
• Contribute to periodic Quality Management Review and Quality Council processes.

Qualifications of the Associate Director, Quality Operations:

• Experience with AAV Gene Therapy preferred.
• Bachelor’s Degree in life sciences required.
• Minimum ten (10) years’ experience in the biotech or pharma industry, with biologics and/or gene therapy experience preferred.
• Quality assurance pharmaceutical experience, with clinical research, GCP, GMP, and QA compliance experience.
• Knowledge of pre-clinical and clinical development programs and clinical trial processes.
• CQA Certification preferred.
• Experience in designing, developing, and overseeing Quality Management Systems. Experience with VeevaVault preferred.
• Knowledge of FDA regulations, ICH standards, and other regulatory requirements.
• Ability to manage multiple projects in a dynamic and fast-paced environment.
• Self-motivated, resourceful, well-organized, highly dependable, efficient, and detail-oriented.
• Ability to work collaboratively in a team environment and independently with minimal supervision.
• Hands-on, get-it-done approach with demonstrated cross-functional capabilities.
• Excellent written and verbal communication skills and strong QA technical knowledge.
• Ability to interact effectively with people at all levels of the organization and with external vendors.

Compensation of the Associate Director, Quality Operations:

• Pay Range: $120,000-$200,000
• Comprehensive benefits package including Medical, Dental, Vision, 401K, PTO, Sick Leave as required by law, and Holidays.

Applications for this job will be accepted for at least 30 days from 3/21

Keywords: Gene Therapy, Genetic Disorders, Biotechnology, Molecular Biology, Biopharmaceuticals, Quality Assurance, GXP, Veeva Vault, FDA Regulations, Clinical Trials, Quality Management Systems, AAV, CQA Certification

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