Senior Director Quality (remote)

Senior Director, Quality

The Senior Director of Quality will lead our quality team and play a critical role in ensuring that our drug development activities meet regulatory requirements and adhere to the highest quality standards. This position offers the opportunity to establish a Quality function and advise our leadership team on all aspects of Quality, from strategy to implementation. This position will work with other organizational teams to provide quality oversight and GXP (GCP/GLP/GMP) expertise throughout the product lifecycle, from preclinical and clinical development through commercialization.

Job Responsibilities:

• Develop phase-appropriate quality operating models in accordance with risk-based compliance guidance.
• Provide quality oversight for GXP (GCP/GLP/GMP) and pharmacovigilance activities and ensure organizational compliance.
• Partner with Regulatory Sciences to ensure compliance on regulatory submissions to FDA and other health authorities.
• Plan and conduct/coordinate GXP (GCP/GLP/GMP) audits, to ensure inspection readiness both internally and at vendors, in accordance with established timelines.
• Continue to build and expand the company’s quality systems to ensure that they are optimally designed and managed.
• Oversee major/critical deviation investigations to ensure minimal risk to product quality, efficacy, and safety.
• Manage the development and reporting of quality metrics, and periodic reporting describing compliance trends and any areas of risk with associated mitigation plans, including the annual quality review with the leadership team.
• Lead and facilitate quality-related continuous improvement initiatives and activities, performing gap analysis and risk communication.
• Ensure all quality agreements are effectively negotiated to meet the near- and long-term needs of the company in a cost-efficient manner.
• Oversee generating performance metrics and trends, including site metrics for investigation/CAPA, etc.
• Act as a trusted advisor to the leadership team by providing compliance guidance through collaborative review.
• Drive the quality culture throughout the organization.

Required Skills & Qualifications:

• Bachelor’s degree in a scientific discipline. Advanced degree (MS, PharmD, MD or PhD) preferred.
• 15+ years of experience of quality assurance and regulatory compliance experience in the biotech or pharmaceutical industry, including experience in oncology drug development.
• Demonstrated track record of managing quality systems to enable successful regulatory filings and drug or biologics approvals.
• Quality leadership and team management experience.
• Experience performing audits of critical suppliers and CMOs.
• Expert knowledge of U.S. GCP/GLP/GMP and pharmacovigilance regulations and quality guidelines, including industry best practices and standards in regulatory affairs and quality assurance. Knowledge of relevant Asia Pacific regulations and guidelines highly desired.
• Experience serving as a sponsor representative during a regulatory authority audit and communicating directly with an inspector.
• Substantial experience with CMC, clinical, and preclinical development, and regulatory submissions.
• In-depth understanding of the drug development, product commercialization, and life cycle management processes.
• Demonstrated proficiency in departmental budgeting, organizing, and planning.
• Demonstrated leadership competencies and strategic business perspective.
• Ability to thrive in a fully virtual/remote work environment with some business travel (up to 20%).
• Must be located in and authorized to work in the United States today and in the future.

Elevation Oncology is an equal opportunity employer and encourages applications from all individuals.

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