Director of Quality Assurance
BioPhase, San Diego, TX, United States
Hybrid onsite, 2/3 days a week in San Diego, CA
Position Overview
Seeking a senior-level Quality leader to oversee and strengthen quality systems across drug development activities. This role is responsible for driving compliance with global GxP standards and ensuring effective quality oversight of both internal functions and external partners. The individual will play a key role in building scalable processes, supporting inspection readiness, and promoting a culture of quality and continuous improvement. Key Responsibilities
Lead development and execution of quality strategy aligned with regulatory expectations and business objectives Oversee and enhance core quality systems (e.g., SOPs, change control, CAPA, training, documentation) Ensure GxP compliance across internal operations and external vendors, maintaining audit readiness Manage audits, inspections, and vendor oversight activities; address compliance findings as needed Support preparation and review of manufacturing and clinical documentation Partner cross-functionally to track quality metrics and drive process improvements Identify risks and implement mitigation strategies to support product quality and operational efficiency Qualifications
Bachelor’s degree in a scientific discipline; advanced degree preferred 10+ years of Quality experience within pharmaceutical or biotech environments Strong background supporting cGMP activities within small molecule development Experience with regulatory inspections and global quality standards
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Seeking a senior-level Quality leader to oversee and strengthen quality systems across drug development activities. This role is responsible for driving compliance with global GxP standards and ensuring effective quality oversight of both internal functions and external partners. The individual will play a key role in building scalable processes, supporting inspection readiness, and promoting a culture of quality and continuous improvement. Key Responsibilities
Lead development and execution of quality strategy aligned with regulatory expectations and business objectives Oversee and enhance core quality systems (e.g., SOPs, change control, CAPA, training, documentation) Ensure GxP compliance across internal operations and external vendors, maintaining audit readiness Manage audits, inspections, and vendor oversight activities; address compliance findings as needed Support preparation and review of manufacturing and clinical documentation Partner cross-functionally to track quality metrics and drive process improvements Identify risks and implement mitigation strategies to support product quality and operational efficiency Qualifications
Bachelor’s degree in a scientific discipline; advanced degree preferred 10+ years of Quality experience within pharmaceutical or biotech environments Strong background supporting cGMP activities within small molecule development Experience with regulatory inspections and global quality standards
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