This position in located onsite in San Diego, CA
This leadership position is central to establishing and upholding our Quality Management System (QMS), fostering a quality-driven culture, and ensuring compliance with global GxP regulations (FDA, EU, and other countries). This role will oversee GxP activities across internal functions and external partnerships with CDMOs/CROs, managing vendor qualifications, audits, and quality agreements. You’ll collaborate across teams to address compliance issues and implement proactive measures. Primary responsibilities include all aspects of quality assurance in cGMP manufacturing, CTM release, labeling, distribution, and continuous improvement initiatives.
Key Responsibilities:
- Build and guide the Quality Assurance team, fostering continuous improvement and accountability.
- Develop and implement strategic quality plans aligned with company goals and regulatory requirements.
- Collaborate with cross-functional teams to ensure adherence to quality standards throughout the product lifecycle.
- Oversee the development and maintenance of a compliant QMS in line with GMP standards.
- Establish quality metrics, KPIs, and dashboards to monitor QMS performance.
- Ensure all cGMP manufacturing processes, documentation, and procedures align with global regulatory standards (FDA, EMA, etc.).
- Conduct regular audits and inspections of GxP vendors and review/approve key manufacturing documents.
- Develop and maintain quality documents, including SOPs and work instructions.
- Lead GxP training initiatives and oversee Quality System-related training (e.g., annual GMP training, change control, deviation, and CAPA).
- Identify and mitigate quality risks through proactive strategies and corrective actions.
- Lead investigations into quality issues, deviations, and non-conformances, ensuring thorough documentation and timely resolution.
- Develop and deliver training programs to ensure staff are knowledgeable about GMP standards and quality requirements.
- Stay updated on industry trends, regulatory changes, and best practices, sharing insights across the organization.
- Drive initiatives to continuously improve product quality, compliance, and operational efficiency.
- Implement and monitor KPIs to measure and optimize quality performance.
Qualifications:
- Bachelor’s degree in Chemistry or a related life science field; advanced degree preferred.
- Minimum of 15 years in Quality Assurance for GMP manufacturing within biotech or pharmaceutical industries.
- In-depth knowledge of cGMP regulations, QMS, and industry best practices; familiarity with GCP, GLP, and pharmacovigilance regulations is beneficial.
- Strong communication and interpersonal skills, with the ability to collaborate effectively with internal teams and external partners (CDMOs, CROs, and vendors).
- Experience hosting regulatory inspections (FDA, EMA, etc.) is highly desirable.
- Strong organizational skills, critical thinking, and meticulous attention to detail.
