Director of Quality Assurance
BioPhase, WorkFromHome, CA, United States
BioPhase Solutions specializes in recruiting top talented professionals for the San Diego County Scientific community. We are currently looking for an HYBRID Sr./Director, QA to work for a leading San Diego clinical-stage biotech company.
Responsibilities
- Develop and implement the overall Quality Assurance strategy aligned with corporate goals and global regulatory standards
- Lead the design, implementation, and continuous improvement of the Quality Management System (QMS)
- Ensure compliance with global GxP regulations (GMP, GLP, GCP) across internal operations and external partners (CDMOs, CROs)
- Oversee core quality systems including SOP management, change control, CAPA, documentation control, and training programs
- Manage internal and external audits, regulatory inspections, and vendor qualification activities
- Drive inspection readiness and ensure timely resolution of compliance findings
- Oversee preparation and approval of GMP documentation, including batch records, validation reports, and clinical trial material (CTM) documentation
- Partner with Regulatory Affairs and cross-functional teams to support regulatory submissions and inspections
- Establish and monitor quality metrics, KPIs, and reporting dashboards to track QMS performance
- Lead risk assessments and CAPA implementation to proactively address quality risks
- Promote a strong quality culture and continuous improvement initiatives across the organization
Requirements
- Bachelor’s degree in Chemistry, Biology, or related life sciences field (advanced degree preferred)
- 10-15+ years of Quality Assurance experience within pharmaceutical or biotech environments
- Strong experience supporting cGMP manufacturing in small molecule drug development
- Extensive knowledge of global GxP regulations and quality systems
- Demonstrated experience supporting regulatory inspections and audits (FDA, EMA)
- Experience overseeing CDMO/CRO quality and external vendor compliance
- Strong leadership, organizational, and problem-solving skills with high attention to detail
- Excellent communication and collaboration skills with the ability to work cross-functionally
What we offer:
- Full support and career-development resources to help you reach your potential
- A diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act