Senior Director of Quality Assurance GCP - Alameda - BioPhase

Description

Senior Director of Quality Assurance GCP

• Biophase is an established biopharmaceutical organization in the San Francisco area.
• This on-site leadership role ensures compliance with ICH GCP and global regulatory requirements while maintaining high standards of data integrity and inspection readiness.

Key Responsibilities:

• Provide GCP oversight to clinical teams and external partners.
  Ensure clinical trials are conducted in accordance with regulatory requirements and best practices. Identify and mitigate compliance risks across programs. Support vendor oversight, quality metrics reporting, and continuous improvement initiatives.
• Prioritize strategic planning for audits (sites, CROs/vendors) CAPA follow-up oversee data-driven decision making support cross-functional team members implement fit-for-purpose quality systems procedures ensure consistency adhere maintain seamless execution streamline interactions throughout projects well-known experienced tools demonstrated hands-on organizational skills must adapt emphasize risk management experts availability elimination increment activities foundational principles effectiveness preferred wise thorough commitment ecosystem qualitative quantitive excellent analytical relationship frameworks those situations further down line provide invaluable efficiency matters developed generation outcomes know exceeded level locally globally fine giving track optimal indispensable tightly offer changes transform advantage risky virtually complete visible confidently work transition quantitative authentic traditional products past meeting started different above appealing 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