Senior Director, GCP Quality Oversight

Role Summary

The Senior Director, GCP Quality Oversight will lead the development, maintenance, and oversight of GCP activities for company-sponsored clinical trials. The role ensures quality and regulatory compliance with Standard Operating Procedures, applicable regulatory requirements (US FDA, ICH, EU and country-specific), and current industry standards. This position is based in Boston with a hybrid schedule (three in-office days per week).

Responsibilities

• Ensure that all clinical trial activities comply with GCP guidelines, international regulations (e.g., ICH-GCP), and applicable laws.
• Conduct thorough reviews of study-related documentation, including protocols, investigator brochures, informed consent forms, and CSRs, to verify compliance with GCP requirements.
• Plan, conduct, and/or participate in internal audits and external inspections to assess GCP compliance and identify areas for improvement.
• Develop and deliver internal training programs on GCP principles, regulations, and best practices for relevant stakeholders
• Collaborate with cross-functional teams to identify potential internal or external risks to GCP compliance and develop mitigation strategies to address them effectively.
• Maintain and enhance Bicara Therapeutics’ QMS by implementing processes and procedures that ensure consistent adherence to GCP standards throughout the clinical trial lifecycle.
• Investigate deviations, non-compliances, and quality issues related to GCP and develop CAPAs to prevent recurrence and improve processes.
• Evaluate and monitor the performance of third-party vendors, including contract research organizations (CROs) to ensure compliance with GCP requirements.
• Drive continuous improvement initiatives to enhance the efficiency, effectiveness, and quality of GCP-related processes and procedures.

Qualifications

• Bachelor's degree in life sciences, pharmacy, nursing, or a related field.
• Minimum of 10 years of experience in quality assurance within the pharmaceutical/biotech industry, with a focus on GCP compliance.
• SME in GCP guidelines, ICH-GCP, FDA regulations, and other relevant regulatory requirements.
• Experience conducting GCP audits, inspections, and vendor qualifications/assessments.
• Excellent communication and interpersonal skills, with the ability to collaborate effectively across departments and with external stakeholders.
• Detail-oriented mindset with a proactive approach to problem-solving and decision-making.
• Certification in quality assurance (e.g., Certified Quality Auditor) and/or GCP (e.g., Certified Clinical Research professional) is desirable.