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About the role
- Senior Director overseeing GCP compliance in clinical trials at Bicara Therapeutics. Managing quality assurance processes and collaborating with cross-functional teams to ensure regulatory adherence.
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.
Requirements
- 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.
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