Senior Director, GCP Quality Assurance
Scorpion Therapeutics, Boston, Massachusetts, us, 02298
Role Summary
The GCP Quality Assurance candidate will manage activities related to the development, maintenance and oversight of GCP activities related to the Clinical Trial activities sponsored by the company. The primary responsibilities will be to ensure both quality and compliance of company sponsored clinical trials with respect to Standard Operating Procedures, applicable regulatory requirements (US FDA, ICH, EU and country specific), along with current industry standards and practices. Responsibilities
Compliance Oversight: Ensure that all clinical trial activities comply with GCP guidelines, international regulations (e.g., ICH-GCP), and applicable laws. Documentation Review: Conduct thorough reviews of study-related documentation, including protocols, investigator brochures, informed consent forms, and CSRs, to verify compliance with GCP requirements. Audits and Inspections: Plan, conduct, and/or participate in internal audits and external inspections to assess GCP compliance and identify areas for improvement. Training and Education: Develop and deliver internal training programs on GCP principles, regulations, and best practices for relevant stakeholders. Risk Management: Collaborate with cross-functional teams to identify potential internal or external risks to GCP compliance and develop mitigation strategies to address them effectively. Quality Management System (QMS): Maintain and enhance Bicara Therapeutics’ QMS by implementing processes and procedures that ensure consistent adherence to GCP standards throughout the clinical trial lifecycle. Corrective and Preventive Actions (CAPA): Investigate deviations, non-compliances, and quality issues related to GCP and develop CAPAs to prevent recurrence and improve processes. Vendor Oversight: Evaluate and monitor the performance of third-party vendors, including contract research organizations (CROs) to ensure compliance with GCP requirements. Continuous Improvement: 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.
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The GCP Quality Assurance candidate will manage activities related to the development, maintenance and oversight of GCP activities related to the Clinical Trial activities sponsored by the company. The primary responsibilities will be to ensure both quality and compliance of company sponsored clinical trials with respect to Standard Operating Procedures, applicable regulatory requirements (US FDA, ICH, EU and country specific), along with current industry standards and practices. Responsibilities
Compliance Oversight: Ensure that all clinical trial activities comply with GCP guidelines, international regulations (e.g., ICH-GCP), and applicable laws. Documentation Review: Conduct thorough reviews of study-related documentation, including protocols, investigator brochures, informed consent forms, and CSRs, to verify compliance with GCP requirements. Audits and Inspections: Plan, conduct, and/or participate in internal audits and external inspections to assess GCP compliance and identify areas for improvement. Training and Education: Develop and deliver internal training programs on GCP principles, regulations, and best practices for relevant stakeholders. Risk Management: Collaborate with cross-functional teams to identify potential internal or external risks to GCP compliance and develop mitigation strategies to address them effectively. Quality Management System (QMS): Maintain and enhance Bicara Therapeutics’ QMS by implementing processes and procedures that ensure consistent adherence to GCP standards throughout the clinical trial lifecycle. Corrective and Preventive Actions (CAPA): Investigate deviations, non-compliances, and quality issues related to GCP and develop CAPAs to prevent recurrence and improve processes. Vendor Oversight: Evaluate and monitor the performance of third-party vendors, including contract research organizations (CROs) to ensure compliance with GCP requirements. Continuous Improvement: 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.
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