Bicara Therapeutics · 2 hours ago
Senior Director, GCP Quality Assurance
Boston, MA
Full-time
Hybrid
Director/Executive
$255K/yr - $295K/yr
10+ years expBicara Therapeutics is a clinical-stage biopharmaceutical company committed to bringing transformative bifunctional therapies to patients with solid tumors. 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, ensuring quality and compliance with regulatory requirements and industry standards.
BiopharmaBiotechnologyLife ScienceOncologyTherapeutics
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
Qualification
Required
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
Preferred
Certification in quality assurance (e.g., Certified Quality Auditor) and/or GCP (e.g., Certified Clinical Research Professional) is desirable
Company
Bicara Therapeutics
Bicara Therapeutics develops dual-action cancer therapies, combining targeted treatments with tumor modulators for enhanced impact. It is a sub-organization of Biocon.
51-200 employees
Funding
Current Stage
Public CompanyTotal Funding
$313MKey Investors
Biocon
2024-09-13IPO
2023-12-12Series C· $165M
2023-03-06Series B· $108M
Leadership Team
Claire Mazumdar
Chief Executive Officer
David Raben
CMO, Bicara Therapeutics
Recent News
2026-01-13
2026-01-12
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