Senior Director, Clinical Quality Assurance
Scorpion Therapeutics, South San Francisco, California, us, 94083
Role Summary
The individual in this role is responsible for leading and managing our clinical quality systems and ensuring GCP (Good Clinical Practice) compliance across all clinical trial activities. This role will partner across the clinical development organization to establish, maintain, and enhance robust risk-based clinical quality programs that support our investigational products in development. This is a hands-on leadership role suited for someone who thrives in a fast-paced, dynamic environment and is excited to build and optimize quality systems from the ground up. Responsibilities
Quality Leadership & Strategy
Develop and implement a clinical quality assurance strategy aligned with company goals and regulatory expectations. Serve as the subject matter expert (SME) in GCP and clinical compliance regulations and guidelines (e.g., FDA, EMA, ICH). Provide quality oversight and guidance to cross-functional clinical teams and executive leadership.
Audit Program
Design, manage, and conduct internal and external GCP audits (e.g., site audits, vendor audits, TMF audits). Oversee audit findings, CAPA development, and follow-up to ensure timely resolution. Collaborate with CROs, vendors, and clinical sites to ensure quality expectations are met.
Inspection Readiness
Lead clinical inspection readiness activities for regulatory agency inspections. Serve as the CQA representative during inspections, ensuring timely and accurate responses.
SOP & Quality System Development
Establish and maintain GCP-related SOPs, policies, and quality management systems. Ensure continuous improvement of quality systems, procedures, and training programs.
Training & Compliance
Provide GCP training and ongoing education to clinical and cross-functional staff. Monitor compliance metrics and identify trends and areas for improvement.
Collaboration & Communication
Act as the liaison between QA and clinical operations, regulatory affairs, and senior leadership. Partner with external stakeholders (e.g., CROs, vendors) to ensure alignment on quality standards.
Qualifications
Preferred: BA/BSc in a scientific field with a minimum of 15 years’ experience; or MBA or MSc with a minimum of 10 years’ experience Preferred: 15 years of progressive responsibility in Quality Assurance in the Biotechnology industry with at least 10 years’ experience in a management or leadership role. Preferred: Recognized subject matter expert in GCP, GVP, and GCLP and clinical quality systems Preferred: Demonstrated ability to drive change within organizations. Skills
Demonstrated expert knowledge of FDA regulations, and ICH GCP guidelines. Familiarity with EMA and MHRA regulations Fast learner, adaptable, with enterprise viewpoint and excellent cross-collaboration and inter-personal skills. Experience managing audits and supporting regulatory inspections Strong knowledge of clinical trial processes, oncology and/or cell therapy a plus Ability to work independently and collaboratively among cross-functional teams. Ability to work efficiently, prioritize workflow, meet deadlines and balance competing priorities Education
BA/BSc in a scientific field; MBA or MSc (preferred or relevant)
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The individual in this role is responsible for leading and managing our clinical quality systems and ensuring GCP (Good Clinical Practice) compliance across all clinical trial activities. This role will partner across the clinical development organization to establish, maintain, and enhance robust risk-based clinical quality programs that support our investigational products in development. This is a hands-on leadership role suited for someone who thrives in a fast-paced, dynamic environment and is excited to build and optimize quality systems from the ground up. Responsibilities
Quality Leadership & Strategy
Develop and implement a clinical quality assurance strategy aligned with company goals and regulatory expectations. Serve as the subject matter expert (SME) in GCP and clinical compliance regulations and guidelines (e.g., FDA, EMA, ICH). Provide quality oversight and guidance to cross-functional clinical teams and executive leadership.
Audit Program
Design, manage, and conduct internal and external GCP audits (e.g., site audits, vendor audits, TMF audits). Oversee audit findings, CAPA development, and follow-up to ensure timely resolution. Collaborate with CROs, vendors, and clinical sites to ensure quality expectations are met.
Inspection Readiness
Lead clinical inspection readiness activities for regulatory agency inspections. Serve as the CQA representative during inspections, ensuring timely and accurate responses.
SOP & Quality System Development
Establish and maintain GCP-related SOPs, policies, and quality management systems. Ensure continuous improvement of quality systems, procedures, and training programs.
Training & Compliance
Provide GCP training and ongoing education to clinical and cross-functional staff. Monitor compliance metrics and identify trends and areas for improvement.
Collaboration & Communication
Act as the liaison between QA and clinical operations, regulatory affairs, and senior leadership. Partner with external stakeholders (e.g., CROs, vendors) to ensure alignment on quality standards.
Qualifications
Preferred: BA/BSc in a scientific field with a minimum of 15 years’ experience; or MBA or MSc with a minimum of 10 years’ experience Preferred: 15 years of progressive responsibility in Quality Assurance in the Biotechnology industry with at least 10 years’ experience in a management or leadership role. Preferred: Recognized subject matter expert in GCP, GVP, and GCLP and clinical quality systems Preferred: Demonstrated ability to drive change within organizations. Skills
Demonstrated expert knowledge of FDA regulations, and ICH GCP guidelines. Familiarity with EMA and MHRA regulations Fast learner, adaptable, with enterprise viewpoint and excellent cross-collaboration and inter-personal skills. Experience managing audits and supporting regulatory inspections Strong knowledge of clinical trial processes, oncology and/or cell therapy a plus Ability to work independently and collaboratively among cross-functional teams. Ability to work efficiently, prioritize workflow, meet deadlines and balance competing priorities Education
BA/BSc in a scientific field; MBA or MSc (preferred or relevant)
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