Director/Senior Director, Clinical Quality Assurance

Director/Senior Director, Clinical Quality Assurance This range is provided by Cates Consulting. Your actual pay will be based on your skills and experience talk with your recruiter to learn more. Base pay range $200,000.00/yr - $245,000.00/yr Additional compensation types Annual Bonus and Stock options Direct message the job poster from Cates Consulting Gene Editing Biopharma located in Northern California. Position requires one day per week in office. Candidate must have significant cell, gene therapy and/or biologic experience in CLINICAL QUALITY. Position can be Director or Senior Director depending upon experience. Responsible for leading in the development, implementation and maintenance of QA systems and activities supporting quality oversight towards GCP, GLP, and PV operations. The incumbent will assist in the development of quality systems to ensure clinical trials are conducted in accordance with appropriate regulations, guidelines, procedures, and protocols. About the Role The incumbent is also responsible for developing specific internal procedures, training of staff, and hosting regulatory inspections. The position involves managing clinical quality operations and liaison of clinical quality related issues with Companys functional areas. The candidate will perform audits of service providers, study sites, and internal processes. Responsibilities Compliance Oversight: Ensure that all clinical trial activities comply with guidelines and international regulations (e.g., ICH-GCP and ICH-PV), 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. Provide Clinical Quality Assurance (GCP) strategic and technical leadership and SME to clinical study teams; Partner with the teams to effect appropriate and timely documentation of quality event management, including CAPA plans in support of product pipeline. Plan and oversee activities in support of regulatory submissions and inspections; Lead GCP Inspection Readiness efforts, ensure implementation and prepare internal and external teams for Pre-Approval Inspections (PAI). Implement, monitor, and promote best practices of all Quality Assurance Systems to ensure compliance with relevant FDA, EU and ROW regulations/directives/requirements and ICH guidelines. Quality Management System (QMS): Maintain and enhance QMS by implementing processes and procedures that ensure consistent adherence to GCP, GLP and PV standards throughout the clinical trial lifecycle. Develop and implement the appropriate suite of Standard Operating Procedures (SOPs), quality manuals, policies, and other related quality documents. Ensure that these systems are effectively communicated, understood, and followed by relevant stakeholders. Create and implement clinical quality risk management strategies to identify, assess, and mitigate risks associated with clinical development and operations. This involves conducting risk assessments, developing risk mitigation plans, and overseeing their implementation. Build training and approve curricula based on the key elements of the Quality System; Provide leadership and oversight for training programs related to pre-clinical, clinical and PV. Ensure that employees and relevant stakeholders receive appropriate training on quality standards, regulations, and procedures. Establish and monitor quality metrics and key performance indicators for the effectiveness of pre-clinical, clinical, and PV quality assurance activities. Prepare routine reports and presentations for senior/executive management review highlighting quality performance, trends, and areas for improvement. Assist with tracking compliance audit trends and present to management. Collaborate with cross-functional teams, including pre-clinical, clinical operations, regulatory affairs, pharmacovigilance, and other relevant departments, to ensure alignment and integration of quality assurance activities. Build and maintain effective relationships with internal and external stakeholders, including regulatory agencies and service providers. Qualifications Key Qualifications: Fifteen years of experience in clinical quality assurance (GCP, GLP and PV) in cell & gene therapy/biotechnology and/or pharmaceutical industry. Experience working in biologics is strongly preferred. Subject Matter Expert (SME) working knowledge on current interpretation/implementation of United States Code of Federal Regulations, ICH Guidelines and other local government regulatory requirements governing clinical research. Proven track record in developing and implementing quality systems and processes in a clinical setting. Expertise in creating and executing audit plans outlining all service providers (vendor) audits, clinical investigator site audits, CSV audits and process audits. Advanced knowledge of Quality Assurance principles, concepts, industry practices, and standards. Excellent verbal and written communication skills, ability to lead cross-functional teams and independently prioritize work, manage multiple projects while maintaining quality and being an advocate for quality and regulatory compliance. The position requires a highly diplomatic, and tactful individual with excellent critical reasoning skills. Undergraduate or graduate degree(s) in Biological Sciences, Chemistry, or related Science discipline Required Skills Preferred Skills Cell or gene therapy experience Certification in quality assurance (e.g., Certified Quality Auditor) and/or GCP (e.g., Certified Clinical Research Professional) is desirable. Seniority level Director Employment type Full-time Job function Quality Assurance Referrals increase your chances of interviewing at Cates Consulting by 2x #J-18808-Ljbffr