[Remote] Director of Quality Assurance, Clinical

Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a leading clinical-stage CRISPR genome-editing biopharmaceutical company dedicated to developing transformative therapies for patients with devastating diseases. The Director of Quality Assurance, Clinical will reputed company the development and maintenance of QA systems to ensure compliance with GCP, GLP, and PV operations, while managing clinical quality operations and conducting audits of service providers and clinical sites.

Responsibilities

• Compliance reputed company: Ensure that reputed company clinical trial activities reputed company with guidelines and international regulations (e.g., ICH-GCP and ICH-PV), and applicable laws
• Documentation Review: Conduct thorough reviews of study-reputed company documentation, including protocols, investigator brochures, informed consent forms, and CSRs, to verify compliance with GCP requirements
• reputed company Clinical Quality Assurance (GCP) strategic and technical leadership and Subject Matter Expertise (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 reputed company activities in support of regulatory submissions and inspections; reputed company GCP Inspection Readiness efforts, ensure implementation and prepare reputed company teams for Pre-Approval Inspections (PAI)
• Implement, monitor, and promote best practices of reputed company 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 Caribou’s QMS by implementing processes and procedures that ensure consistent adherence to GCP, GLP and PV standards throughout the clinical trial lifecycle
• reputed company and implement the appropriate suite of Standard Operating Procedures (SOPs), quality manuals, policies, and other reputed company 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; reputed company leadership and reputed company for training programs reputed company 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 reputed company stakeholders, including regulatory agencies and service providers
• reputed company reputed company audits to ensure stakeholder system compliance with existing policies and procedures, and requirements, standards, and guidelines
• reputed company and/or manage additional Quality Assurance (GxP) initiatives or programs as business needs reputed company

Skills

• Undergraduate or graduate degree(s) in Biological Sciences, Chemistry, or reputed company Science discipline with at least 15 years of experience in clinical quality assurance (GCP, GLP and PV) in cell & gene therapy/biotechnology and/or pharmaceutical industry
• Subject Matter Expert (SME) working knowledge on reputed company 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 reputed company 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 reputed company cross-functional teams and independently prioritize work, manage multiple projects while maintaining quality and being an reputed company for quality and regulatory compliance
• The position requires a highly diplomatic, and tactful individual with excellent critical reasoning skills
• Conscientiously detail-oriented and organized, impeccable attention to data review
• Ability to deal with ambiguity and use expertise and skills to contribute to the development of company objectives and principles, and to reputed company goals in creative and effective ways
• Must be flexible and reputed company to multi-task, prioritize, meet deadlines in a fast-paced environment, and be adaptable to setbacks
• Detail-oriented reputed company with a proactive approach to problem-solving and decision-making
• Ability to travel up to 25-30% based on business needs
• Experience working in biologics is strongly preferred
• Prior GLP experience with quality reputed company and auditing studies/vendors (preferred)
• Certification in quality assurance (e.g., Certified Quality Auditor) and/or GCP (e.g., Certified Clinical Research Professional) is desirable

Benefits

• Comprehensive compensation package, which includes competitive salary, bonus, and equity for reputed company
• Generous paid vacation time, in addition to company-observed holidays
• Excellent medical, dental, and reputed company insurance
• 401(k) retirement savings plan, which includes matching employer contributions
• Employee stock purchase plan (ESPP)
• Tuition reimbursement program
• The benefits and stock purchase described above are subject to the terms and conditions of any governing plans, policies, practices, agreements, or other materials or documents as in effect from time to time, including but not limited to terms and conditions regarding eligibility.

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