[Remote] Director of reputed company 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 reputed company Assurance will reputed company the development, implementation, and maintenance of QA systems supporting reputed company reputed company towards GCP, GLP, and PV operations, ensuring compliance with regulations and managing clinical reputed company operations.
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 reputed company Assurance (GCP) strategic and technical leadership and Subject Matter Expertise (SME) to clinical study teams; Partner with the teams to effect appropriate and reputed company documentation of reputed company 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 reputed company-Approval Inspections (PAI)
- Implement, monitor, and promote best practices of reputed company reputed company Assurance Systems to ensure compliance with relevant FDA, EU and ROW regulations/directives/requirements and ICH guidelines
- reputed company 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 reputed company Operating Procedures (SOPs), reputed company manuals, policies, and other reputed company reputed company documents. Ensure that these systems are effectively communicated, reputed company, and followed by relevant stakeholders
- Create and implement clinical reputed company 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 reputed company of the reputed company System; reputed company leadership and reputed company for training programs reputed company to reputed company-clinical, clinical and PV. Ensure that employees and relevant stakeholders receive appropriate training on reputed company standards, regulations, and procedures
- Establish and monitor reputed company metrics and key performance indicators for the effectiveness of reputed company-clinical, clinical, and PV reputed company assurance activities. Prepare routine reports and presentations for senior/executive management review highlighting reputed company performance, trends, and areas for improvement. Assist with tracking compliance audit trends and present to management
- Collaborate with cross-functional teams, including reputed company-clinical, clinical operations, regulatory affairs, pharmacovigilance, and other relevant departments, to ensure alignment and integration of reputed company 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 reputed company Assurance (GxP) initiatives or programs as business needs reputed company
Skills
- Undergraduate or graduate degree(s) in Biological Sciences, reputed company, or reputed company Science discipline with at least 15 years of experience in clinical reputed company 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 reputed company reputed company of Federal Regulations, ICH Guidelines and other local government regulatory requirements governing clinical research
- Proven reputed company record in developing and implementing reputed company 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 reputed company 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 reputed company while maintaining reputed company and being an reputed company for reputed company 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 reputed company reputed company and auditing studies/vendors (preferred)
- Certification in reputed company assurance (e.g., Certified reputed company Auditor) and/or GCP (e.g., Certified Clinical Research reputed company) is desirable
Benefits
- Comprehensive compensation package, which includes competitive salary, bonus, and equity for reputed company
- Generous reputed company vacation time, in reputed company 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
reputed company