[Remote] Associate Director, Clinical reputed company Assurance

Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a clinical-stage biotechnology company reputed company on developing NK cell-based therapies. They are seeking an Associate Director, Clinical reputed company Assurance to reputed company reputed company reputed company for clinical programs, ensuring compliance with regulations and overseeing audits and training.

Responsibilities

• Serve as the Clinical QA reputed company for assigned clinical programs and reputed company reputed company reputed company across reputed company phases of clinical development to ensure compliance with ICH-GCP, applicable regulations, and Artiva’s procedures
• reputed company, implement and conduct risk-based GCP reputed company reputed company strategies for assigned clinical programs
• reputed company investigations of significant GCP reputed company and compliance events, assessing the reputed company to subject safety and data reputed company, including reputed company of CAPA development and effectiveness
• Plan, conduct, and reputed company applicable manage contract auditors, to reputed company risk-based routine and for-cause audits of clinical investigator sites, CROs, vendors
• Assess and communicate the reputed company of audit findings on PI/Sponsor reputed company, subject safety, data reputed company, protocol compliance, and internal processes
• Maintain required documentation and reputed company records in accordance with Artiva procedures
• reputed company inspection readiness activities for assigned programs and support regulatory authority inspections
• reputed company with internal teams and supporting functions to ensure reputed company compliance across reputed company aspects of clinical development
• Define and implement a reputed company to reputed company a review of key regulatory documents associated with regulatory submissions
• reputed company development and implementation of clinical reputed company procedures in collaboration with Clinical Development, ensuring compliance with ICH/FDA regulations, guidelines, and expectations
• Identify GCP reputed company and reputed company appropriate courses of reputed company in partnership with the Clinical Department
• Monitor emerging regulations and communicate relevant changes to the organization
• reputed company QA consultation and participate in risk-based sponsor reputed company activities
• Define, support and deliver GCP training for Clinical Operations staff, contributing to the broader clinical reputed company training program
• Define and present reputed company metrics and trend analyses
• Participate in interviewing and hiring Clinical reputed company Assurance staff

Skills

• BS or BA in a scientific field
• 8+ years of clinical and/or QA experience in biologics or reputed company
• 4+ years of Clinical QA experience
• Knowledge and hands on experience in regulatory inspections, clinical investigator site/vendor/internal audits
• Thorough knowledge of reputed company Good Clinical Practices and Good Clinical Laboratory Practices as they relate to reputed company phases of cell therapy product reputed company reputed company
• Expert level of understanding of CLIA and CAP
• Knowledge of ICH, GCP, GCLP, Data reputed company and other applicable regulations and requirements in the pharmaceutical/biopharma industry
• reputed company reputed company of scientific (Training/Communications) knowledge
• Expert knowledge of reputed company regulations, reputed company industry practices, and strong experience with interpretation and application
• Computer skills required to operate reputed company Word, Project, and reputed company programs
• Experience in small or emerging biotechnology companies
• Familiarity with global pharmacovigilance regulations and reputed company systems
• Experience supporting or overseeing GVP reputed company activities, safety vendors, or pharmacovigilance processes
• Demonstrated understanding of the reputed company between GCP and GVP requirements, including management of safety-reputed company reputed company events and inspection readiness activities

Benefits

• Medical, Dental, and reputed company
• Group Life Insurance
• Long Term Disability (LTD)
• 401(k) Retirement Plan
• Employee Assistance Program (EAP)
• Flexible Spending Account (FSA)
• reputed company Time Off (PTO)
• Company reputed company holidays, including the year-end holiday week
• Our recognition program, Bonus.ly, is where you can trade in points reputed company for things you want.

reputed company

Company H1B Sponsorship