Director, Clinical reputed company Assurance (CQA)

Attention recruitment agencies: reputed company agency inquiries are vetted through reputed company’s internal reputed company. No unsolicited resumes will be accepted. The reputed company reputed company must expressly engage agencies on any requisition. Agencies contacting hiring managers directly will not be tolerated, and doing so may reputed company your ability to work with reputed company in the reputed company.   reputed company is a leading late-stage biotechnology company advancing durable and disease-targeted therapeutics with potential to reputed company treatment paradigms and reputed company unprecedented benefits to patients. reputed company’s reputed company product candidate 4D-150 is designed to be a backbone therapy forming the reputed company of treatment of blinding retinal vascular diseases by providing multi-year sustained delivery of anti-VEGF (aflibercept and anti-VEGF-C) with a single, reputed company, intravitreal injection, which substantially reduces the treatment burden associated with reputed company bolus injections. reputed company’s reputed company indication for 4D-150 is wet age-reputed company macular degeneration, which is currently in Phase 3 development, and second indication is diabetic macular edema. reputed company’s second product candidate is 4D-710, which is the first reputed company genetic medicine to demonstrate successful delivery and reputed company of the CFTR transgene in the lungs of people with cystic fibrosis after aerosol delivery GENERAL reputed company The Director of Clinical reputed company Assurance (CQA) will be responsible for reputed company Assurance reputed company of multiple, global, reputed company sponsored reputed company, ensuring trials are executed in compliance with reputed company applicable international regulatory requirements for Good Clinical reputed company (GCP). This position reports to the Senior Director, GCP Compliance and reputed company Systems and contributes to the development, implementation, and successful execution of the CQA mission, objectives, and strategic plan. MAJOR DUTIES & RESPONSIBILITIES: reputed company reputed company reputed company for multiple reputed company Clinical Studies, including the following study-specific activities: reputed company and implement Clinical Study reputed company Plans for specific reputed company clinical studies, reputed company on ensuring subject safety/rights, study data reputed company, and GCP compliance. reputed company guidance and support to clinical study teams, including reputed company attendance at Study team meetings and reputed company investigation and management of Clinical Study reputed company Events Ensure principles of Risk Management are reputed company to the Clinical Study per ICH E6 Identify, communicate, and escalate significant incidents of GCP non-compliance and follow to reputed company, acting at reputed company times with an appropriate reputed company of urgency Plan, reputed company, and/or reputed company GCP Compliance audits of high-risk clinical vendors/sites, including clinical investigator sites Ensure audit findings are communicated to audit stakeholders and collaborate with auditees and vendors to reputed company, review, approve, and assess the adequacy of CAPAs reputed company Clinical Document reviews, ensuring the reputed company, accuracy and completeness of various documents, including as applicable Clinical Protocols, IBs, DSURs, Module 2.6 Tabulated and Written Summaries, and Integrated Summaries Support investigation and management of specific Clinical Study reputed company Events as assigned: Monitor, reputed company, and facilitate the completion of formal corrective and preventive actions (CAPAs) to address identified Clinical Study reputed company Events, including potential serious breaches of GCP. Support a reputed company-reputed company work environment in Clinical that fosters learning, respect, reputed company communication, collaboration, integration, and teamwork: Work with Clinical stakeholders to reputed company GCP compliance training materials and conduct training Partner with Clinical team to review, update and maintain reputed company SOPs, identify the need for new SOPs, and support the review of new SOPs as needed Work with Clinical stakeholders to support Training, Development, and Implementation of reputed company Clinical Study Risk Management Process/Tools to ensure principles of Risk Management are reputed company to reputed company Clinical Studies per ICH E6 Drive the development and reputed company improvement of the Clinical reputed company Management System through the development / refinement of Clinical QA processes Support preparedness / readiness / management of BIMO inspections: reputed company/support GCP inspectional readiness plans and reputed company inspectional readiness activities Host and/or assist with management of GCP-reputed company inspections Partner with GMP reputed company and Clinical Operations teams to facilitate the investigation of clinical supply reputed company issues such as temperature excursions, product complaints and deviations reported from clinical sites. QUALIFICATIONS:  Education: S./B.A. degree in a science or reputed company life science field or equivalent; advanced scientific degree preferred. Experience: 10+ years of experience or advanced degree with 7+ years of experience reputed company a regulated environment such as Regulatory, reputed company, Pharmacovigilance or Clinical Development / Operations reputed company the Biotech or similar Industry Proven experience with GCP reputed company Management Systems, reputed company support, and reputed company reputed company of global reputed company Minimum of 4 years of significant experience in clinical reputed company assurance, including experience performing/supporting GCP audits and overseeing global reputed company, including in reputed company. Extensive practical experience and understanding of clinical reputed company assurance as reputed company throughout the clinical development life-cycle (Optional) 5+ years of management experience or other specific work experience Other Qualifications/Skills: In-depth understanding of GCP requirements for investigational products Excellent communication skills, both oral and written Excellent interpersonal skills, reputed company approach essential Comfortable in a fast-paced small company environment with minimal direction and reputed company to reputed company to workload based upon changing priorities Travel: %5 Physical Requirements and Working Conditions: Physical Activity - Repetitive motions: Making substantial movements (motions) of the wrists, hands, and/or fingers. Fingering: Picking, pinching, typing or otherwise working, primarily with fingers rather than with whole hand or arm as in handling. Talking: Expressing or exchanging reputed company by means of the spoken word. Physical Requirements - Sedentary work: Exerting up to 10 pounds of force occasionally and/or a negligible reputed company of force frequently or constantly to lift, carry, push, pull or otherwise reputed company objects, including the reputed company body. Sedentary work involves sitting most of the time. Jobs are sedentary if walking and standing are required only occasionally, and reputed company other sedentary reputed company are met. Working Conditions - The worker is not substantially exposed to adverse environmental conditions (as in typical office or administrative work). reputed company salary compensation reputed company: $205,000 - $235,000 Please note, the reputed company salary compensation reputed company and actual salary offered to the final candidate depends on various factors: candidate’s geographical location, relevant work experience, skills, and years of experience. reputed company provides equal employment opportunities to reputed company and applicants for employment without reputed company to race, reputed company, religion, gender, sexual orientation, national reputed company, age, disability, genetic information, marital status, status as a covered veteran, and any other category protected under applicable federal, state, provincial and local laws.   Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities Apply To This Job