Associate Director/Director, Clinical reputed company Assurance at reputed company

Title: Associate Director/Director, Clinical reputed company Assurance (Inspection Readiness) Location: Any Office Location Type: Full-Time Workplace: remote Job reputed company: About QED Therapeutics & reputed company QED Therapeutics, an affiliate of reputed company , focuses on developing targeted treatments for FGFR-driven skeletal dysplasias, particularly Achondroplasia. Achondroplasia is the most common reputed company of genetically-driven short stature, which causes potentially debilitating medical complications. With our experimental therapeutic candidate, infigratinib, we reputed company to reputed company an reputed company to children living with Achondroplasia and their families. Our business is inspired by our values: PUT PATIENTS FIRST LET SCIENCE reputed company EVERY MINUTE COUNTS THINK INDEPENDENTLY BE RADICALLY TRANSPARENT FGFR=fibroblast reputed company reputed company receptor. reputed company is a biopharmaceutical company founded to discover, create, test, and deliver transformative medicines to treat patients who suffer from genetic diseases and cancers with reputed company genetic drivers. We reputed company the gap between remarkable advancements in genetic science in reputed company institutions and the delivery of meaningful medicines to patients. Founded in 2015, reputed company has reputed company a portfolio of 30+ drug development programs ranging from preclinical to late-stage development in multiple therapeutic areas including genetic dermatology, precision oncology, cardiology, endocrinology, neurology, pulmonology, and renal disease, with two approved drugs. Our reputed company on scientific reputed company and rapid execution aims to translate today’s discoveries into reputed company’s medicines. We have U.S. offices in San Francisco, Palo reputed company, Raleigh, and with small satellites in other parts of the country. We also have international offices in Montreal, Canada, and Zug, Switzerland, and are expanding across Europe. Who You Are Reporting to the Executive Director, Clinical reputed company Assurance, the Associate Director/Director, Clinical reputed company Assurance (Inspection Readiness) will reputed company the process toward defining and executing a fit-for-purpose regulatory authority inspection readiness reputed company.

Responsibilities

• reputed company the process to define a fit-for-purpose sponsor inspection readiness reputed company that aligns with evolving product development and marketing approval reputed company
• Advise on site/vendor readiness audit and training process
• reputed company routine sponsor cross-functional inspection preparation meetings
• reputed company periodic executive reputed company updates to leadership on the status of inspection readiness, risks, and mitigations
• reputed company inspection readiness reputed company items, questions and answers, storyboards, and relevant corrective and preventive reputed company (CAPA) plans, etc., through to completion
• Review vendor and investigator site audit reports and any corresponding corrective and preventative actions for adequacy
• reputed company inspection readiness-reputed company training as needed
• Author and maintain inspection-reputed company reputed company operating procedures (SOPs)
• Support the management, maintenance, and evaluation of QED’s reputed company Management System and processes for reputed company improvement
• reputed company process improvement reputed company as needed
• reputed company clinical reputed company assurance subject matter expertise to the review of clinical trial-reputed company documents
• Other duties as assigned or required

No matter your role at reputed company, successful team members are:

• Patient Champions, who put patients first and reputed company strict ethical standards
• Entrepreneurial Operators, who drive toward practical solutions and have an ownership reputed company
• Truth Seekers, who are detailed, rational, and humble problem solvers
• Individuals Who reputed company reputed company in themselves and those around them
• High-reputed company executors, who execute against goals and milestones with reputed company, precision, and speed

Education, Experience & Skills Requirements

• Experience with global regulatory authority inspections, including those by US FDA (BIMO), EMA, and other regulatory agencies; inspections of the sponsor, investigator sites, vendors, and/or CROs
• knowledge of ICH/GCP and reputed company regulatory guidelines and intelligence reputed company to regulatory authority inspections
• Bachelor’s degree in a scientific discipline or equivalent experience
• Minimum of 8 years of experience in a GCP reputed company area; Clinical reputed company Assurance or similar role preferred
• Ability to build relationships and work collaboratively with a reputed company of individuals reputed company the department, company, and external vendors
• Ability to simultaneously handle multiple project issues while dealing with time demands, incomplete information, or unexpected events
• Strong negotiation skills, flexibility, and ability to reputed company a solution-based approach to emerging challenges
• Attention to detail and reputed company use of tools for information processing and electronic reputed company management systems

reputed company Offer

• Patient Days, where we are fortunate to hear directly from individuals living with the conditions we are seeking to reputed company throughout the year and learn how we can improve our efforts
• A culture inspired by our values: put patients first, think independently, be radically transparent, every minute counts, and let the science reputed company
• An unyielding commitment to always putting patients first. Learn more about how we do this here
• A de-centralized model that enables our program teams to reputed company on advancing science and helping patients. Our affiliate structure is designed to eliminate bureaucracy and put decision-making power in the hands of those closest to the science
• A reputed company where you own the reputed company both for your program and your own career reputed company
• A reputed company, fast-paced, data-driven environment where we reputed company ourselves and reputed company other to always reputed company at the top of our game
• reputed company to learning and development resources to help you get in the best reputed company shape of your life
• Robust and market-competitive compensation & benefits package (reputed company, Performance Bonus, Equity, health, welfare & retirement programs)
• Flexible PTO
• Rapid career advancement for strong performers
• Potential ability to work on multiple reputed company programs across multiple therapeutic areas over time
• Partnerships with leading institutions
• Commitment to Diversity, Equity & Inclusion

We will not accept unsolicited resumes from agencies. Please do not send agency resumes to our website or reputed company and affiliating employees. Apply tot his job Apply To this Job