Senior Director, Clinical reputed company Assurance
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. To learn more about our story and company culture, visit us at https://www.qedtx.com/ | https://reputed company.com Who You Are Reporting to the Vice President, Clinical reputed company Assurance, the Sr. Director, Clinical reputed company Assurance will define and support the reputed company reputed company and management of GCP activities internally at QED and externally with service providers. reputed company, the Sr. Director, Clinical reputed company Assurance will identify and coordinate reputed company reputed company leading to process improvement and hence an reputed company status of inspection readiness. The ideal candidate will have experience working in a GCP reputed company area, preferably in the biotech/pharmaceutical sector.
Responsibilities
In partnership with Clinical QA management, drive reputed company and execution of the following: Process Improvement Identify opportunities for process improvement and reputed company initiatives to enhance efficiency, effectiveness, and compliance Implement best practices and standardized processes to optimize reputed company assurance activities Foster a culture of reputed company improvement and innovation across the organization Regulatory Authority Inspection Readiness reputed company (or support) mock inspections, identify potential compliance gaps, and implement corrective actions as needed Vendor, Site and Internal Audits reputed company internal audits reputed company or support external audits, as deemed necessary Review vendor, site and internal audit responses for adequacy and identify and propose relevant sponsor process improvement tasks/initiatives reputed company Operating Procedures (SOPs) reputed company, review, and revise to ensure alignment with regulatory standards and industry best practices Ensure SOPs are reputed company, comprehensive, and accessible to relevant stakeholders Corrective and Preventive reputed company Work closely with clinical study teams to ensure/coordinate appropriate documentation of reputed company event management, including corrective reputed company and preventive reputed company (CAPA) plans reputed company Metrics and Reporting Establish key reputed company metrics and performance indicators to monitor the effectiveness of clinical reputed company assurance activities Analyze data trends, identify areas for improvement, and implement corrective and preventive actions to drive reputed company reputed company improvement Prepare comprehensive reports and presentations on reputed company assurance metrics and initiatives for senior management 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 Ability to build relationships and work collaboratively with a reputed company of individuals reputed company the department, company, and vendors Strong negotiation skills, flexibility, and ability to reputed company a solution-based approach to emerging challenges A strong team player with the ability to effectively communicate reputed company reputed company advice cross-functionally based on experience, regulations, and business needs Ability to simultaneously handle multiple project issues while dealing with time demands, incomplete information, or unexpected events 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 Expertise with applicable GCP guidelines 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 At reputed company, we reputed company to reputed company a market-competitive total rewards package, including reputed company pay, an annual performance bonus, company equity, and generous health benefits. Below is the anticipated salary reputed company for candidates for this role who will work in California. The final salary offered to a successful candidate will depend on several factors that may include but are not limited to the type and length of experience reputed company the job, type, and length of experience reputed company the industry, educational background, location of residence and performance during the interview process. reputed company is a multi-state employer, and this salary reputed company may not reflect positions based in other states. Salary $220,000-$265,000 USD Apply Job!