Director, Quality Improvement Salary at Caminar BETA

Job Description Job Description Role Description Reporting directly to the CSO, the Director of Quality Assurance (QA) is responsible for establishing and administering quality systems supporting compliant nonclinical laboratory study Good Laboratory Practice (GLP) and or phases thereof and testing activities producing primary or secondary endpoints of clinical studies Good Clinical Laboratory Practice (GCLP). Assure Test Site Management (TSM) that facilities, equipment, personnel, methods, practices, records, and controls are in conformance of regulations. Key Responsibilities Host client and regulatory inspections including preparing responses of findings thereof. Supports organization regulatory professionals across BABM sites. Assure GLP protocol requirements are met by auditing phase specific raw data, data summary tables, draft and final phase reports associated with nonclinical studies or bioanalytical sample analysis protocols to evaluate regulatory compliance. Establish and ma

Corcept is leading the way in the research and development of cortisol modulators, molecules that regulate cortisol activity at the glucocorticoid receptor (GR). To date, we have discovered more than 1,000 selective proprietary cortisol modulators. In 2012, we received FDA approval of Korlym® (mifepristone), the first approved treatment for hypercortisolism (Cushing's syndrome). Today, our team and collaborators continue to unlock the possibilities of cortisol modulation as a way to treat serious diseases. With more than 30 ongoing studies across a wide range of disease areas, including endocrinology, oncology, metabolism, and neurology, we remain dedicated to advancing the possibilities of cortisol modulation. What began as a ripple of scientific truth is now poised to unleash a sea change of discovery representing a fundamental shift in the way we understand and treat disease. The Director Pharmacovigilance Quality Assurance is a senior member of the CQA team. The Director will lead

Director, Quality Assurance Overview of Role: The Director of Quality Assurance will lead the quality activities at Summit during clinical development and commercialization of drug candidates. Responsible for deviation resolutions, investigations, CAPAs, change controls batch record review, and development of robust quality systems. The Director of Quality Assurance will provide QA support in the preparation of quality sections of regulatory submissions. Role and Responsibilities: * Develop and implement GMP quality systems including all quality policies and procedures pertaining to GMP manufacture and testing in accordance with ICH, FDA, EMA and other global health authority regulations and industry standards * Responsible for providing sponsor oversight of Contract Manufacturing Organizations (CMO) to support clinical and commercial manufacture. * Provide GXP compliance oversight for all vendors and CMOs and provide on-site oversight of CMO operations as needed * Lead and ensure GMP

Who Are We? Our company is based on the science of our founder, Stanley Qi, one of the original CRISPR co-inventors who then furthered the technology so that DNA does not need to be cut to accomplish gene regulation. Instead, we regulate the epigenome to suppress and activate multiple genes simultaneously. We are further evolving the platform and leveraging its strengths to address unmet medical needs. We are looking for exceptional team members who want an active role in building a rapidly growing biotech. Epicrispr Biotechnologies is seeking a highly motivated Director/Sr. Director (Head) of Quality Assurance. This position requires ambition, adaptability, and a team-oriented mindset, but also a strong ability to organize parallel projects and work independently to develop a strong quality infrastructure. Position Summary The Director/Senior Director of Quality will oversee all quality aspects of the organization from Quality Assurance to Quality Control. The ideal candidate will def

Revolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies to inhibit high-value frontier targets in RAS-addicted cancers. The company's R&D pipeline comprises RAS(ON) Inhibitors designed to suppress diverse oncogenic variants of RAS proteins, and RAS Companion Inhibitors for use in combination treatment strategies. As a new member of the Revolution Medicines team, you will join other outstanding scientists in a tireless commitment to patients with cancers harboring mutations in the RAS signaling pathway. Revolution Medicines is seeking an Associate Director, Clinical Quality Assurance, who will play a key role within Quality Assurance and is responsible for providing leadership and compliance support for RevMed sponsored clinical trials with respect to RevMed's Standard Operating Procedures, applicable regulatory requirements (FDA, EU, ICH & country-specific), and current industry standards and practices. The Opportunity: Support

Alumis Inc. is a precision medicines company with the mission to transform the lives of patients with autoimmune diseases. Even with treatment innovations of the last two decades, many patients with immunologic conditions continue to suffer - our goal is to fundamentally change the outcomes for these patients. Alumis is hiring a Clinical Quality Assurance Sr. Director, reporting to the SVP of Quality. The role will work closely with the Development leadership and Study Execution Team members to provide GCP/GVP support for all ongoing clinical studies. This involves working closely with Clinical Operations, Clinical Development, Clinical Supply Chain, Medical Affairs, Regulatory, Legal, and other teams across Alumis. The Clinical QA Sr. Director is responsible to ensure quality is embedded throughout the lifecycle of all the ongoing clinical programs through oversight, assessment and monitoring, risk assessment tools and risk mitigations. The Sr. Director will be responsible to establis

Job Description Title: Associate Director, Analytical Quality Assurance Location: Brisbane, CA About Us: Vera Therapeutics (Nasdaq: VERA), is a late-stage biotechnology company focused on developing treatments for serious immunological diseases. Vera's mission is to advance treatments that target the source of immunologic diseases in order to change the standard of care for patients. Vera's lead product candidate is atacicept, a fully humanized fusion protein self-administered at home as a subcutaneous injection once weekly that blocks both B-cell Activating Factor (BAFF) and A Proliferation Inducing Ligand (APRIL), which stimulate B cells and plasma cells to produce galactose-deficient IgA1 (Gd-IgA1) and associated autoantibodies, which together form immune complexes that are fundamental in the pathogenesis of IgA nephropathy (IgAN). Vera is also considering evaluating the role of atacicept in other immunologic disorders. Additionally, Vera is developing MAU868, a monoclonal antibody

About the job Associate Director, Clinical Quality Assurance Job Title: Associate Director, Clinical Quality Assurance Job Location: United States Job Location Type: Remote Job Contract Type: Full-time Job Seniority Level: Mid-Senior level Attention recruitment agencies: All agency inquiries are vetted through 4DMT's internal Talent Acquisition team. No unsolicited resumes will be accepted. The 4DMT Talent Acquisition team must expressly engage agencies on any requisition. Agencies contacting hiring managers directly will not be tolerated, and doing so may impact your ability to work with 4DMT in the future. 4DMT is a clinical-stage biotherapeutics company harnessing the power of directed evolution for targeted genetic medicines. We seek to unlock the full potential of gene therapy using our platform, Therapeutic Vector Evolution (TVE), which combines the power of directed evolution with our approximately one billion synthetic AAV capsid-derived sequences to invent evolved vectors for