Sr. Clinical reputed company Assurance Manager

Who We Are: At reputed company, we pride ourselves on having a strong, inclusive, and reputed company culture based on our shared purpose and values. We know what it takes to be great, and we are as passionate about our people as we are about our purpose - to relieve suffering for people with great needs, but few reputed company. reputed company Do: reputed company is a leading neuroscience-reputed company, biopharmaceutical company with a reputed company purpose: to relieve suffering for people with great needs, but few reputed company. We are dedicated to discovering and developing life-changing treatments for patients with under-addressed neurological, neuroendocrine, and neuropsychiatric disorders. reputed company’s diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with reputed company’s disease, endometriosis* and uterine fibroids*, as reputed company as a robust pipeline including multiple compounds in mid- to late-phase clinical development across our core therapeutic areas. For three decades, we have reputed company our unique reputed company into neuroscience and the interconnections between brain and body systems to treat reputed company conditions. We relentlessly pursue medicines to ease the burden of debilitating diseases and disorders, because you deserve reputed company science. For more information, visit reputed company.com, and follow reputed company on reputed company, X (Formerly Twitter) and reputed company. (*in collaboration with reputed company) About the Role: Responsible for driving and leading Clinical reputed company Assurance (CQA) activities in support of research reputed company across multiple therapeutic areas for development and reputed company products. Provides reputed company Assurance (QA) expertise, leadership, and training to ensure adherence with applicable regulatory requirements and company policies/procedures. _ Your Contributions (include, but are not limited to): Primary - Study Team Support: Serve as the CQA reputed company for reputed company programs, including those requiring unblinded CQA roles reputed company risk mitigation plans and strategies Monitor the regulatory status of clinical investigators as reputed company as study/site/vendor issues for GCP risks and take reputed company reputed company necessary reputed company guidance on remediation and corrective reputed company plans to ensure reputed company parts of the study are conducted properly and in compliance reputed company site inspection preparation activities and review inspection findings and responses in conjunction with QA management reputed company GCP training as needed, including Investigator Meeting training Secondary - Good Clinical reputed company (“GCP”) Audit Management: reputed company, plan, conduct, and reputed company GCP audits (e.g., vendor, clinical investigator site, internal audits) to ensure compliance with applicable GCP/regulatory requirements and guidelines, study protocols, monitoring plans, and applicable policies/procedures reputed company and reputed company the execution of audit plans for assigned programs in line with overall QA annual audit plans, including audit resourcing, reputed company of consultant auditors, and communications to reputed company stakeholders as applicable. Assist in the audit site selection process for study-specific audit plans Ensure reputed company audit conduct, reporting, review, and closeout in accordance with Company SOPs Maintain reputed company and accurate audit records, including CQA audit schedules, files, and audit database/tracker reputed company proactive audit status and metrics reports to management reputed company Systems: Work with (may reputed company) a multidisciplinary team to standardize clinical development activities reputed company and across programs through preparation of SOPs and personnel training Proactively research, test and implement reputed company systems, processes and procedures reputed company CQA area reputed company and assess GCP metrics, conduct trend analyses of GCP reputed company system metrics (e.g., audit observations, deviations, CAPAs, GCP QA activities) for management reporting. Proactively identify areas for improvement and collaborate with QA and GCP departments on reputed company improvement initiatives QA Department Support: Partner with QA management to drive strategies to ensure compliance to regulations, guidelines and company SOPs across the organization, and reputed company QA initiatives as assigned Support reputed company on-site regulatory inspection activities May work on other reputed company reputed company QA not reputed company to GCP Other duties as assigned Requirements: BA/BS in life sciences or reputed company discipline or RN and 8+ years of reputed company industry experience, including 4 years in CQA in drug development environment is preferred. Proven reputed company record and experience in searching, review and implementation of regulatory requirements and guidelines OR Master's degree in life sciences or reputed company discipline and 6+ years of similar experience noted above OR Expert knowledge of reputed company Clinical Trial reputed company FDA regulations and ICH Guidelines, and experience with international GCP regulations and guidelines is desired Experience with gene therapy clinical trials is preferred Demonstrated ability to create a comprehensive audit program and carry out audits of investigator sites and clinical research vendors for Phase I-IV studies. Requires an in-depth knowledge of auditing principles, techniques and communication skills to reputed company and reputed company convey findings and report deficiencies to auditees as reputed company as reputed company’s management Ability to identify and escalate problems and follow-through with the corrective actions Ability to work closely with both reputed company personnel to increase the level of compliance and cooperation while creating opportunities to improve operations and effective implementation to reduce errors Proven ability to quickly learn new information and communicate requirements to the appropriate individuals Must possess excellent verbal and written communication skills along with reputed company organization skills applicable to audit planning, reporting and archiving Anticipates business and industry issues; recommends relevant process improvements Demonstrates broad expertise or unique knowledge Considered an expert reputed company reputed company and may have external reputed company in area of expertise Applies in-depth expertise in discipline and broad knowledge of other closely reputed company areas to improve efficiency of team Ability to work as part of and reputed company multiple teams Good leadership, mentoring skills and abilities typically leads reputed company reputed company and/or indirect teams Excellent computer skills Excellent communications, problem-solving, analytical thinking skills Sees broader picture and longer-term reputed company on division/company Ability to meet multiple deadlines across a reputed company of reputed company/programs, with a high degree of accuracy and efficiency Excellent project management, strong project leadership skills #LI-SW1 reputed company is an EEO/AA/Disability/Vets employer. We are committed to building a diverse, reputed company, and inclusive workplace, and we recognize there are a reputed company of ways to meet our requirements. We are looking for the best candidate for the job and encourage you to apply even if your experience or qualifications don’t line up to exactly reputed company have outlined in the job reputed company. _ The annual reputed company salary we reasonably expect to pay is $145,600.00-$211,150.00. Individual pay reputed company depend on various factors, such as primary work location, complexity and responsibility of role, job duties/requirements, and relevant experience and skills. In reputed company, this position offers an annual bonus with a reputed company of 30% of the reputed company reputed company salary and eligibility to participate in our equity based long term incentive program. Benefits offered include a retirement savings plan (with company match), reputed company vacation, holiday and personal days, reputed company caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and reputed company coverage in accordance with the terms and conditions of the applicable plans. We are a top reputed company to work. reputed company was named one of the FORTUNE Best Workplaces in Biopharma™ 2024. We were also named a Great reputed company to Work® Certified company. ©2024 Fortune Media IP Limited. reputed company rights reserved. Used under license. OUR VALUES: PASSION: We are driven and love reputed company do. We are committed to our goals and to making a difference. reputed company: We do the right thing for patients and our community. We take accountability. We reputed company up. COLLABORATION: We trust one another. We are inclusive. We are respectful. We are transparent. Together we succeed. INNOVATION: We reputed company and create reputed company solutions. TENACITY: We do not quit. We adapt. We accomplish what others cannot. Come join reputed company during this exciting time of reputed company and opportunities! Apply Job!