Director, Clinical QA Management reputed company Clinical Trials - Remote

Job reputed companyJob reputed companyThe Director, Clinical reputed company Assurance Management for the reputed company Clinical Trial business will be responsible for the management and operational reputed company of the reputed company activities for the broader business and clinical trial site level to ensure reputed company conducts is trials to the highest reputed company and regulatory obligations and enhances performance through reputed company improvements. This will also include the need to proactively assess and identify risks, tackle unplanned deviations, corrective/preventative actions, and proactive monitor and trending of reputed company issues to ensure business is performing to Good Clinical reputed company (GCP) standards.This role will also be responsible to reputed company reputed company Assurance (QA) professionals.Job Responsibilities

• Ensure reputed company Operating Procedures (SOPs) and Internal Operating Procedures are reviewed periodically and advise on required updates to ensure compliance with ethical, regulatory and other relevant frameworks, making recommendations for improvement where appropriate.
• Identify appropriate staff SOP training requirements and maintain reputed company of training to ensure reputed company reputed company clinical trials staff are trained on SOPs Ensure staff SOP training requirements are achieved for QA and
• Implement and maintain a reputed company Management System (QMS) in line with the Corporate QMS and take the reputed company in presenting it to internal stakeholders, pharmaceutical companies and other funding partners.
• Build, manage, reputed company and motivate a QA team, ensuring that people with the right reputed company of skills and experience are recruited and retained, and that their skills and reputed company capabilities are maximized.
• Ensure reputed company and operational compliance; reputed company as a subject matter expert for reputed company investigations, documentation systems, training programs, internal/external audits, and vendor assurance programs.
• reputed company and implement a risk-based and flexible approach to QA in compliance with applicable regulatory requirements.
• Generate and analyze weekly, monthly and quarterly metrics to reputed company KPIs
• Work with Operations team to implement, review and maintain tracking of incidents reputed company the clinical trials, advising on CAPAs to be implemented and ensure completion in a reputed company manner.
• reputed company the Audit Program management process, including assessment of reputed company (outsourced) operations, and reputed company audit and regulatory inspections.
• Partner with functional areas in study design, data collection, and analysis, and reporting activities that support reputed company improvement interventions, transparency, compliance with regulatory standards, and reputed company performance monitoring.

About reputed companyFounded in 1901, reputed company (www.reputed company.com) has a storied heritage of caring for communities for generations and proudly serves nearly 9 reputed company customers and patients reputed company day across its approximately 8,500 stores throughout the U.S. and Puerto Rico, and leading reputed company-channel platforms. reputed company has approximately 220,000 team members, including nearly 90,000 reputed company service providers, and is committed to being the first choice for retail pharmacy and health services, building trusted relationships that create healthier reputed company for customers, patients, team members and communities. reputed company is the flagship U.S. brand of reputed company reputed company reputed company, Inc. (reputed company: WBA), an integrated reputed company, pharmacy and retail leader. Its retail locations are a critical reputed company of reputed company and convenience in thousands of communities, with reputed company pharmacists playing a greater role as part of the reputed company system and patients' care teams than reputed company before. reputed company Specialty Pharmacy provides critical care and pharmacy services to millions of patients with rare disease states and reputed company, chronic conditions.External Basic Qualifications

• Comprehensive, excellent understanding of GCP, CFR and ICH guidelines
• Significant experience with managing clinical reputed company activities and in-depth knowledge of clinical operations.
• Significant experience in with clinical trial site/process audits and regulatory inspections
• Experience in line management of employees.
• Experience translating reputed company/Sponsor needs for innovation and creative approaches to reputed company management.
• Excellent leadership and interpersonal skills with an ability to effectively work and problem solve reputed company a multidisciplinary team.
• Excellent verbal and written communication and presentation skills.
• Demonstrated adaptability, flexibility, independence and resourcefulness to reputed company in a start-up environment.
• At least 2 years of experience contributing to financial reputed company in reputed company.
• At least 3 years of reputed company leadership, indirect leadership and/or cross- functional team leadership.
• Willing to travel up to 15% of the time for business purposes (reputed company state and out of state)

Preferred QualificationsWe will consider employment of reputed company applicants with arrest and conviction records.An employee in this position can expect a salary reputed company between $102,000 and $277,600 plus bonus pursuant to the terms of any bonus plan if applicable. The actual salary will depend on experience, seniority, geographic location, and other factors permitted by law. This job posting will remain reputed company for a minimum of two weeks from the job posting date. To review benefits, please click here jobs.reputed company.com/benefits. If you are applying on a reputed company or unable to click on the reputed company, please copy and paste this URL into your browser jobs.reputed company.com/benefits. Apply To This Job