Quality Assurance Manager (Remote)

Company: Trial Runners
Location: Raleigh
Posted on: January 17, 2020

Job Description:

JOB TITLE: Quality Assurance (QA) Manager DEPARTMENT : Business Operations INDUSTRY : Pharmaceutical-clinical side, not manufacturing. - **Must have experience working in the CRO/Pharma industry** Working within the Business Operations Department, the Quality Assurance Manager mentors and facilitates an efficient and effective quality group by managing processes and systems within the framework of the company's mission statement, policy, and philosophy. This role will ensure planning, coordination, control, and continuous improvement of processes and methods are established to control the quality of the studies and procedures at Trial Runners using approved tools, design control, and system validations. - The QA Manager will work closely with Clinical Operations, IT, and other areas to help ensure active participation in continuous quality improvement activities. Additionally, this position will be responsible for implementing clinical compliance plans, including GCP audits of clinical service providers, suppliers, and investigator sites, and internal audits of trial master files, and clinical and pharmacovigilance processes and procedures. RESPONSIBILITIES: Promotes an environment for continuous improvement within the organization and providing updates on regulatory trends in the industry. Responsible for Quality Assurance metrics and goals, reporting as necessary to ensure ongoing improvement and success. Lead the continuous compliance and improvement of Trial Runners' Quality Management System in accordance with company policies, industry regulations, and sponsor requirements. Write, review, and coordinate the development of SOPs and WINs Manage the CQA audit program for TR projects, including coordination of project allocation and ensuring all project assessments, audit schedules, and plans are completed and cover areas of high risk. - Conduct GCP external and internal audits to assess compliance with regulatory requirements and investigational sites. - Communicate audit findings to stakeholders and with auditees to develop CAPAs. Perform quality reviews and provide input into clinical and non-clinical documents to ensure compliance with Company SOPs and regulatory requirements. Lead and /manage inspection readiness activities and ensure project teams are trained and prepared for regulatory inspections and sponsor audits. Review, assess, and monitor regulatory inspection/sponsor audit commitments and CAPA plans for robustness and timely completion. Support the company's training program by conducting GCP training and participating in the onboarding of new employees. - Serve as a quality ambassador to the clinical team for a positive quality culture impact Responsible for TMF/eTMF Provide feedback for performance evaluation, competency/skill and career development for direct reports. - Provide input on a strategic level for the overall betterment of the company Participate in SOP Committee POSITION REQUIREMENTS: Demonstrated leadership and mentoring skills. Demonstrated ability to maintain confidentiality and the ability to multi-task and prioritize Demonstrated strong self-management skills Proficient knowledge in Clinical Research, Management, and Strategy Excellent attention to detail and accuracy Excellent prioritization and organizational skills Excellent interpersonal communication skills and works effectively on cross-functional teams Excellent verbal and written communication skills, ability to lead cross-functional teams and independently prioritize work, manage multiple projects while maintaining quality and being an advocate for regulatory compliance. Demonstrated knowledge of United States Code of Federal Regulations, ICH Guidelines and other local government regulatory requirements governing clinical research EDUCATION REQUIREMENTS: Bachelor's Degree in Life Sciences related field, or significant relevant work experience required. Masters Degree-preferred. - Minimum of 6 years in the clinical research field or high-level leadership positions that demonstrate qualification NOTE : This job description is not intended to be all-inclusive. The employee may perform other related duties as assigned to meet the ongoing needs delegated by the company.

Keywords: Trial Runners, Raleigh , Quality Assurance Manager (Remote), Executive , Raleigh, North Carolina