• Bachelor's degree in related Health Science field or equivalent.
• A broad scientific/pharmaceutical industry background with relevant experience in pharmaceutical research and/or pharmacovigilance.
• Previous experience of Good Clinical Practice, Good Pharmacovigilance Practice and/or Quality Assurance is preferred.
• Knowledge of global, regional and national regulatory requirements and regulations
• Knowledge of the drug development and clinical processes
• Has demonstrated ability to manage global projects and programs, which can contain regional focus/drivers in a culturally diverse organization
• Have a demonstrated and sound working knowledge of the approach and perspectives of regulatory agencies
• Demonstrated experience interacting with regulatory agencies
• Demonstrated ability to function effectively as team member; to communicate professionally and effectively, with all levels of management and to negotiate persuasively
• Must have a high degree of organizational awareness and working towards resolution with complex problems
• Have demonstrated project management skills and management of cross-functional activities
• Have demonstrated ability for good verbal, written and presentation skills
• Ability and desire for frequent domestic and international travel (approximately 25-40%)
An advanced degree would reduce the work related experience requirement.
Provide Independent Quality Assurance to GSK R&D, by conducting independent QA assessments and assisting CDQA management in setting priorities, developing schedules, and tracking of deliverables.
Identify compliance issues, monitor trends, be accountable for driving quality improvements back into R&D Business Functions and improve processes.
Support QA activities during regulatory inspections and build solid working relationships with Risk Managers and Compliance Officers, establish a network of contacts, and maintain knowledge of local regulatory frameworks and global regulatory reporting requirements.
• Independently plan, lead, and conduct routine CDQA assessments of GSK studies, systems, external vendors and GSK Operating Companies to assure compliance with GxPs and GSK policies and procedures, and applicable local regulations
• Assist in the planning, and conduct of complex CDQA assessments
• Effectively document assessment findings in an assessment report and obtain responses in a timely fashion
• Report and present to clinical development staff, clinical investigators and contract research organization staff findings from assessments and give advice on resolving issues identified
• Generate and provide metrics, status and trend reports and other information, as required by management
• Assist CDQA Management to develop, implement and assess clinical quality assurance strategies, organizational and operational needs
• Act as a consultant and represent department to clinical development staff and teams in relation to compliance, quality improvement, business redesign initiatives and risk assessment
• Provide advice in relation to obtaining compliance, quality improvement, process and program initiatives and risk assessment and act as point of contact for customers and CDQA staff
• Maintain an up to date and in depth knowledge of appropriate national and international GxP legislation and guidelines; and the impact to assigned business area processes and procedures
• Educate, guide and influence GSK management and staff on best quality and compliance policy and practices, especially as they relate to areas of identified responsibility
• Assist in developing and maintaining customer training programmes and help deliver training within area of expertise
• Work independently and as a member of assigned CDQA team
• Build and maintain beneficial working relationships with all internal and external customers
• Lead local and international GxP and process improvement projects by providing CDQA input, especially on areas of responsibility
• Manage/Champion and participate in other projects or duties assigned by the CDQA management specific to CDQA teams accountabilities.
* LI GSK
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