BACKGROUND

RESPONSIBILITIES

• Management of a group of 5-6 employees, responsible for management of GCP issues, including investigations and responsible for development, tracking and follow-up of CAPA responses to audits and inspections
• Supporting on a daily basis Global Clinical Research (GCR), Global Clinical Operations (GCO), Early Clinical Research and Experimental Medicine (ECREM) and Global Medical Affairs (GMA) and associated functions where necessary to facilitate the provision of clinical trial operational quality measures in relation to compliance and quality assurance
• Provide guidance and support to those tasked with supporting the development of Quality Management Systems, SOPs and training materials
• Organizing, tracking and ensuring adequate and timely reporting of investigations of GCP non-compliance issues
• Organizing and conducting the GCP Compliance Committee meetings and reporting of conclusions.
• Reporting of significant issue alerts and GCP Compliance Committee conclusions to the Quality Council
• Managing CAPA commitments to ensure quality and timely completion of CAPA deliverables.
• Support Global Inspection Organization (GIO) and clinical audit groups (GCA, GQAC) to facilitate overall readiness and responsiveness of clinical trial teams for inspections and internal and external audits.

REQUIREMENTS

• BA/BS in the life sciences
• Suitable candidate should hold a BA/BS in a science-related field. Master's Degree or higher (Ph.D., PharmD, MD) preferred.
• Must have 10 years in the pharmaceutical/ medical device/ diagnostics industry, with solid compliance experience, with at least 6-8 years experience in a supervisory role.
• Must have excellent knowledge of GCPs and cGMPs, including interpretation and application of FDA regulations. In addition, a strong understanding of international regulatory environments (e.g., EU Clinical Trials Directive / ICH / WHO), and experience working with overseas facilities, is desirable.
• Ability to recruit high-performing professionals and manage for effective performance.
• Ability to lead, coach and develop wide spectrum of skill levels, including professionals with advanced degrees
• Must have knowledge of SIP (or other process improvement methodology) and associated tools.
• Must have excellent project management and organizational skills.
• Ability to influence and drive change in compliance culture, globally.
• Must have good interpersonal skills and very strong communication skills, both written and oral.