Job Description

• Works closely with Quality & Medical Governance colleagues and Business Functions to provide expert input management of issues and support for continuous improvement
• Collaborate and provide input into internal and external audit programs which support GxP compliance.
• Supports the proactive identification and management of GxP risks
• Support deviation identification, reporting, and CAPA development
• Undertakes effective compliance reporting to Quality and Medical Governance senior management and cross functional leadership
• Leads Medical Affairs quality governance forum and provides input to other quality forums as required.
• Monitors changes in industry/regulatory environment that would necessitate future changes and proactively initiates discussions to prepare the company to respond to such changes.
• May lead/support management of regulatory inspection activities such as readiness preparation, inspection host/co-host, and/or provision of input into responses to inspection reports.
• Contributes to establishing and reviewing quality standards and procedures and represents Quality and Medical Governance in cross functional Working Groups as required.
• Handle multiple projects and consider a number of factors in planning and prioritising work to meet tight timelines.

Required Knowledge, Skills, and Abilities

In order to apply for the Senior Compliance Manager, Quality & Medical Governance contract, you should possess extensive experience in GxP within the pharmaceutical industry and have a highly developed knowledge of regulatory requirements. You should possess strong verbal and written communication skills and interpersonal skills and be proficient with Microsoft office suite and have experience with audit management / CAPA management programs. Excellent organisational skills and project management skills are a must.