Senior Manager, Process Compliance Review and Analysis

Job description

Job Overview: It is the responsibility of the post holder to provide all clients, both internal and external, with the appropriate quality of service in a safe and cost-effective manner. The individual will be expected to comply with the legal requirements of the Health & Safety at Work Act 1974, the COSHH regulations 1989 and the EC (European Commission) Directives 1992/3 as documented in the Company’s Health & Safety Manual. Summary of Responsibilities: • Responsible for instituting and implementing a Quality process across designated PV and safety writing engagements. • Accountable for quality, CAPA and compliance related deliverables for the assigned PV and Safety writing engagements. • Drive implementation of best practices and process improvement for the assigned projects. • Responsible for driving quality culture for the assigned projects. • Drive CAPA management and audit readiness across projects. • Identify quality trends and suggest corrective actions. • Implement a feedback process and track implementation of feedback. • Function as a Point of Contact for the delivery team for regulatory updates, quality assurance concepts, applicable procedures, practices, and conventions on the assigned projects. • Act as the process and quality expert for the Client. • Initiate and support initiatives for standardization of quality processes and process excellence across projects within the practice. • Perform Analysis of data and if required, suggest strategies for process improvement/excellence. • Perform and Review of analysis of data performed and drive strategies for process improvement/excellence Responsible for Driving Proactive Quality processes across the project. • Oversee all aspects of quality reviews, metrics, analysis, outcomes, actions across the projects. • Support internal audits of PV/ Safety writing projects as per the audit calendar and support as required for general systems and process audits. • Oversee and conduct process reviews to ensure regulatory and client requirements and implement process improvements. • Work with delivery head & SME to develop, implement Quality Management Plan, provide inputs to Quality Agreements, Training Plans, and monitor Quality SLAs for all designated projects. • Assume accountability of supporting the client during regulatory inspections and ensuring quality and timely completion of inspection requests. • Ensure implementation of Quality Management Plan and/or the Quality Agreement for assigned projects. • Support Computer System Validation related activities as required. • Perform a critical role to ensure organization wide inspection readiness at all times. • Develop general or client-specific PV SOPs and WIs. • Assess client conventions and provide inputs on their relevance to regulatory requirements. • Assist delivery teams to identify training needs based on quality review findings. • Identify process improvements and support delivery teams in the implementation. • Support practice head in developing process framework, new offerings, and customized solutions for clients. • Assist practice head in ensuring that training material & training plans are reviewed and updated on an ongoing basis, and in conducting training sessions. • Support business development at practice level by contributing to RFP responses, proposals, and client presentations. • All other duties as needed or assigned. Qualifications(Minimum Required): • Bachelors/Masters/PhD degree in Medicine or Alternative medicine, Medical Science, Pharmaceutical science, Nursing, Life Sciences, or related area. • Fortrea may consider relevant and equivalent experience in lieu of educational requirements. Experience (Minimum Required): • 15 +years of experience in the pharmaceutical industry, biotechnology, or CRO industry primarily in Pharmacovigilance / Safety writing with experience in Quality, leading quality, and process improvements across several Safety projects. • Knowledge of regulatory requirements viz. GPV and applicable EU and FDA guidelines. • In-depth understanding of single case processing, assessment, and safety writing. • Understanding of Lean and Six sigma methodologies. • Technical proficiency with Microsoft Office suite of applications. • Understanding ofsystem validations. Preferred Qualifications Include: • Experience in assessing quality of a case/safety report from a medical, scientific and documentation perspective; experience in trending, identification of gaps & training needs is preferred. Learn more about our EEO & Accommodations request here .