Senior Manager, Process Compliance Review and Analysis

Job Overview:
It is the responsibility of the post holder to provide all clients both internal and external with theappropriate quality of service in a safe and cost-effective manner. The individual will be expected tocomply with the legal requirements of the Health & Safety at Work Act 1974 the COSHH regulations1989 and the EC (European Commission) Directives 1992/3 as documented in the Companys Health &Safety Manual.

Summary of Responsibilities:
Responsible for instituting and implementing a Quality process across designated PV andsafety writing engagements.
Accountable for quality CAPA and compliance related deliverables for the assigned PV andSafety 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 assuranceconcepts 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 excellenceacross 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 processimprovement/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 asrequired for general systems and process audits.
Oversee and conduct process reviews to ensure regulatory and client requirements andimplement 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 designatedprojects.
Assume accountability of supporting the client during regulatory inspections and ensuringquality and timely completion of inspection requests.
Ensure implementation of Quality Management Plan and/or the Quality Agreement forassigned 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 customizedsolutions for clients.
Assist practice head in ensuring that training material & training plans are reviewed andupdated on an ongoing basis and in conducting training sessions.
Support business development at practice level by contributing to RFP responses proposalsand 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):
10 years of experience in the pharmaceutical industry biotechnology or CRO industry
primarily in Pharmacovigilance / Safety writing with experience in Quality leading quality andprocess 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 anddocumentation perspective; experience in trending identification of gaps & training needs is preferred.

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