Global Compliance & Performance Senior Associate

​Research & Development​

The Global Compliance Quality Team manages the quality performance of Reckitt, also providing oversight of the Quality Management System (QMS) and Quality compliance programmes. The team provide quality metrics KPI and insights for the end-to-end supply model (Factories, EMOs and Commercial Teams), utilising the metrics data to drive continuous quality improvement and compliance efficiency, also using coaching and influencing skills to ensure quality issues are effectively addressed and preventative actions are suitably embedded.  In addition, the team provides support and leadership of key strategic compliance continuous quality improvement projects (QIPs).

The team supports the Reckitt group to ensure Factories, Commercial Units and External Manufacturing Quality groups remain compliant with regulatory requirements for the countries of manufacture and sale, via compliance with Reckitt QMS and internal standards.  They will partner factories and commercial units in the preparation for, hosting of and completion of responses to international GMP audits, also use risk-based methods to generate and manage the Reckitt Cross audit plans.

To achieve this role holder will (both directly and indirectly through influencing others): 

•    To support in driving the compliance agenda across all sites, EMO, DC and Commercial Units; partnering with Region and Supply Leads. 
•    To support the network of Compliance Teams in gathering, report and analysing Factory, Commercial units, and EMO group Key Quality Metrics.
•    To lead collation of weekly, monthly, and quarterly quality reporting, ensuring continuous improvement of content and format, based on feedback and business requirements.
•    To work closely with the quality leads to track progress of the actions from GRIs and significant quality issues to ensure actions are closed out as committed. 
•    To support Hygienic Design network with KPIs, and support with implementation of Global hygiene design initiatives. 
•    To support, deploy and monitor the global initiatives like 6-to-fix priority projects.
•    To lead selected quality improvement projects as identified by the Global Reckitt Supply / Quality teams.
•    To prepare monthly performance review for Reckitt Supply and Quality Leadership Teams, including KPIs and GRI trends, and progress of key initiatives.
•    To collate and monitor compliance data across Reckitt, analysing data to propose Global action plans.
•    Support and deputise for the Global Quality Compliance and Performance Senior Manager.

About the role

Scope:
Reporting to the Global Quality Compliance and Performance Manager, the primary scope of the role is:

• Operating as part of the Reckitt Global Quality Compliance & Performance team.
• Support the Reckitt factories, Commercial Units and External Manufacturing Quality groups with metrics collation and facilitate the cascade of the Global metrics, for input into the Total Reckitt.
• Lead, support and coach factories, commercial units and EMO groups with Compliance and Quality Improvement activities.
• Develop and deliver training across Global Reckitt, along with routine coaching of best practices in areas such as root cause problem solving, CAPA generation and quality risk management.
• Supporting the factories, Commercial Units and EMO Quality groups to be at a constant state of audit readiness, ensuring procedures are kept up to date with current business and regulatory expectation, and in line with Global Reckitt QMS.
• Assists with the collation of the necessary Reckitt post market surveillance activities in support of the Global Medical devices ISO certification.

Accountability:
• On time delivery of monthly collation of Global KPIs on behalf of Global Reckitt Director, including input into the Cross-business metrics Core Reckitt, Essential Home and MJN.
• Analysis of KPI data to provide recommendation to the Reckitt on key priorities for resolution, or potential emerging compliance risks.
• Generation of relevant weekly, monthly, and quarterly quality reporting; ensuring continuous improvement of content, based on feedback and business requirements.
• Lead and support Quality improvement projects for the Reckitt.
• Lead and guide factories with the completion of the Self-Assessment Standards and implement processes and targets which support the achievement of quality standards; accurately presenting findings and leading the thinking to ensure appropriate actions are driven at a site level.
• Makes recommendations and leads actions to improve process, procedures and systems with respect to the Global Reckitt QMS, and in support of Factory QMS; ensuring where possible that key learnings and requirements are captured Globally.
• Develops and maintains personal expertise in key areas such as relevant legislation and GMP guidelines. This will be achieved through a systematic and recorded CPD process (continuous professional development).

Your responsibilities

Key Challenges:
• Reporting KPIs within timeframes given and chasing up any discrepancies with sites, commercial units and EMO groups to ensure all metrics are correctly reported.
• Support and implement the vision to automate Compliance data and improve overall process efficiency. 
• Effectively prioritise workload based on risk and business benefit. 
• Ability for International travel and flexibility with working hours due to the time zones of the associated Heath factories.
• Audit readiness - Minimise regulatory adverse comment with regards the Reckitt Factories.
• Supporting the Global Quality Compliance and Performance Senior Manager in influencing the Factories and External manufacture Quality Management groups to maintain compliance with regulations and Reckitt standards whilst communicating key learnings within the group to drive improvement.
• Leading or supporting various quality improvement projects within the Reckitt Supply group.
• Coach best practices across the Reckitt supply group.

Technical / professional qualifications required: 
• Educated to degree level
• Good understanding of Reckitt factory operations, QC testing operations and quality management systems.
• Broad understanding of Reckitt manufacturing operations business. 
• Skilled in collation and reporting of performance metrics, including analysis of data and storytelling
• Knowledge of the legal requirements, rules and guidance covering the manufacture of pharmaceutical products, medical devices, cosmetics, food and general product in Europe (preferred).  
• Experience in a manufacturing environment. 

The experience we're looking for

• At least 5 years of experience working in a quality and or regulatory compliance function in a Reckitt, Pharmaceutical, or Medical Device related FMCG industry.
• Experience in developing and maintaining a robust QMS.  
• Good understanding of typical regulatory requirements relevant to a regulated product e.g. EU GMP, WHO, PIC/S, CFR 21 Part 111/ 210/ 211/ 820, ISO stds 13485 + 22716, etc.. Plus others.
• Good working knowledge of Industrial Pharmaceutical Microbiology and Hygienic Design requirements
• Strong communication skills 
• Well-developed influencing skills.  Diplomatic and tactful in challenging situations.
• Highly motivated and able to self-manage time and workload.
• Organised and able to deliver concise written or oral summaries to senior management.
• Capable of linking data sources together and translating to drive business improvement. Including PowerBI proficiency in Excel & PowerBI and other software used to analyse data.
• High attention to detail.
• Problem-solving aptitude and experience in use of root cause problem solving tools.