Due to continued expansion of my clients operations, we are looking for a Senior Business Process Analyst with Regulatory Project Control experience for a global transformation program.
As a Senior Business Process Analyst, you will play a key role in ensuring the successful Business Transformation working on process relating to regulatory product controls. This is a key role, reporting to Snr Manager Product Owner- Product Controls, collaborating with Workstreams, Process Owners, Community of Practices and Stakeholders across the network.
This role represents the Regulatory business Users, collaborating with Workstreams, Strategic Integration Vendors, COP teams and Stakeholders across the network. The Program will have the following phases: Requirements Gathering, Design, Build and Testing, Deployment to post Go Live sustaining.
Responsibilities
- The role represents the Regulatory and Product Control Business Users in the Agile ERP team, working closely with Stakeholders to translate User Requirements into Quality Business User Stories and the 'Who, What, Why' Acceptance Criteria.
- Coordinating and liaison with the other Workstreams, Strategic Integration Vendors, SME's, Communities of Practice's, IT Solution Architects/COE, Quality Stewards and Stakeholders across the network to develop a strong and deep pool of expertise across Quality processes and Applications.
- Liaise with the Training team and Site Super Users/SMEs to develop training plans for each of the key Applications to enhance the knowledge base across the Regulatory organization.
- Supporting a cross functional network to deliver the Transformation for regulatory product controls.
- Aligning Requirements, monitoring project plans, communicating with Stakeholders, coordinating the Requirements, Design, Build and Testing Phase and supporting the network-wide Deployment.
- Fostering an inclusive workplace that enables all participants to contribute to their full potential in pursuit of organizational and personal objectives
Requirements
- Bachelor's degree in Regulatory Affairs, Quality, Engineering, Science, Computer Science, Business or related field required.
- 3+ years technical professional or operational experience in medical device field required.
- Strong knowledge of regulatory and product control processes is preferred
- Previous experience of a major Program introduction/upgrade, ideally within an IT/Systems or Business representative role desired but not essential.
- Working knowledge of ERP, MES and PLM systems and the broader Application Ecosystem (eCERT, CAPA, GCMS, FARS, etc.), and Interfaces, combined with knowledge of key business processes.
- A proven track record of Continuous Improvement, system upgrades/enhancements or proactive problem solving.
- Previous experience of Scale Agile Project Management an advantage and/or proven adaptability, comfortable with change and with a demonstrated ability to react and response to a fast-changing environment.
Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.
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