Job Description

Contact: Anne Marie Fox
Email: recruit@hero.ie
Telephone: 087 2197421

Complaints Project Manager & Business Analyst

Our client, a medical device company in Galway is currently looking to recruit a Complaints Project Manager & Business Analyst for their site.

Responsibilities and Duties

Lead the Project to deploy the Complaints Intake process and the change initiatives to integrate, leverage and implement AQR Policies and Processes
Identify, plan and implement the project scope (including changes), ensuing risk, issues, and dependencies are understood, communicated and baselined, whilst any assumptions are verified
Utilize the ARDx project management methodology (MAPS), and coaching project team members in its use
Create and resource a project team to ensure successful project delivery. Take an active part in steering groups to ensure that project oversight and governance is in place and effective
Ensure the project meets the expectations of Quality and Regulatory compliance guidelines and satisfy FDA, ISO, internal and respective market & regulatory requirements
Make sure the Salesforce.com electronic system is assessed, and plans put in place to maintain its validated state
Create a step-change improvement in the operational effectiveness (i.e. procedures, work instructions, etc.) of the Business Unit and centralized hubs by driving the deployment of the project
Work with Business Unit and centralized hub leaders to plan the future project roadmap and budgets on a rolling basis. Define new projects and their resource implications; challenging team members to ensure they fit into their priorities
Work with the Quality and Regulatory Excellence program leader to report progress against plan, risks, issues, dependencies, overall delivery and financial status
Develop a close working relationship with the Business Unit leaders to understand the requirements, and to inform their decision making with respect to the Complaints Intake Process
Document requirements, translate requirements into high level complaints management processes and business solutions, verify & validate the solutions, deploy the solution and measure its effectiveness
Maintain knowledge of strategic developments within the Business Unit and in the diagnostics / medical devices industry at large ensuring at all times that the project has relevant content to support the strategic and competitive direction of the Business Unit
Embed continuous improvement strategies into the project discipline whilst operating a controlled, structured and well managed project
Any other duties reasonably requested to meet business objectives

General Responsibilities

Pro-active self-starter, with a hands-on, practical approach and the determination, commitment and flexibility to meet the demands of the position
Strong customer service orientation, able to understand, manage and meet the project demands, and deliver exceptional service to the Business Unit, complaints intake hubs and colleagues at all times
Seen as a role model, as well as a reputable representative for the Complaints Intake team
Solid team skills, able to effectively motivate cross functional, virtual teams, and lead or delegate as required to ensure achievement of team and project objectives
Proficient communicator in English with excellent written and verbal communication skills, strong influencing and persuasion skills, and ability to instill confidence in others
Results oriented mind-set, with excellent analytical skills, methodical and logical approach, and the ability to combine technical knowledge, judgment skills on a pragmatic approach
Outstanding time management abilities, diligent and conscientious approach, able to work under pressure, organize and prioritize a busy workload, and adapt to fit the changing needs of the Business Unit
Must be diplomatic, persuasive and able to handle difficult conversations with colleagues from varying backgrounds and cultures
Carries out duties in compliance with established practices, Policies and Processes
Demonstrates commitment to the development, implementation and effectiveness of the Business Unit Quality Management System per ISO, FDA, and other regulatory agencies
Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the Complaints Intake team and is consistent with the Complaints Management Policies and Processes
Understands and is aware of the quality consequences which may occur from the improper performance of their role

Qualifications/Requirements
Essential

Fluent business English speaker
Prince2 Practitioner qualification (or equivalent in PMP, IPMA or CAPM)
Bachelor’s Degree or equivalent qualification (as a minimum)
Experience (i.e. greater than 3 end-to-end projects) of successfully managing Quality & Regulatory projects, with demonstrable evidence of effective design, delivery and problem-solving skills
Proven track record of delivering projects in complaints management and/or establishing quality management systems (internally and/or externally)
Project team management experience leading a team greater than 5 FTEs, with a mix of internal and contractor team members, spread across multiple time zones
Working knowledge of US FDA 21 CFR Part 11 and EU Annex 11
Supplier qualification and management experience
Strong technology awareness (i.e. Oracle Agile PLM, ensur, SalesForce.com and SharePoint)
Experienced in the application of Software Development Life Cycle (SDLC) methodologies and software change management.
Demonstrated experience as a Business or Systems Analyst, including process modelling

Desirable

ASQ or AAMI certification
Experience of leading and implementing change initiatives and active stakeholder management
Experience of working with culturally diverse groups of people, able to communicate effectively at all levels of the business, and with both technical and non-technical people, adapting approach to suit the audience
Experience of establishing and leading teams, and coaching and developing team members to maximize individual and team effectiveness
Experience as a System Administrator and/or configuration expert for Salesforce.com
Additional languages (Continental European or East Asian preferred)

For further information on this Complaints Project Manager & Business Analyst role in Galway please contact Anne Marie Fox on 087 2197421 / recruit@hero.ie

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