Quality Management Systems and Regulatory Affairs Manager

7 days ago

Bedford, Bedford, United Kingdom Werfen Full time

Overview

Werfen

Werfen is a leading global company in the specialized diagnostics industry, with a strong presence in Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant. Our innovative approach and commitment to quality have enabled us to become a worldwide leader in our field. With a global footprint of over 30 countries and a workforce of more than 7,000 employees, we are dedicated to providing healthcare professionals with the most valuable and complete solutions to improve hospital efficiency and enhance patient care.

Job Summary

The Global Quality Assurance and Regulatory Affairs Systems Manager is a key role within our organization, responsible for providing leadership and strategic direction to develop and implement a cost-effective electronic Quality Management Systems (eQMS) and harmonized QA/RA information systems. This position requires collaboration with QA/RA partners, IT teams, and external vendors to design and implement efficient processes and workflows, ensuring continuity and successful delivery of functional services to users throughout the organization.

Responsibilities

  • Develop and implement a global strategy for the overall eQMS platforms, ensuring alignment with business objectives and regulatory requirements.
  • Leverage synergies between processes and workflows in different Technology Centers, promoting standardization and harmonization to optimize system performance.
  • Lead the Digital Board QARA meetings from the QA/RA perspective, ensuring effective communication and collaboration with stakeholders.
  • Conduct and participate in the analysis of workflows and design of functionality and/or improvements to systems, ensuring both process and system requirements are fully identified, evaluated, tested, and implemented.
  • Identify opportunities for process improvement, automation, application operational efficiency, and security, and implement solutions to address these areas.
  • Identify and troubleshoot system issues, working with IT, partners, and vendors to resolve these issues in a timely manner.
  • Work cross-functionally to understand business needs and provide actionable insights for ongoing stakeholders, ensuring effective communication and collaboration.
  • Work with leadership at various Werfen Technology Centers to ensure timely implementation and delivery of new functionality and enhancements.
  • Work with stakeholders within QARA at Werfen Technology Centers to create, update, and oversee processes and workflows for eQMS systems, implementing timely updates as changes occur.
  • Assist with data analytics and reporting capabilities, ensuring systems are optimized to reduce manual reporting and improve data-driven decision-making.
  • Drive the definition of business rules for platform governance, processes, and procedures, ensuring alignment with regulatory requirements and business objectives.
  • Manage eQMS supplier relationships, ensuring effective collaboration and communication to meet business needs.
  • Create and execute a strategy to ensure that local eQMS stakeholders are trained and equipped to use the system effectively.

Networking/Key relationships

  • Corporate QA/RA Team
  • Digital Board QA/RA Team
  • IT Leads and teams
  • Global Systems Analyst
  • QA/RA leadership at Werfen Technology Centers and teams
  • Key stakeholders across the organization

Qualifications

Minimum Knowledge & Experience required for the position:

  • Bachelor's degree preferably in STEM, Information Systems, or Business
  • Minimum of 5 years of directly related experience with implementing and maintaining enterprise eQMS platforms
  • Minimum of 5 years of directly related experience with QMS
  • Additional Skills/Knowledge: IT Systems Project Management, Language: English (fluent), Spanish (basic)

Skills & Capabilities:

  • Well-developed leadership skills
  • Strong verbal and written communication skills, with the ability to present complex information in an easily consumable manner
  • Ability to build relationships within Werfen departments
  • Work cross-functionally to understand business needs and provide actionable insights for ongoing stakeholders
  • Robust organizational skills
  • Excellent time management skills, with proven ability to meet deadlines
  • Strong analytical and problem-solving skills
  • Advanced understanding of database construction and configuration
  • Good computer skills and proficiency with QA/RA systems
  • Ability to effectively champion the project to completion through constant interaction with peers and senior leadership in a professional manner
  • Ability to evaluate issues and new requirements to assess impact to the product and/or business
  • Ability to accept and act on constructive criticism
  • Demonstrates negotiation skills for conflict resolution
  • Be a high-energy and results-oriented individual who is mature and successful in a business environment and is skilled in motivating and inspiring people

Travel requirements:

  • Up to 25% travel, domestic and international

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