Global QA/ra Systems Manager - Bedford, United States - Werfen

Werfen

Verified Company

Bedford, United States

2 weeks ago

Posted by:

Mark Lane

beBee recruiter

Description

Job Overview:

Post Date

May 15, 202

Number
ICIMS
Job Function
QA&RA
Location
Bedford 180 Hartwell Road Bedford, Massachusetts 01730 United States
Country
United States
Shift
1st

About the Position:

Overview:

Werfen
Werfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain.

We are a worldwide leader in specialized diagnostics in the areas of Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant.

Through our Original Equipment Manufacturing (OEM) business line, we research, develop, and manufacture customized assays and biomaterials. We operate directly in 30 countries, and in more than 100 territories through distributors.

Our Headquarters and Technology Centers are located in the US and Europe, and our workforce is more than 7,000 strong.

Our success comes from a specific focus in these rapidly evolving diagnostic areas, our commitment to customers, and our dedication to innovation and quality.

We're passionate about providing healthcare professionals the most valuable and complete solutions to improve hospital efficiency and enhance patient care.

Job Summary

Reporting to the Corporate VP QA/RA, the Global QA/RA Systems Manager is responsible for providing leadership, planning, project coordination, and management to develop a cost-effective electronic Quality Management Systems (eQMS) and harmonized QA/RA information systems while concurrently facilitating efficient operations to meet current and future business needs.

Responsible for collaborating with QA/RA partners within Werfen Technology Centers and, various departments (e.g, IT), and outside vendors to develop efficient and effective processes and workflows as well as analyzing and directing all functionally related activities within the scope of the eQMS.

This position is accountable for ensuring continuity and successful delivery of functional services to users throughout the organization.

Responsibilities:

Key Accountabilities

Development of al global strategy, implementation, maintenance, operations, and optimization of the overall eQMS platforms.
Leverage synergies between processes and workflows in the different Technology Centers and promote standardization/harmonization to the extent possible.
Lead the Digital Board QARA meetings from the QA/RA side.
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 and troubleshoot system issues and work with others (IT, partners, vendors) as needed to bring to resolution.
Work crossfunctionally to understand business needs and provide actionable insights for ongoing stakeholders needs.
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 and implement timely updates as changes occur.
Assist with data analytics and reporting capabilities, ensuring systems are optimized to reduce manual reporting.
Drive definition of business rules for platform governance, processes and procedures.
Manage the eQMS supplier relationships.
Create and execute a strategy to ensure that local eQMS stakeholders are trained.

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:

Welldeveloped leadership skills
Strong verbal and written communication skills. Ability to present complex information in an easily consumable manner
Ability to build relationships within Werfen departments
Work crossfunctionally to understand business needs and provide actionable insights for ongoing stakeholders needs
Robust organizational skills
Excellent time management skills with proven ability to meet deadlines
Strong analytical and problemsolving 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