Supervisor, Document Control - AID

Introduction

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.

Overview

Job Summary

The Document Control Supervisor is responsible for overseeing the daily activities of the Document Control group. Oversees all activities associated with change orders, SAP training sessions, quality plan tasks, document and record processing, metrics, artwork for labeling, and other tasks that help to achieve department objectives. Works closely with other Quality & Regulatory teams, other departments, and management to ensure activities effective operations. Resolves procedural and process issues as well as recommends ares for improvement. Manages direct reports to comply with company policies and meet department goals. This position is the subject matter expert in document control processes and procedures. Ensures all work is completed in accordance with Inova Quality Management System.

Responsibilities

Key Accountabilities

The main responsibilities of this role include:

• Regulatory Compliance & Quality Management: Maintains a strong understanding of document control requirements within Quality Management Systems (QMS) and ensures compliance with changing regulations. Includes overseeing the document lifecycle and ensuring all Change Orders (CO) meet established requirements for accurate completion and implementation. Responsible for maintaining compliance with relevant regulations and procedures. Supports and represents department during audits and regulatory inspections, collaborating with Regulatory Affairs to ensure submissions meet all requirements.
• Document Control Processes: Manages and optimizes document control processes, including efficient handling of Cos to ensure errors, inconsistencies, and delays are minimized. Drafts, updates, and trains staff on Standard Operating Procedures (SOPs) and Work Instructions (WI). Maintains expertise in SAP for document-related transactions, including those related to the Material Master. Determines appropriate document types, manages document formats, and provides administrative guidance to ensure accuracy and efficiency of document management across various platforms, including Word, Excel, and PDFs. With stakeholders, manages the creation and maintenance of document control processes related to Product Lifecycle. Overees scheduling and organizing SAP training and Quality related training plans and ensures training records are maintained. Develops, maintains and reports document control and SAP and Quality related training metrics.
• Labeling and Translation Processes: Responsible for the product labeling processes to ensure all labeling materials meet regulatory requirements and align with company branding. Collaborates with R&D, Marketing, and Regulatory Affairs to align labeling with product specifications. Provides training and guidance to team members on labeling standards and procedures. Manages timelines and deliverables for labeling requests.
• Process Improvement & Technology: Drives process improvements by promoting technological solutions, identifying bottlenecks, and implementing processes to enhance efficiency. With department management, develops and maintains an electronic document strategy, manages metrics, and may participate in or lead Quality Process Programs (QPPs) to ensure continuous improvement. Assesses current processes, implements feedback mechanisms, assess risks, and establishes disaster recovery processes to mitigate document control risks. The goal is to create a streamlined and resilient document control system that adapts to evolving business needs.
• Collaboration & Communication: Effective communication and collaboration are critical in this role. Collaborates with internal customers to understand their needs and ensure seamless processes, including other departments and Werfen Technology Centers. Communicates process changes clearly to stakeholders and provides formal training to ensure all dep