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

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.

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 departments are aligned. With department leadership, partcipates in discussions regarding transformational strategies to ensure document control processes support broader business objectives, while also prioritizing and addressing urgent or critical issues as they arise.
• Administrative Tasks: Responsible for administrative activities including, but not limited to, determining document storage requirements, and overseeing the secure destruction of documents when necessary. Audits internal processes to ensure accuracy, completeness, and adherence to quality standards, ensuring document control activities are thoroughly documented and compliant with both internal and external requirements.
• Supervision and Management: Primary resonsibility for supervising staff, including assigning tasks, answering questions, making decisions and resolving issues to ensure smooth daily operations. Monitors and plans flow of work to ensure adequate materials and resources to meet productivity, quality and service expectations. Manages department schedules to ensure goals are achieved; responsible for approving time off, overtime and timekeeping reporting. Creates a culture of accountability, teamwork, and continuous improvement. Carries out performance management and development activities, including onboarding, training, setting expectations, and providing meaningful feedback. Maintains regular and transparent communications through effective use of one-on-one meetings, team meetings and other forms of formal and informal communications. Procatively manages employee relations issues; uses judgement in consulting with department leadership and Human Resources. Recommends staffing decisions to ensure a high performing team; including interviewing, selecting, training and developing staff. Ensurces compliance with Human Resources and other company policies and legal requirements, as well as Quality System and Envionmental Health & Safety (EHS), requirements. Reflects Company Values and serves as a role model to staff and customers.

Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions.

Networking/Key Relationships

• Quality Teams (Quality Assurance, Quality Engineering, Quality Production Support)
• Regulatory Team
• Manufacturing Teams
• Operations and Supply Chain Teams
• Marketing Teams
• Human Resources and Legal
• Research and Development Teams
• Werfen Manufacturing Sites and Affiliates

Minimum Knowledge & Experience required for the position:
Education:

• Bachelor’s degree in Quality Management, Engineering, Life Sciences, Business Administration, or related discipline required.
• Additional training in Document Control highly preferred (e.g., courses/seminars in Engineering Change Control and Engineering Change Requests, Document Lifecycle Management)

Experience:

• At least 5 years of experience in document control, quality management, or related field within the medical device, pharmaceutical, or biotech industries required.
• At least 3 years of supervisory experience required, in document control highly preferred, demonstrating the ability to supervise teams and comply with administrative policies.

Management has the discretion of substituting relevant work experience for a degree and/or making exceptions to the years of experience requirement.

Skills & Capabilities

• Strong understanding of regulatory requirements such as 21 CFR Part 820, ISO 13485, ISO 15223, ISO 20417, ISO 18113, and IVDR - Language requirements for manufacturers.
• Proficiency in document control software and tools, including experience with electronic Document Management Systems (eDMS), SAP (for COs, Material Master, document storage), and general office software (e.g., Microsoft Word, Excel, PDFs, EasyLabel, Codesoft, Automated Labeling System).
• Experience in drafting, updating, and managing SOPs, COs, training records, product item masters, and labeling in a regulatory context.
• Familiarity with industry standards for document control, including document formatting, naming conventions, and lifecycle management.
• Basic business acumen, including understanding of employment law, administrative policy compliance, expense management and business communications.
• Demonstrated ability to supervise operations and direct reports, with a focus on building high-performing teams and fostering a culture of accountability and continuous improvement.
• Project management experience, with the ability to participate in and/or lead projects, prioritize tasks, and work efficiently under pressure to meet deadlines.
• Experience in process improvement and risk management, including the identification of gaps and bottlenecks, implementation of corrective actions, and development of processes to enhance document control efficiency and accuracy.

Strong communication skills, with the ability to articulate complex issues clearly to both technical and non-technical audiences, and to collaborate effectively with cross-functional teams and management.

Travel Requrements:
No travel required.

Salary: $70K-$110K

If you are interested in constantly learning and being challenged on a daily basis we encourage you to submit your resume or CV. Salary range $70K-$110K.

Werfen is an Equal Opportunity employer and is committed to a diverse workplace. Werfen strictly prohibits unlawful discrimination, harassment or retaliation based upon an individual’s race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other protected characteristic as defined by applicable state or federal law. If you have a disability and need an accommodation in relation to the online application process, please contact NAtalentacquisition@werfen.com for assistance.

We operate directly in over 30 countries, and in more than 100 territories through distributors. Annual revenue is approximately $2 billion and more than 7,000 employees around the world comprise our Werfen team.

www.werfen.com