Quality Documentation Manager

Company Description

At Sobi, each person brings their unique talents to work as a team and make a difference. We are dedicated to developing and delivering innovative therapies to improve the lives of people who live with a rare disease. Our edge comes from our team of people and our commitment to patients.

Job Description

The Quality Documentation Manager is responsible for managing the lifecycle of GxP-controlled documents across the organization, ensuring that all controlled documents (e.g. policies, SOPs, work instructions, forms) are accurate, compliant and accessible. This role ensures global alignment with quality standards, internal procedures and regulatory requirements. Supporting documentation during audits and inspections, this role acts as subject matter expert (SME) for the document management system, contributing to audit readiness and operational efficiency.

Key Responsibilities/Scope of the Job

Owner of the Global Document Lifecycle Management

• Manage creation, revision, review, approval, distribution and archival of GxP controlled documents in accordance with established procedures and retention policies.
• Define Document Management KPIs for GxP and provide report of data for regular metrics and monthly KPI reporting including regular Quality Management Reviews.
• Support cross-functional teams in ensuring consistency in formatting, structure, and language across global controlled documents.
• Enforce periodic reviews and timely updates for controlled documentation.
• Manage workflows within the Electronic Document Management System (EDMS).
• Train users on system use and document best practices.
• Monitor and troubleshoot workflow issues and liaise with IT and system vendors when required.
• Business Admin for Quality Docs (EDMS):
• Manage daily tasks related to the admin responsibilities and GxP business needs

Complaince & Audit Support

• Ensure compliance with documentation standards (e.g. ALCOA+).
• As SME, prepare documentation for and participate in audits and regulatory inspections.

QMS Development and governance

• Lead the development, maintenance, and continuous improvement of an agile QMS framework to align with company strategy and Global Quality Mission.
• Support developing and deployment of the QMS aspects of Sobi’s integration strategy for companies/product acquisition and new affiliates into Sobi QMS (focus Documentation Management System).
• Change Management: oversee cross-GxP changes to the document management process through assessing impact, ensuring effective adoption of the changes across all relevant functions and affiliates.
• Risk Management: proactively identify and manage risks related to the area of responsibility within the global QMS.
• Partner with the Quality System Managers to oversee the Document Change Control process ensuring efficient and effective management of the GxP procedural documentation landscape. Training and Education · Promoting awareness of quality principles and practices across the organization.
• Contribute to the improvement of the Quality mindset across Sobi. Continuous Improvement
• Ensure that continuous improvement principles are developed and applied consistently within Sobi‘s QMS
• As an outcome of the QMR and monthly KPI meetings, identify compliance and process performance gaps within Sobi QMS.
• Lead and support continual improvement activities to ensure compliance with regulations and strengthen the performance of the QMS aiming at standardization and simplification throughout Sobi. Collaboration and Communication
• Act as the global liaison for document control practices across all GxP functions.
• Develop and deploy effective communication within the organization regarding documentation aspects.

Collaborate with GPOs:

• Supporting Inspection readiness related to documentation management.
• Providing guidance and support to identify and close regulatory compliance gaps related to documentation across the global and local GxP areas.
• Keep GPOs up to date regarding changes in the documentation management process.

Qualifications

Education/Learning Experience/Work Experience

• Minimum 5 years’ experience in pharmaceutical industry preferably within Quality System, Manufacturing, R&D, with 3+ years experience in EDMS.
• Bachelor's degree in Life Sciences, Chemistry, Pharmacy, Regulatory Affairs, or a related field (preferred).

Skills/Knowledge/Languages

• Experience in Quality System, specifically in Documentation Management, Quality Processes or Quality Management System.
• Experience in writing procedural documents.
• Experience with EDMS, documentation related KPIs.
• Experience in working in an international organisation.
• Fluent in English

Additional Information

All your information will be kept confidential according to EEO guidelines.