Candidate Profile

The Quality Document Manager is responsible for the lifecycle management of Healthcare R&D Quality Documents in the scope of GLP, GCP and GVP activities. Maintaining a lean and effective Central Quality System enables client R&D adherence to regulatory requirements and therefore is a key element of regulatory inspections.

The main responsibilities are: 

• Responsible for the lifecycle management of the client's Healthcare R&D procedures within the client's Healthcare R&D Quality Management System.  
• Drives globalization, documentation standards, process orientation, simplification, visualization, harmonized core language, regulatory compliance, and harmonization of procedures within the global client's Healthcare R&D Quality Management System. 
• Provides guidance on the use of electronic systems related to Quality Document (QD) management (e.g., the electronic Document Management System (eDMS)/ procedures repository and Business Process Modeling Systems). 
• Provides, where and as necessary, training on the use of the client Healthcare R&D eDMS.  
• Guides and supports R&D departments/Process Owners/QD authors at different stages of the client Healthcare R&D procedures lifecycle. 
• Coordinates approval/authorization of client Healthcare R&D QDs. 
• Ensures timely review/revision of existing QDs within the worldwide client Healthcare R&D QMS. 
• Accountable for the adequate filing, provision, worldwide distribution and archiving of original client Healthcare R&D procedures. 
• Manages decommission of outdated procedures within the client Healthcare R&D QMS 
• Establishes and manages an information system to alert all R&D employees worldwide about newly released and/or decommission/superseded procedures.  
• Collaborates with the R&D Training Team to secure appropriate and timely training on client Healthcare R&D procedures worldwide.  
• Contributes to and/or supports Health Authority inspections and internal audits (e.g., responds to questions on the management of R&D procedures and/or by providing requested information and documents) 
• Coordinates suppliers/vendors/partners access to current versions of client Healthcare R&D procedures as needed and contractually agreed.  

EDUCATION & LANGUAGES

•      Masters University degree (preferably in Pharma/Life Science related subject) or equivalent professional experience and expertise

•      Lean & Six Sigma certification is a plus

•      Business Process Management certification is a plus

PROFESSIONAL SKILLS & EXPERIENCE

•      Experience of at least 3 years in process design, description, and good writing skills (e.g., as Medical or Technical Writer)

•      Minimum 2 years Quality Assurance experience or relevant experience in quality management, biopharmaceutical, clinical development, or regulatory compliance is a plus.

•      Extensive working knowledge of international regulations and broad working knowledge in compliance areas of GCP, GVP, GLP

•      Broad understanding of the drug development process and regulatory environment including specific areas of interest for client Healthcare

•      Professional experience in an international environment for more than 3 years

•      Professional experience in project management

•      Professional experience in several international pharmaceutical organizations is a plus

PERSONAL SKILLS & COMPETENCIES

•      Fluent in English in both, speaking and writing.

•      Strong documentation management skills.

•      Persuasive communication skills

•      Analytical mindset to develop effective business and competitive strategies for dealing with current and future industry trends.

•      Fosters an environment that nurtures open dialogue and encourages people to raise and discuss critical issues and recognizes the needs and opportunities for these discussions.

•      Consistently demonstrates a global thinking/mindset with balanced cultural awareness, sensitivity and accommodating behaviors. Excellent understanding of the requirements of the pharmaceutical industry and in particular drug development with good knowledge in the area of Quality Management Systems and Good Documentation Practice.

•      Awareness of the different Quality Documentation management approaches and related processes.

•      Ability to prioritize and work in rapidly changing environment.

•      Multicultural approach.

•      Ability to manage time and resources effectively.

•      Independent but collaborative working style.

•      Demonstrate an agile mindset and advanced skills in MS Word are essential.