Data integrity Program Manager
In this role you will be responsible for implementing and leading an Enterprise-wide, cross-functional program on Data Integrity (DI), Data Management and Digitalization. This role will include the Project Management of the Global Data Integrity program and the co-ordination with the various sites and laboratories in the West network to ensure execution to project plan. You will establish DI and management standards by creating the required Enterprise Procedures for processes like Audit Trail Review, Computerized System Validation and backup of electronic raw data and will facilitate their implementation at all affected functions.
Essential Duties and Responsibilities:
- Establishes and leads a formal DI program at West, including project charter, reporting of regular status updates, stakeholder communication and organization of steering committee meetings
- Supports all affected functions in bringing their systems and processes into compliance with GMP and DI principles and in maintaining that state.
- Facilitates creation of Enterprise procedures on relevant DI and management topics and support all affected functions in their implementation, such as
- Computerized System Validations
- Excel Spreadsheet verifications
- Archiving of electronic raw data
- Supports all relevant functions as West´s global SME on DI.
- Works with external consultants, trainers, etc., to identify the best strategy and implementation tactics for DI, including necessary interim solutions
- Establishes a communication strategy for typical customer questions on DI, e.g. during audits, and educates the relevant functions accordingly (Quality, Laboratory, TCS, Sales)
- Closely monitors regulatory developments and new guidelines in the area of DI and drives their implementation at West, if needed.
- Proactively identifies opportunities for continuous improvement of West´s DI compliance and Digitalization of processes (transformation)
- Lead the identification of key quality data that is entered into our business system, assess areas of enhancement in data enter and develop an auditing program to ensure the identified key quality data points are entered and maintained at a GMP level across the modules such as OOS / CAPA / Audits / Deviation and Complaints
- Drive a culture of compliance to Data Integrity across the business and lead initiates to maintain this focus and build on this culture
- Other duties as assigned
Education and Experience:
- Bachelor of Science in Science or IT related discipline
- Minimum of 5-10 years of professional experience in a GMP regulated environment
- Experience in leading global and cross-functional projects
- Experience with SAP QM, LIMS, and other Laboratory related applications is a plus
- Experience in Lab Instrumentation / IT Experience is a plus
Knowledge, Skills and Abilities:
- Proficiency in English, additional languages are a plus
- Good project management skills
- Good communication and influencing skills
- Able to be aware of all relevant SOPs as per Company policy as they are related to the position covered by this Job Description
- Data Integrity knowledge / experience
- Able to comply with the company’s safety policy at all times
- Able to comply with the company’s quality policy at all times.
- Dynamic working environment
- Excellent work conditions
- Organized transport to and from Kovin for employees lives in Belgrade and Pancevo
- Personal and professional development
- Modern and comprehensive learning management system
- Private health insurance for you and your family members
- Modernly designed and equipped canteen with cooked meals
- Friendly and dynamic team who will support you from the beginning