To strengthen our Validation Team we are looking for a Global Computer System Validation Manager. In this role you will be responsible for the planning, organization and implementation of global IT Computer System Validation projects (CSV). You will also support local organizations with the implementation and execution of local CSV activities. The projects include, but are not restricted to, SAP, MES, and Apps as Medical Devices. The role holder will manage the validation of new systems, as well as changes to existing systems, and will work closely with the business process owners, lead solution architects, and IT service provider team to ensure that CSV requirements are met.
This role will take on responsibility for the CSV elements for all systems by creating and reviewing validation plans and other validation deliverables, reviewing testing coverage to ensure adequacy, performing system and supplier assessments, manage the change control process, and conduct risk analysis in order to drive and implement process improvements as required. This will include advising on compliance with and potential changes to existing procedures, processes and templates as necessary, together with the provision of appropriate training to members of the Global IT function and business users as necessary.
What we offer
- International projects and teams
- A motivating working environment where your initiatives and strengths are appreciated
- Diverse and interesting assignments
- Training and individual development opportunities
- An open-minded, creative, "Can DO"-culture
- Your responsibilities
- Leading software validation activities for design and development projects, to ensure a high level of process and product quality for FDA / EU
- Assist the CSV Lead in defining the global IT validation strategy and approach taking into account the relevant GxP requirements (e.g. EU GMP Annex 11, FDA 21 CFR Part 11, Part 820, etc.) and also other relevant regulatory requirements (e.g. data privacy/protection)
- Develop, review and approve CSV policies, procedures, plans and protocols, and champion their adoption
- Manage and control validation documentation in collaboration with QA teams
- Manage, coordinate, and/or perform the development of: Validation and Test plans, specifications (e.g. User Requirements Specification, Functional Specification, etc.) supplier assessment, user acceptance testing, traceability, and compilation of the data and results into final reports
- Schedule and lead meetings with IT, QA, and end user representatives in order to gain cross functional understanding and consensus on project content and execution
- Review proposed changes to validated computerized systems and identify the validation requirements necessary to maintain the system’s validation status after execution of the change
- Maintain up to date knowledge of evolving regulatory requirements, availability of current/new techniques, and literature regarding compliant computer operations, and act as an information resource for the team and wider business
- Periodic reviews of validated global computer systems
- Assist during audits and inspections at company plants, for subcontractors and service providers
- Degree or equivalent qualification in a relevant discipline combined with significant experience in similar validation role within the healthcare industry and a thorough knowledge and understanding of the GxP regulations and CSV requirements and expectations.
- Demonstrable experience of successfully managing complex validation projects
- Minimum 3 years´ industrial experience, preferably inIT validation, quality assurance or management or product quality area in the pharmaceutical industry
- In-depth knowledge of the applicable quality management and CSV standards (ISO 13485, EU GMP Annex 11, FDA 21 CFR 11, GAMP5)
- Experience in dealing with medical device and pharmaceutical regulations (MDD 93/42 / EEC, MPG, etc.)
- Experience of involvement in regulatory inspections and audits, able to act as lead contact for the CSV validation program for inspectors during inspections and audits.
- Strong technical skills with demonstrated ability to provide solutions to a variety of technical problems of moderate scope and complexity
- Ability to learn quickly and respond to changing priorities
- Change management skills (stakeholder management, communications strategy and planning, knowledge management, training, etc.).
- Project management and organizational skills as well as reliability, teamworkand social competencies
- Conduct independent, result oriented and confident communication in an international environment
- Strong problem solving skills
- Experienced with basic PC skills (MS Word, Excel, PowerPoint, and Project)
- Fluent German and English language skills, both written and spoken
- Ability to travel globally
- Qualification as an auditor is desirable
- SAP and/or MES experience an advantage