IT Validation Manager for Digital Compliance and Quality Assurance
2 months ago
About the Company
Ascendis Pharma A/S is a fast-growing global biopharmaceutical company that applies its trademark TransCon technology to build a leading, fully integrated biopharmaceutical company focused on making a meaningful difference in patients' lives.
We are guided by our core values of patients, science, and passion, and we use our TransCon drug development platform to fulfill our mission of developing new and potentially best-in-class therapies to address unmet medical needs.
About the Role
We are seeking an experienced IT Validation Manager to join our Product Team supporting our Finance and Product Supply business functions, mainly through our Microsoft Dynamics 365FO platform. As an IT Validation Manager, you will play a crucial role in planning and executing GxP validation activities, developing and implementing the structure and processes required to provide robust traceability.
Your Key Responsibilities
- Own the GxP validation and quality deliverables for the Microsoft Dynamics 365 Finance & Operations processes and system, including oversight and planning of all related activities.
- Manage the assessment of technology solutions and vendors to ensure adherence to software development best practices.
- Influence, develop and maintain the test strategy to ensure the system is validated against user, functional and design requirements.
- Evaluate changes to define the level of validation required in coordination with IT QA and Compliance to ensure that we remain in control and that the system remains fit for intended use.
- Ensure team focus on quality deliverables.
- Deliver according to Ascendis Pharma's Quality Management System and ensure timely initiation and closeout of all quality events (changes, deviations and CAPAs).
- Ensure communication, documentation and coordination of risks, validation, and test activities.
Qualifications and Skills
You hold a relevant academic degree – preferably a Master within IT, Production, pharma, or something completely different with relevance to GxP validation and IT solution – and 5 years of experience within pharma and validation management. It will be an advantage if you have a Test manager certificate and an Agile certification and/or experience from an agile setup.
You have a structured and pragmatic approach to Governance, Risk Management, and new technologies. You aspire to become a validation expert with a holistic approach to planning and execution.
You prefer knowledge of Microsoft D365 Finance & Operations or other Enterprise Resource Planning platform. Business process knowledge within product supply: logistics, supply chain or QA is also desirable.
About You
You are self-driven and ready to take responsibility from day one. You are agile at heart; your approach is entrepreneurial and you enjoy finding simple solutions to complex scenarios.
You are a strong team player, analytical, and have a can-do attitude. You possess an entrepreneurial mindset and can thrive in an informal, open environment where innovation and change are key.
You think on your feet and keep your composure when things move quickly. Last but not least, you have a good sense of humor and enjoy working across functions and cultures.
Benefits
You can expect an attractive remuneration package, short- and long-term incentives, pension scheme, and health insurance. To succeed in your job and expand in your role, you and your manager will continuously have Impact conversations about how to propel your development.
We find a way to help you grow. Our headquarters resides in a modern and bright office facility in Hellerup with a view of the harbor, the canals, and the sea. Employees can work from home up to two days per week.
Laptop, iPhone, paid internet, and home office equipment are provided. A thorough and structured onboarding program ensures a smooth transition into your new role.
About Your Work Environment
We offer an exciting and challenging position in an entrepreneurial and international company with a short line of command. You will be involved in activities that are central to Ascendis Pharma's strategy and work with highly skilled and experienced colleagues on advancing an exciting product pipeline.
Travel
Approximately 10 days per year. Office location: Ascendis Pharma Headquarter, Hellerup.
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