Global Validation Manager for Pharmaceutical Solutions

6 days ago

Gentofte, Gentofte Kommune, Denmark ASCENDIS PHARMA AS Full time
Ascendis Pharma A/S

We are a fast-growing global biopharmaceutical company with a short line of command, offering an exciting and challenging position in an entrepreneurial and international environment.

About the Role:

We are seeking a passionate IT Validation Manager to join our product team in Hellerup. As a key member, 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.

This is an exciting opportunity to work in a fast-paced environment, collaborate with cross-functional, global teams, and achieve extraordinary results.

Your Key Responsibilities:

  • Owning GxP validation and quality deliverables for Microsoft Dynamics 365 Finance & Operations processes and system.
  • Managing the assessment of technology solutions and vendors to ensure adherence to software development best practices.
  • Influencing, developing, and maintaining the test strategy to ensure the system is validated against user, functional, and design requirements.
  • Evaluating changes to define the level of validation required in coordination with IT QA and Compliance.
  • Ensuring team focus on quality deliverables.
  • Delivering according to Ascendis Pharma's Quality Management System and ensuring timely initiation and closeout of all quality events.
  • Ensuring communication, documentation, and coordination of risks, validation, and test activities.

About You:

You hold a relevant academic degree, preferably a Master within IT, Production, or pharma, with 5 years of experience within pharma and validation management. A structured and pragmatic approach to Governance, Risk Management, and new technologies is essential.

Your Qualifications:

  • A quality mindset aspiring to become a validation expert with a holistic approach to planning and execution.
  • Knowledge of Microsoft D365 Finance & Operations or other Enterprise Resource Planning platform.
  • Business process knowledge within product supply: logistics, supply chain, or QA.
  • 5 years of validation-related discipline experience in the pharmaceutical or medical device industry.
  • Great stakeholder competences and communication skills.

What We Offer:

  • An attractive remuneration package, including a salary range of DKK 650,000 - 850,000 per annum, plus benefits such as pension scheme, health insurance, and flexible working hours.
  • Continuous professional development opportunities, including Impact conversations with your manager.
  • A modern and bright office facility in Tuborg Havn, Hellerup, with a view of the harbor and sea.
  • The option to work from home up to two days per week.
  • Laptop, iPhone, paid internet, and home office equipment.
  • A thorough and structured onboarding program.
  • Soft drinks, fresh fruit, and lunch every day in our canteen.

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