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IT Validation Manager

Company: Ascendis Pharma
Location: Palo Alto
Posted on: January 7, 2022

Job Description:

Do you want to be part of building a fully integrated biopharmaceutical company together with a team of highly skilled colleagues who are passionate about developing best-in-class therapeutics that address significant unmet medical needs? Then Ascendis Pharma is committed to supporting your professional development on our journey.

Ascendis Pharma is looking to hire an experienced IT Validation Manager to join our team. This is an exciting opportunity to join a rapidly growing, innovative company!

Position Summary

The IT Validation Manager role is part of a team that plans, develops, implements, manages, maintains, and supports various business applications and systems. The individual will be responsible for driving IT compliance and ensuring the applications are kept in a validated state; will lead the validation activities during implementation and life cycle management of the computerized systems; will be supervising and driving the development and maintenance of validation activities for one of more projects involving cross functional stakeholders globally. The position will be based in Palo Alto and will report directly to the Head of US IT.

Key Responsibilities

  • Lead the validation for implementation and maintenance of applications within the framework of regulation (GxP, 21CFR11, GDPR, SOX etc.) This also includes participation in release management.
  • Define a risk-based quality strategy for implementation of IT systems together with the product team.
  • Together with specialists within SOX controls, lead the task to ensure the framework for SOX controls are developed, maintained and controls executed.
  • Ensure test activities are planned, coordinated, and approved in collaboration with an external support partner.
  • Responsible for the oversight of ongoing validation activities, identify risks and report these to product team.
  • Participate in inspections by Regulatory Authorities including DKMA and FDA.
  • Responsible for the validation documentation ensuring compliance with IT QMS and the QA team.
  • Advise and train team members about best practices for validation deliverables, including requirements, test scripts, etc.
  • Review of vendor documentation and creation or approval of in-house protocols and reports to deliver a complete package of qualification documentation.
  • Close liaison with the partner for Application and Infrastructure Support and Maintenance ensuring full overview and status on quality/compliance activities.
  • Coordinates communication within the project team, escalates and facilitates the resolution of risks, issues, and changes.
  • Effectively interfaces and communicates with senior management and all key stakeholders regarding validation and compliance related activities.
  • Oversees validation deliverables and activities all phases of solution implementation and the corresponding project and quality documentation to ensure compliance.
  • Functions as a liaison between the Project team, Quality and IT Compliance for software compliance related activities and deliverables, including deviations, corrective actions, periodic reviews, etc.
  • Key member of the IT Compliance team, responsible for the development of Ascendis' IT QMS processes based on industry trends and recommendations.
  • To coordinate and manage continuous improvement of IT Systems validation and compliance across Ascendis.
  • Play a key role on the IT PMO to contribute towards efforts to mature project management and validation methodologies at Ascendis.
  • Maintain an up-to-date knowledge on latest process optimization technologies and compliance regulations within the pharmaceutical industry.
  • Contribute to the support and maintenance of validation package in compliance with validation/documentation procedures as per IT QMS processes.

    Requirements
    • Minimum level of education and years of relevant work experience:
      • Bachelor's degree in a related discipline and a minimum of 7 years of progressively responsible experience in related roles (including a minimum of 3 years of demonstrated IT computer systems validation and compliance experience) in a pharmaceutical, biotechnology or related environment.
      • Experience preparing and presenting summary information and proposals to senior leadership.
      • Special knowledge or skills needed and/or licenses or certificates required:
        • Proven track record in managing system validation and test activities
        • Working in an agile team, relentlessly improving working practices
        • Managing stakeholders including external vendors
        • Ideally you have experience with automated testing and DevOps.
        • Expert experience implementing vendor software, particularly Software As A Service (SaaS).
        • Experience validating and documenting software, specifically using methods other than the traditional V-model, while adhering to quality and compliance mindset.
        • Demonstrated ability to manage a team of consultants responsible for the validation activities and deliverables.
        • Able to adjust to multiple demands, dealing with ambiguity, shifting priorities and unexpected events while maintaining a positive and constructive attitude.
        • Able to structure and present complex situations to various set of stakeholders - including communication of compliance or IT-related concepts to a non-IT audience.
        • Proficient with Microsoft Office (including extensive/applied experience using MS Project).
        • Excellent verbal and written communication and skills.
        • Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members.
        • Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
        • Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects.
        • Demonstrated experience leading cross-functional teams
        • Advanced PowerPoint and Excel capabilities
        • Travel requirements: 5% - 10%

          Benefits
          • Medical insurance
          • Vision insurance
          • Dental insurance
          • 401(k)
          • Paid maternity leave
          • Paid paternity leave
          • Commuter benefits
          • Disability insurance

            San Francisco and Los Angeles applicants: The Company will consider for employment qualified applicants with Criminal Histories in a manner consistent with the requirements of the Los Angeles Fair Chance in Hiring Ordinance or the San Francisco Fair Chance Ordinance (as applicable).

Keywords: Ascendis Pharma, Palo Alto , IT Validation Manager, IT / Software / Systems , Palo Alto, California

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