Senior Manager, Regulatory Operations Specialist

3 dni temu

Poznań, Greater Poland GlaxoSmithKline Pełny etat

At GlaxoSmithKline (GSK), we are seeking a talented Senior Manager to join our team as the Business System Owner for Veeva Regulatory Vault. As a key member of our regulatory operations team, you will be responsible for overseeing the strategic management and continuous improvement of this critical business system.

This role is instrumental in ensuring that Reg Vault effectively supports global regulatory operations, compliance, and business objectives. You will foster collaboration with other BSOs and systems, drive innovation, and align with GSK's regulatory strategy.

The successful candidate will have extensive experience delivering business operational support to critical regulatory systems in a global environment. They will also possess expert-level knowledge of Veeva Regulatory Vault, including key objects, Dynamic Access Control, and assessing validation impacts of Veeva releases.

Key Responsibilities:
  • Strategic Leadership: Provide strategic direction and leadership to the team of Business System Owners, ensuring alignment with GSK's global regulatory operations and business objectives.
  • System Management: Oversee the management, maintenance, and optimization of key regulatory business systems to ensure they meet the needs of regulatory operations and compliance requirements.
  • Cross-Functional Collaboration: Collaborate with Regulatory Affairs, IT, Quality, and other cross-functional teams to ensure regulatory systems support end-to-end regulatory processes and business needs.
  • Innovation and Improvement: Drive continuous improvement initiatives for regulatory systems, leveraging new technologies and best practices to enhance system performance, user experience, and data integrity.
  • Compliance and Risk Management: Ensure regulatory systems comply with global regulatory requirements and internal standards, and proactively identify and mitigate risks associated with system usage and data management.
  • Project Oversight: Oversee the planning, execution, and delivery of projects related to regulatory system enhancements, upgrades, and new implementations, ensuring they are completed on time and within budget.

Required Skills and Qualifications:

  • Bachelor's degree in a relevant field such as Life Sciences, Pharmacy, Regulatory Affairs, Information Technology, or a related discipline.
  • Relevant professional certifications such as Regulatory Affairs Certification (RAC), Project Management Professional (PMP), or certifications in IT systems management or data governance.
  • Expert-level knowledge of Veeva Regulatory Vault, including key objects, Dynamic Access Control, and assessing validation impacts of Veeva releases.
  • Extensive experience delivering business operational support to critical regulatory systems in a global environment.
  • Ability to communicate and provide assistance and support on both sides of the Business-IT interface.

Benefits:

  • Opportunity to work with a leading global healthcare company.
  • Hybrid work arrangement (2/3 days per week from the office).
  • Contract of employment.
  • Attractive reward package, including annual bonus and recognition awards for outstanding performance.
  • Life insurance and pension plan.
  • Private medical package with additional preventive healthcare services for employees and their eligible dependents.

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