Senior Compliance Manager

3 days ago

Hyderabad Secunderabad Telangana, India beBeeGxp Full time
About this Role

We are seeking an experienced GxP Compliance Specialist to join our team.

  • The successful candidate will be responsible for ensuring the quality and compliance of computerized systems, including review and approval of project-related documents, determination of GxP applicability, and establishment of trusted partnerships with IT functions.
  • They will also perform supplier qualification assessment activities, provide audit support as assigned, and contribute to the preparation of VMPs and execution of plans for systems associated with respective functions.
Key Performance Indicators
  • GxP relevant computerized systems are developed, implemented, and maintained according to Novartis requirements.
  • On-time review and approval of changes, deviations & periodic review reports for GxP computerized systems.
  • Documentation supporting eCompliance and CSV requirements is in place, maintained up-to-date, and can be presented during audits and inspections without delays and issues.
  • Gaps in eCompliance and CSV activities are proactively identified, escalated, and mitigation plans supported.
  • Client / stakeholder satisfaction and corresponding feedback.
Required Skills and Qualifications
  • Good understanding of global regulations and Health Authorities expectations governing computerized systems (CSV, Part 11, etc.).
  • Good experience in development, implementation, and lifecycle management of computerized systems in regulated environments.
  • Experienced in operational management of GxP solutions, including related technologies to support operation.
  • Experience in GxP supplier qualification activities.
  • Good understanding in system application management, its Quality support approach, and industry best practices (ITIL, ITSM, etc.).
  • Experienced in development, implementation, and lifecycle management of key computerized systems in Pharmaceutical Development, Manufacturing, Quality, Commercial, and Infrastructure space.
  • Successful cross-divisional/functional work with complex international teams.
  • Ability to adjust to multiple demands, shifting priorities, and unexpected events while maintaining a positive work attitude.
  • Ability to effectively interact and present to Management.
  • Ability to influence without hierarchical authority and build trusted partnerships.
  • Self-starter with experience in initiating and delivering projects and processes.
  • Excellent communication, negotiation, facilitation, and interpersonal skills.

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