GxP Systems Lead

2 weeks ago

Durham, United States Beacon Hill Full time

To be successful in this role, the candidate will possess a patient-focused Quality mindset, technical expertise, communicate clearly and effectively (in verbal and written form), and display exemplary organizational and leadership skills. The candidate will contribute to an environment in which the team is highly motivated and engaged to work collaboratively and cross-functionally to deliver exceptional results and ensure long-term success.


Essential Duties & Responsibilities

  • Act as SME and technical system owner / administrator for internal GxP electronic systems, support users to address technical issues as needed, and ensure overall compliance with company data integrity programs and policies.
  • Work with end users / user groups to ensure new system requests are assessed and evaluated to ensure investment decisions are made which align with company strategy and meet a clear business need.
  • Work directly with user groups, cross-functional teams and solutions providers to ensure that new systems are specified, delivered, operated and maintained in a compliant state.
  • Ensure plans for new system deliveries are thoroughly developed and communicated to key stakeholders, that project and system risks are assessed and mitigations are in place, and that all deliverables are completed to ensure timely system implementation and go-live.
  • Partner with Validation and Quality to ensure that GxP systems are assessed, tested and documented appropriately, and support policy / procedure development, change management, deviations or investigations related to internal GxP electronic systems.
  • Build strong relationships with system vendors and SaaS providers to ensure system knowledge is current regarding features, updates, security patches, etc.
  • Proactively identify opportunities to improve existing processes, equipment, systems and infrastructure.
  • Act as business partner to ensure effective communication between internal GxP functions and the IT team, and support those functions by proactively identifying and developing technology solutions where required.


Basic Requirements

  • Bachelor's or Master’s degree in a scientific discipline (e.g., Computer Science, Engineering, Biology, Chemistry, etc.)
  • Minimum 10+years experience in the Biotechnology or Pharmaceutical industry
  • Strong GMP, GDPR and SDLC knowledge with demonstrated experience developing and delivering applications and SaaS deployments from concept to go-live in a late-stage clinical or GMP environment.

Preferred Qualifications

  • Experience with applications or SaaS supporting de-centralized Cell and Gene Therapy clinical trials desirable
  • Experience supporting configuration, qualification and maintenance of SharePoint, Veeva, DocuSign, etc.

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