Lab Systems Manager

At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. Our R&D focuses on discovering and delivering vaccines and medicines, combining our understanding of the immune system with cutting-edge technology to transform people’s lives. GSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, ensuring our efforts accelerate significant assets that meet patients’ needs and have the highest probability of success. We’re uniting science, technology, and talent to get ahead of disease together.

About the role

The senior technical expert will actively contribute to the definition of network integration strategies for R&D computerized systems, in line with GSK Tech rules and policies, based on business requirements and following QA recommendations. This role ensures the identification and application strategy of appropriate OT/Cyber Security controls for CAPEX projects. As the R&D point of contact for Tech Strategies and Risk group (Accountable for Cyber Security at GSK), you will provide expertise in implementing GSK Vaccines OT Security requirements.

You will collaborate with a broad range of stakeholders such as Quality, Computer System Validation, Tech, Procurement, and R&D scientific platforms to foster innovation, define standards, identify cost-saving opportunities, and accelerate scientific results. This role involves managing an internal network of local and global experts to share best practices and learnings.

For systems used in non-regulated environments, you will define and/or review technical mitigation and remediation strategies to ensure Data Integrity principles are respected by monitoring industry trends, new solutions, and evolving regulatory expectations. For systems in a regulated (GxP) environment, you will define and approve, as Technical Owner, the Integration, Configuration, and Life Cycle Management for validated systems, leading activities such as technical audit preparation, periodic reviews, service catalogue upgrades, and change management.

Responsibilities

• Define landscape design for “computerized system(s)” in CAPEX projects, ensuring compliance with Tech rules, Data Integrity, and Cyber Security standards.
• Lead the integration of complex Client-Server solutions across platforms or sites.
• Communicate and share detailed knowledge of best practices and current trends in Cyber Security threats and protection.
• Embed Cyber Security into all solutions and ways-of-working throughout the system’s life cycle.
• Define plans for “Systems’ Life Cycle Management,” including:
  • Maintenance and Support Model
  • “Backup and Restore” strategy for data
  • “Disaster Recovery” strategy for the system
  • Obsolescence management (upgrades, migrations, replacements)
• Create integration and configuration documents, such as Design specifications, Installation Scenario, and Post-Installation Guide.
• Guide the activation/configuration of specific modules (e.g., Access Management, Audit Trail) in collaboration with business, QA, and CSV.
• Review and approve “validation documentation” and other deliverables for the release and validation of R&D Computerized Systems (non-GxP and GxP).
• Define the best network integration strategy for new computerized systems in collaboration with equipment suppliers, Tech, QA, and CSV.
• Review and analyze user requirements and computerized systems specifications prior to equipment purchase, providing technical recommendations and highlighting integration/configuration constraints.
• Lead and coordinate activities such as Periodic reviews, Services Catalogue upgrades, and Change Management.
• Prioritize operational activities based on business requirements and team capacity (GSK staff and external workforce).
• Review and approve “qualification/validation documentation” of R&D Computerized Systems.
• Ensure feasibility and detailed definition of technical mitigations for non-compliant Computerized Systems within the Data Integrity program in R&D.
• Coordinate activities with the Functional Services Provider, including defining guidelines for expected technical solutions.
• Create SOP/WKI and other guidance documents in areas such as Lab Systems Integration, Analytical Software Management, Cybersecurity mitigations, and Data Integrity remediations.
• Serve as the “OT Custodian” for Vx R&D, including:
  • Establishing and maintaining effective communications with the Tech service owner.
  • Ensuring changes to service provision are reflected in OT security controls.
  • Agreeing on site-specific or asset-related exceptions to OTESSs (OT Enabling Service Specifications) and presenting them to OTN-CAB for review and approval.

Requirements

• Degree in Life Science, Engineering, or equivalent experience.
• 5+ years’ experience in management of IT or Automation team/project.
• Expertise in defining network integration solutions for computerized lab systems.
• Advanced knowledge of IT industry standards and practices.

Qualifications

• Proven experience in the field of analytical lab equipment (e.g., GAMP, CFR 21).
• Comfortable working in a diverse, ambiguous, and fast-paced environment.
• Ability to manage risks and define risk-based strategies.
• Strong analytical skills with a drive to synthesize information into actionable recommendations.
• Ability to assess needs and constraints, converting them into realistic solutions.
• Resourcefulness in identifying innovation opportunities.
• Project and change management experience.

Skills

• Artificial Intelligence (AI)
• Business Analysis
• Data Analysis
• Data Mining
• Digital Fluency
• Organization Transformation
• Product Development
• Project Management
• Security System Design

Pay

If you are based in Cambridge, MA; Waltham, MA; Rockville, MD; or San Francisco, CA, the annual base salary for new hires in this position ranges from $119,625 to $199,375. The US salary ranges consider factors such as work location, candidate’s skills, experience, education level, and market rate for the role. In addition, this position offers an annual bonus and eligibility to participate in our share-based long-term incentive program, dependent on the role level.

Benefits

• Health care and other insurance benefits (for employee and family).
• Retirement benefits.
• Paid holidays, vacation, and paid caregiver/parental and medical leave.