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Business Introduction
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, making sure that we focus our efforts on accelerating 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.
Find out more:
Our approach to R&D
Position Summary
The senior technical expert will actively contribute for 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.
Ensure identification and application strategy of appropriate OT/Cyber Security controls for CAPEX projects
As R&D point of contact for Tech Strategies and Risk group (Accountable for Cyber Security at GSK), provides expertise support in the implementation of GSK Vaccines OT Security requirements
You will work in partnership with a broad range of stakeholder groups such as Quality, Computer System Validation, Tech, Procurement and R&D scientific platforms to foster Innovation and proactively define standards, identify cost saving opportunities and accelerate generation of scientific results
Manage internal network of local and global experts and ensure sharing of best practice and learnings in area of expertise
For systems used in non-regulated environment, will define and/or review technical mitigation and remediation strategies, leading to the respect of the Data Integrity principles, by monitoring and assessing industry trends, new solutions on the market, but also evolving regulatory expectations
For systems used in a regulated (GxP) environment, defines and approves, as Technical Owner, the Integration, Configuration and Life Cycle Management for validated systems. She/he will lead/ be accountable for activities such as technical Audit preparation, Periodic reviews, Services Catalogue upgrades, Change Management, etc.
Key responsibilities include:
This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:
With a high degree of autonomy and in a team of IT-skilled profiles, dedicated to the management of computerized lab systems:
Ensures for CAPEX projects, the definition of landscape design for “computerized system(s)”, in respect to Tech rules, but also to Data Integrity and Cyber Security standards
Leads integration of complex Client-Server solutions, cross-platforms or cross-sites
Communicates & shares detailed knowledge of best practices & current trends, acquired both internally & externally on Cyber Security Threats and Protection
Embeds Cyber Security into all solutions and ways-of-working along the system’s life cycle
Defines plans for “Systems’ Life Cycle Management” aspects, such as:
Maintenance and Support Model
“Back-up and Restore” strategy for the data
Disaster Recovery” strategy for the system
Obsolescence management (upgrades, migrations, replacements)
Ensures creation of integration and configuration documents: Design specifications, Installation Scenario, Post-Installation Guide the activation/ configuration of specific modules such as Access Management, Audit Trail, etc. in collaboration with business, QA and CSV
Review/Approve “validation documentation” and other deliverables in the scope of the release and validation of R&D Computerized Systems (non-GxP as well as GxP)
For new computerized systems, define the best network integration strategy in collaboration with the equipment supplier, Tech, QA and CSV
Review/analysis of user requirements and computerized systems specifications prior to equipment purchase. Provide technical recommendations and highlight integration and/or configuration constraints based on Tech, CSV and Data integrity rules and policies
Lead and coordinate activities such as Periodic reviews, Services Catalogue upgrades, Change Management, etc.
Ensures prioritization of operational activities according to Business requirements and available capacity within the team (GSK staff as well as external workforce)
Review/Approve “qualification/validation documentation” of R&D Computerized Systems
In the context of the Data Integrity program in R&D, ensures the feasibility and detailed definition of the technical mitigations to put in place for non-compliant Computerized Systems.
Ensures efficient and effective coordination of activities with the Functional Services Provider, including definition of guidelines on the expected technical solutions to be delivered
Create SOP/WKI and other guidance documents in the field of expertise
Lab Systems Integration (Tech Infrastructure, Network, etc.)
Analytical Software Management
Application of Cybersecurity mitigations and standards
Data Integrity mitigations and remediations
Cover the role of “OT Custodian” for Vx R&D that includes below activities:
Establish and maintain effective lines of communications with the Tech service owner
Ensure that changes to the service provision are properly reflected in OT security controls
Agree any proposed site-specific or asset related exceptions to OTESSs (OT Enabling Service Specifications)
Take said exceptions to OTN-CAB for review and approval
Basic Qualifications:
We are looking for professionals with these required skills to achieve our goals:
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
Experience and advanced knowledge in IT industry standards and practices
Preferred Qualifications:
If you have the following characteristics, it would be a plus:
Proven experience in the field of analytical lab equipment (e.g. GAMP, CFR 21)
Highly comfortable with working in a diverse, ambiguous and a fast-paced environment.
Ability to manage risks, define risk-based strategies.
Ability to challenge and debate issues.
Ability to quickly assimilate facts and data and develop an understanding of complex matters.
Strong analytical skills with drive to synthesize the story into an actionable set of recommendations
Assesses needs & constraints and converts these into a realistic solution
Is resourceful on innovation opportunities in the area of expertise
Project management and change management
#GSK-LI
Skills
Artificial Intelligence (AI), Business Analysis, Data Analysis, Data Mining, Digital Fluency, Organization Transformation, Product Development, Project Management, Security System Design
• 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 $119,625 to $199,375. The US salary ranges take into account a number of factors including work location within the US market, the candidate’s skills, experience, education level and the 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 which is dependent on the level of the role. Available benefits include health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and paid caregiver/parental and medical leave. If salary ranges are not displayed in the job posting for a specific country, the relevant compensation will be discussed during the recruitment process.
Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.
Why GSK?
Uniting science, technology and talent to get ahead of disease together.
GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale.
People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.
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