Posted 12 hours ago

Lab Systems Manager

9627 Corixa Corporation United States of America, 200 CambridgePark Drive
Onsite Full Time
Apply on source site

Job description

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 Why you? 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. If you require an accommodation or other assistance to apply for a job at GSK, please contact the appropriate Recruitment Staff by emailing us at - usrecruitment.adjustments@gsk.com GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law. Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site. Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK’s compliance to all federal and state US Transparency requirements. For more information, please visit the Centers for Medicare and Medicaid Services (CMS) website at https://openpaymentsdata.cms.gov/ We are a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years. Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together. Find out more on our career site.

Skills and functions

  • Human Resources