Current jobs related to GxP Systems Lead - Durham - Randstad Life Sciences US

  • Lead Validation Specialist

    3 days ago

    Durham, North Carolina, United States i-Pharm GxP Full time

    Lead Validation Consultant OpportunityWe are seeking a highly experienced Lead Validation Consultant to join our team at i-Pharm GxP. This is a unique opportunity to work on a cutting-edge project at a state-of-the-art facility in RTP, NC.The successful candidate will have a strong background in equipment and cleaning validation, with experience in...

  • Lead Validation Specialist

    6 days ago

    Durham, North Carolina, United States i-Pharm GxP Full time

    Job Title: Lead Validation ConsultantAbout the Role:We are seeking a highly experienced Lead Validation Consultant to join our team at i-Pharm GxP. As a key member of our team, you will be responsible for leading equipment and cleaning validation efforts to ensure seamless operations and compliance.Key Responsibilities:Lead equipment and cleaning validation...

  • Senior Validation Consultant

    6 days ago

    Durham, North Carolina, United States i-Pharm GxP Full time

    Job Title: Senior Validation ConsultantAbout the Role:We are seeking a highly experienced Senior Validation Consultant to join our team at i-Pharm GxP. As a key member of our team, you will be responsible for validating production and cleaning equipment and systems, ensuring seamless operations and compliance.Key Responsibilities:Validate equipment and...

  • Senior Validation Consultant

    2 days ago

    Durham, North Carolina, United States i-Pharm GxP Full time

    Senior Validation Consultant OpportunityWe are seeking a highly experienced Senior Validation Consultant to join our team at i-Pharm GxP. This is a unique opportunity to work on a cutting-edge project at a state-of-the-art facility in RTP, NC.The successful candidate will be responsible for validating production and cleaning equipment and systems, ensuring...

  • Senior Manager, IT SAP Systems

    3 days ago

    Durham, North Carolina, United States Beam Therapeutics Inc. Full time

    Job Title: Senior Manager, IT SAP SystemsBeam Therapeutics Inc. is a leading company in the field of precision genetic medicines. We are seeking a highly skilled Senior Manager, IT SAP Systems to join our team.Job Summary:The Senior Manager, IT SAP Systems will be responsible for providing ongoing support and delivering enhancements for Beam's SAP...

  • Full Stack Web Applications Software Engineer

    2 months ago

    Durham, North Carolina, United States BAE Systems Full time

    Job Description See what you're missing. Spanning air, land, sea, and space, we are developing the technology of tomorrow, delivered today. Drawing strength from our differences, we're innovating for the future. And you can, too. Our flexible work environment provides you a chance to change the world without giving up your personal life. We put our...

  • Lead Scientist in Cell and Gene Therapy

    3 weeks ago

    Durham, North Carolina, United States BioAgilytix Full time

    About BioAgilytix: At BioAgilytix, we are dedicated to exceptional science and its transformative impact on healthcare. Our team comprises highly skilled scientists and professionals who provide customized services to support groundbreaking advancements in medicine through top-tier bioanalytical services. We pride ourselves on being solution-focused and...

  • ERP Analyst

    5 days ago

    Durham, United States Softworld, a Kelly Company Full time

    Job Title: ERP AnalystJob Location: Durham NC 27703, onsite Onsite Requirements:ERP Experience with one of the following: MS Dynamics, SAP, Oracle, NetSuite Experience in Biologics, Pharmaceutical, or other GxP environment Job Description: The ERP System Analyst (using platforms such as Microsoft Dynamics 365, SAP, Oracle, or NetSuite) will serve as the...

  • ERP Analyst

    5 days ago

    Durham, United States Softworld, a Kelly Company Full time

    Job Title: ERP AnalystJob Location: Durham NC 27703, onsite Onsite Requirements:ERP Experience with one of the following: MS Dynamics, SAP, Oracle, NetSuite Experience in Biologics, Pharmaceutical, or other GxP environment Job Description: The ERP System Analyst (using platforms such as Microsoft Dynamics 365, SAP, Oracle, or NetSuite) will serve as the...

  • Lead Operations Strategist

    3 weeks ago

    Durham, North Carolina, United States Kuehne + Nagel Full time

    Lead Operations Strategist | United States | US2078474 At Kuehne+Nagel, we foster a culture of achievement and acknowledgment, providing numerous opportunities for career advancement. If you seek professional growth or simply a rewarding workplace, consider the role of Lead Operations Strategist at our distribution center. YOUR ROLE In this position, you...

  • Lead Operations Strategist

    3 weeks ago

    Durham, North Carolina, United States Kuehne+Nagel Full time

    Join Kuehne+Nagel as a Lead Operations StrategistAt Kuehne+Nagel, we foster a culture that values performance and recognition, providing numerous opportunities for career advancement. If you are seeking professional growth in a dynamic environment, consider the role of Lead Operations Strategist at our distribution center.Your RoleIn this position, you will...

  • Lead IT Engineering Consultant

    2 weeks ago

    Durham, North Carolina, United States CREO Full time

    Job OverviewThe Lead IT Engineering Consultant is tasked with evaluating, designing, implementing, and maintaining IT systems to fulfill organizational goals. This role requires excellent communication and customer service abilities, a strategic approach to business, and substantial technical expertise in enterprise IT engineering support. This includes...

  • Enterprise Resources Planning Specialist

    6 days ago

    Durham, United States Softworld, a Kelly Company Full time

    The ERP System Analyst (using platforms such as Microsoft Dynamics 365, SAP, Oracle, or NetSuite) will serve as the on-site lead, responsible for maintaining and troubleshooting core business applications within a GxP-compliant environment, particularly in the Biologics, Pharmaceutical, or similar industries. The role will function as the liaison between the...

  • Enterprise Resources Planning Specialist

    6 days ago

    Durham, United States Softworld, a Kelly Company Full time

    The ERP System Analyst (using platforms such as Microsoft Dynamics 365, SAP, Oracle, or NetSuite) will serve as the on-site lead, responsible for maintaining and troubleshooting core business applications within a GxP-compliant environment, particularly in the Biologics, Pharmaceutical, or similar industries. The role will function as the liaison between the...

  • Engineering Systems Lead

    3 months ago

    Durham, United States Eli Lilly and Company Full time

    At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities...

  • Lead Systems Engineer

    3 weeks ago

    Durham, North Carolina, United States Fidelity TalentSource LLC Full time

    Fidelity TalentSource serves as your gateway to explore your next temporary opportunity within Fidelity Investments. We are currently seeking a Lead Systems Engineer (Unix/Linux) to join Fidelity's Enterprise Technology division. Impact of Your Role The Enterprise Infrastructure Distributed Hosting team at Fidelity is expanding and looking for a Lead Systems...

  • Mechanical Engineer

    2 weeks ago

    Durham, North Carolina, United States Fujifilm Full time

    Job SummaryFujifilm is seeking a highly skilled Facilities Engineer II to join our team. As a key member of our engineering department, you will be responsible for providing technical support for our GMP/GxP utilities, including high-purity water and HVAC systems.Key ResponsibilitiesProvide technical engineering support for GMP/GxP utilities, including...

  • Senior Software Engineer

    1 month ago

    Durham, North Carolina, United States BAE Systems Full time

    Job Description You don't see it, but it's there. Our employees work on the world's most advanced electronics - from saving emissions in the City of Lights to powering the Mars Rover to protecting the F-35 fighter jet. At Electronic Systems, you'll be among the brightest minds, working on the aerospace and defense industry's most difficult problems. Drawing...

  • Lead Embedded Systems Engineer

    3 weeks ago

    Durham, North Carolina, United States Smart Wires Full time

    About the Opportunity:Join Smart Wires as a Lead Embedded Systems Engineer and contribute to a team that is revolutionizing the energy sector. This role offers the chance to work alongside industry specialists to create innovative solutions that facilitate the integration of renewable energy and enhance consumer electrification.Company Overview:Smart Wires...

  • Lead Research Scientist in Advanced Technologies

    3 weeks ago

    Durham, North Carolina, United States FLIR Systems Full time

    Position Overview:FLIR Systems is on the lookout for a highly skilled Lead Research Scientist to spearhead innovative research and development initiatives in the realm of machine learning and applied mathematics. This role is pivotal in driving our advanced technology applications forward.Company Background:FLIR Systems is renowned for its cutting-edge...

GxP Systems Lead

5 months ago

Durham, United States Randstad Life Sciences US Full time

6 month Contract

Hybrid (Durham or Dallas local)


Systems they will use:

  • Sharepoint for GMP
  • Microsoft
  • Tableau
  • Veeva
  • Docusign
  • One Drive
  • Teams
  • Little bit of configuring involved. Working with the user groups for testing
  • Owner and administrator of GMP systems.


What Skills or Experience MUST our candidates have to be qualified

  • IT Skills/Knowledge background in Biotech, pharma
  • Understands GMP
  • Understand regulations
  • Stand up and qualify electronic systems


Job Description

Overview of Position

This role will report to the Head of IT and lead the implementation, management and maintenance of GxP electronic systems.

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 GxP electronic systems, support users to address technical issues as needed, and ensure overall compliance with 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 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 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 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.