Job Information
Randstad US gxp systems lead in research triangle park, North Carolina
gxp systems lead.
research triangle park , north carolina
posted may 8, 2024
job details
summary
$65 - $71 per hour
contract
bachelor degree
category life, physical, and social science occupations computer and mathematical occupations
reference48063
job details
job summary:
Job Description
Overview of Position
Biotech Company is seeking an experienced pharmaceutical industry leader to work in our Engineering and Operations team as a contract GxP Systems Lead. This role will report to the Head of IT and lead the implementation, management and maintenance of Biotech' company 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.
location: Durham, North Carolina
job type: Contract
salary: $65 - 71 per hour
work hours: 8 to 4
education: Bachelors
responsibilities:
ssential 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.
qualifications:
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.
skills: GMP (Good Manufacturing Practice)
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.
Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including health, an incentive and recognition program, and 401K contribution (all benefits are based on eligibility).
Applications accepted on ongoing basis until filled.