IT Business Partner, R&D Solutions

Location
San Francisco, CA, United States
Posted
Nov 16, 2020
Ref
936
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
IT BUSINESS PARTNER, R&D SOLUTIONS

Position Summary:

The IT Business Partner, R&D Solutions will collaborate with internal and external stakeholders to develop and implement technology solutions in support of IT and business strategy. This includes the ability to lead continuous business process improvement, view the end-to-end business, and fulfill and anticipate business and customer needs with innovative data solutions that help achieve the overall company objectives.

This position will support the research and development (GxP and Non-GxP) organizations across multiple disciplines such as Serialization, Quality Management Systems, Learning Management Systems, Electronic Document Management systems, Computer Systems Validation, Regulatory Information Management System and Veeva eTMF.

Essential Duties and Responsibilities:
  • Develop project definition in partnership with business sponsors for multiple, concurrent projects. This includes facilitating requirements gathering and process mapping
  • Continually assess business needs and implement measures that will ensure business expectations are met or exceeded by enhancing system capability and performance
  • Manages moderately sized projects with some multidisciplinary team members and moderate technical scope in line with commercial roadmap and objectives
  • Manage and oversee vendors and consultants providing solutions
  • Leads the development and documentation of optimized business processes and change initiatives that meet business needs and support achievement of goals and objectives
  • Responsible for providing tier 2 application support for R&D applications
  • Assess, provide application solutions and recommendations to all levels of management
  • Ability to work with and manage multiple vendors
  • Author/Review Installation Qualification (IQ), Operation Qualification (OQ), and Performance qualification (PQ) documents for GxP applications
  • Participate in system validation activities and collaborate with project team on Validation Plans, User/Functional Requirements, Risk Assessments, Validation Summary Reports…. etc.
  • Ability to execute protocols, perform testing sequences and change controls
  • Test fixes and perform post-resolution follow-ups to ensure problems have been adequately resolved

Qualifications:
  • Bachelor's degree with minimum 5+ years of experience in IT/business management, with relevant experience working in pharmaceutical/biotech industry
  • Project management experience with proven adaptability to shifting project schedules, priorities and assignments; able to make effective decisions.
  • Ability to evaluate changing needs and provide accurate information based on the evaluation.
  • Knowledge and experience working within an SDLC framework and computer system validation.
  • Demonstrated experience working in a regulated environment including a thorough understanding of 21CFR Part 11.
  • Ability to analyze and define business requirements and translate into technical solutions.
  • Must have strong critical thinking and analytical skills.
  • Must possess excellent communication (oral and written) and problem-solving skills
  • Effective project management skills are essential; change management capability and desire to innovate and help lead change.

Fit with GBT culture:
  • Ability to build strong relationships with co-workers of various backgrounds and expertise
  • Ability to function at a high level in a team setting whether leading the group or acting as an individual contributor
  • Values-based leadership consistent with GBT's Core Values
  • Excitement about the vision and mission of GBT
  • Flexibility
  • Integrity

NOTE: This position summary is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization.

Global Blood Therapeutics is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to age, race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or any other characteristic protected by law.