Manager IT R&D Solutions

Location
San Francisco, CA, United States
Posted
Apr 25, 2021
Ref
1050
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
MANAGER, IT R&D SOLUTIONS

Position Summary:

The Manager, IT R&D Solutions role will collaborate closely with IT Business Analyst, project managers, CSV Lead, and vendor partners to deliver validated IT solutions across a dynamic and growing biotechnology company. The role is responsible for deploying, configuring, implementing validated technology systems; acting as subject matter expert where appropriate; and providing ongoing process and enhancement support post-implementation for Veeva Vault and other GxP Systems.

The ideal candidate has a solid technical background, is well organized, independent and possesses a "can-do" attitude. They must understand the importance of excellent customer service via collaboration and partnership with colleagues in the development organization. This position will support GxP systems across multiple departments such as Clinical, Quality Assurance, Supply Chain, Regulatory, Biometrics...etc.

Essential Duties and Responsibilities:

  • Responsible for providing tier 2 application support Veeva QualityDocs, QMS,
  • Support system releases and enhancements to existing applications by providing technical expertise
  • Test fixes and perform post-resolution follow-ups to ensure problems have been adequately resolved
  • Perform change management activities, and oversee documentation of configuration and design specifications
  • Configure and manage integrations to Vault platform as needed
  • Partner with IT Business Analyst to identify gaps between business needs and technical capabilities; work to find innovative solutions that meet business objectives
  • Author and refine system support processes, flow diagrams, configurations, and interdependencies
  • Ability to work with and manage multiple vendors and managed services providers
  • Assess, provide application solutions and recommendations to all levels of management
  • Participate in system validation activities and collaborate with team members on Validation Plans, User/Functional Requirements, Risk Assessments, Performance Qualification/UAT, Validation Summary Reports….etc.
  • Provide support and Subject Matter Expertise related to GxP Systems during internal audits or regulatory inspections


Qualifications:

  • Bachelor's degree with minimum 5+ years of experience in IT/systems management, with relevant experience working in pharmaceutical/biotech industry
  • 5+ years of experience in implementing GxP solutions and application management through various product cycles and business environments
  • Experience administering the Veeva Vault Platform, QMS, eTMF, QualityDocs, and RIM is required
  • Prior experience working in the Life Science industry including pharmaceutical, biotechnology
  • Familiarity with GxP and ICH regulations and 21CFR, Part 11
  • Excellent organizational, interpersonal and customer service skills; excellent communicator with active-listening skills
  • Proven adaptability to shifting project schedules, priorities and assignments; able to make effective decisions under pressure
  • Demonstrated problem-solver in a dynamic, fast-growing team environment.
  • Highly motivated with the ability to drive results


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.

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