Senior Manager, IT - GxP Applications

Atreca

South San Francisco, CA, US
  • Job Type: Full-Time
  • Function: IT
  • Post Date: 02/20/2021
  • Website: atreca.com
  • Company Address: 75 Shoreway Road, Suite C, San Carlos, CA, 94070-2727

About Atreca

Atreca is a biotechnology company that develops novel therapeutics through a deep understanding of the human immune response, with a focus on innovative novel cancer immunotherapeutics. With its Immune Repertoire Capture™ (IRC™) technology, Atreca has an unparalleled insight into how cancer patients’ immune responses can drive better clinical outcomes. Atreca was founded by scientists, industry experts, and investors who share the vision that unlocking the immune response of today’s patients is the key to creating a new generation of therapies.

Job Description

Atreca is an integrated biotechnology company located in South San Francisco, California (moving in 2021 to a new campus in San Carlos, CA). We apply our proprietary drug discovery platform to profile clinically relevant, active B cell responses in patients receiving successful treatment and, in turn, develop a portfolio of antibody therapeutics against novel tumor targets with the potential to treat large patient populations. Atreca seeks talented, driven individuals who are dedicated to making a positive impact on human health and are motivated to become key members of a growing biotechnology company.

Position Summary

Reporting to the Director of IT, the Senior Manager, GxP Applications will partner with business leaders to align IT GxP efforts with business requirements. Engage client leadership and IT to ensure that all GxP technology, architecture, and governance are aligned to strategic business initiatives.

Duties and Responsibilities

  • Provide strong understanding of business core functions and compliance needs while considering short and long-term strategy
  • Provides guidance and counsel on technology available that drives delivery of compliance solutions consistent with business direction
  • Manage technology investments to align with IT compliance architecture and roadmap in partnership with the business.
  • Collaborate with Legal and Compliance departments in development and implementation of compliance initiatives
  • Lead / manage internal and external resources in support of business-related projects and activities.
  • Collect and analyze business requirements, design, and document workflow of data between systems to enable an efficient, automated, and easily managed GxP environment
  • Develop functional specifications to support systems and business process design that align with the IT Strategic plan
  • Collaborate with business functions and technical team through the development and testing of solutions such as screen, interface and GUI designs; ensure all approved requirements are met.
  • Facilitate the evaluation and selection of new applications and functions and determine issues in services and software
  • Represent IT during inspections and audits.
  • Document GxP processes and procedures
  • Lead system validation process
  • create SOP’s for compliance and validation

Required Skills and Qualifications

  • Bachelor's degree in Business, Computer Science or Information Systems
  • Master’s in Business is a plus.
  • 10+ years of experience in IT building and supporting enterprise applications
  • Strong business knowledge and ability to operate as the IT applications SME
  • Knowledge and experience working within an SDLC framework
  • Public company experience including working in a regulated SOX environment
  • Prior experience working in the Life Science industry including pharmaceutical, biotechnology or medical device required
  • Ability to analyze and define business requirements and translate into technical solutions.?
  • Effective project management skills are essential; change management capability and desire to innovate and help lead change.
  • 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.
  • Experience with the following system types/platforms preferred: CTMS, eTMF, SAS, Data warehouse, BI, Safety, QMS, and EDMS

Special Skills / Knowledge:

  • Strong written and oral communication skills
  • Strong presentation and interpersonal skills
  • Exceptional analytical, conceptual and problem-solving abilities
  • Able to prioritize and execute tasks in a high-pressure environment
  • Exercise judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results
  • Excellent organizational skills and the ability to balance several on-going projects simultaneously
  • Ability to communicate ideas in both technical and user-friendly language.
  • Experience working in a team-oriented, collaborative environment
  • Working knowledge with CFR 21 Part 11, GxP Validated Systems, and Sarbanes-Oxley Regulations
  • Experience administrating and working with Master Control QMS platform

Exact title commensurate with experience. Atreca is an equal opportunity employer.

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Disclaimer: Local Candidates Only
This company does NOT accept candidates from outside recruiting firms. Agency contacts are not welcome.