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Informatics Business Partner Compliance

Genentech


Location:
South San Francisco, CA 94080
Date:
07/22/2020
2020-07-222020-12-04
Categories:
  • Healthcare
  • Business
  • Financial Services
  • Manufacturing / Production
  • Marketing
Genentech
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Job Details

Product Development Informatics Quality, PDIXQ

The power of data at scale has transformed almost every industry, personalizing experiences in many aspects of our lives. Yet in healthcare, weve only scratched the surface. At Genentech and Roche, we are accelerating the use of data insights and digital technologies to make significant strides to reach the full potential of personalized healthcare.

As a Compliance IT Business Partner, you will join our diverse informatics community of smart, fun, wholehearted, and engaged professionals from various functional areas. You will share our community values of passion, courage, integrity, and gratitude -- all in service of our mission, doing now what patients need next.

Your primary accountability is to provide quality leadership. By being embedded in Product Development strategy teams you develop a deep understanding of safety, clinical, and medical data challenges and opportunities. You will drive the design, creation, and adoption of novel validation strategies needed for advanced technologies. You ensure data integrity and patient confidentiality while taking measured risks to bring speed to the product development lifecycle. You act as a bridge between technology and compliance groups.

As the Compliance Business Partner, you will establish strong relationships and manage stakeholders across the globe. You are someone who can negotiate, influence, and lead at all levels.

Responsibilities of a Compliance ITBP in PDQIX include:

  • Able to articulate and facilitate the understanding of a systems intended use and its compliance risk profile.
  • Risk-based identification and classification of GXP systems
  • Guide software project and product teams in understanding their role in establishing and maintaining the compliance of critical systems.
  • Drive quality simplification and transparency across the organization
  • Have expert-level knowledge of SDLC lifecycle methodologies, including agile, and be able to apply agile to compliance topics.
  • Review & approve system risk assessments (SRA)
  • Advise advanced analytics data groups on future compliance trends
  • Serve as a point of escalation to executive leadership and PDQ for quality and compliance issues related to high-risk systems.
  • Leverage the technical expertise of the internal teams and external technology providers and vendors to deeply understand the picture and risk.
  • Manage vendor risk
  • Engage with Procurement on acquisitions and assess compliance against internal expectation and SOPs
  • Assess outsourced vendors and clinical suppliers.
  • Oversee data classification and privacy for all PD systems
  • Serve as a single point of contact for PDIX on audit and inspection
  • Maintain expert-level knowledge of the dynamic health authority governance; inclusive of GDPR, HIPAA, SaMD, 21CFR part 11.

The Ideal Candidate:

Has a diverse background. Has managed change in the most trying of times. Is a fixer and a solver. Wants to tackle the biggest healthcare challenges that face us globally in the 21st century.

They excel at relationship building and networking. Have demonstrated the ability to navigate complexity, is pragmatic, sees the big picture!

The ideal candidate can demonstrate through experience making an impact in a large global and matrixed organization.

Qualifications:

  • BA or BS in life science, informatics, business or equivalent. MA or MS and post-graduate coursework is desirable.
  • At least 10 years of related experience, domain knowledge of the pharmaceutical industry and manufacturing/quality assurance processes and systems, computer systems validation, GXP, FDA Part 11, HIPPA, SaMD, Data Privacy
  • 3+ years in a technology role IT or Data
  • Program or IT Product management experience
  • Expert knowledge of Software Development Life Cycle methodologies, inclusive of Agile.
  • Experience leading cross-functional collaborative team environments, provide innovative solutions to complex business problems and make decisions with cross-functional impact
  • Strong English and German communication skills (nice to have) -- ability to communicate complex information, issues, and potential solutions at an executive level.
  • Ability to travel up to 25%

#LI-RA

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