The power of data at scale has transformed almost every industry, personalizing experiences in many aspects of our lives. Yet in healthcare we've 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.
We are seeking mission-driven, ardent, self-starting, creative individuals to join us in this effort. We are an agile organization that brings together great people who are passionate about technology innovation, and who thrive in dynamic, cross-functional, and mission-driven teams.
The IT Business Partner for PD Quality will help shape a new future of Quality in Roche and Genentech through advanced data analytics, information and technology partnering. They will lead strategies aligned to the key strategic aim of the Quality organization to bring safe personalized medicines to our patients faster by leveraging tailored safety and quality strategies that proactively prevent, detect and resolve safety and GCP quality issues, and improve the integrity of our data, so that we build Health Authority confidence in the evidence we provide.
As an Informatics Business Partner you will drive business opportunities enabled by information technology.
Responsibilities of ITBP in PDQIX:
Provide strategic direction, prioritization and mobilization of resources aligned to shared business objectives with respective areas
Actively participate in strategy setting meetings in PDQ and across informatics
Provide input into Quarterly Business Reviews and the Quality System Portfolio
Take a leadership role that educates, advises and challenges to enrich business area strategy for the benefit of the whole
Negotiate and influence to ensure the right product owners are assigned to key initiatives
Work with business, data and insights & infrastructure teams to architect, design, prototype, and develop solutions that enable quality decisions.
Lead with an agile mindset and deep understanding of what it means to have data integrity.
The Ideal Candidate:
Has business domain knowledge in Pharmaceutical and Biotech Quality, Safety, Regulatory and Global Health Authority Regulations. Nurtures and develops a business savvy consultative and value driven partnership. Champions Informatics Strategy and the implementation of core platforms. Well-networked, awareness of Group processes, cross-org perspective, connects the dots, adds the external perspective. Understands market challenges and competitive issues. Exhibits intellectual curiosity and integrity.
BA or BS in life science, informatics, business or equivalent. MA or MS and post-graduate coursework is desirable. At least 8-10 years of related experience, domain knowledge of pharmaceutical industry and manufacturing/quality assurance processes and systems, computer systems validation, GMP, FDA Part 11, etc.
5+ years business systems analysis and support experience with various types of Software Development Life Cycle methodologies.
Ability to rapidly understand business requirements and communicate business expectations to cross-functional project/delivery teams. Develop advanced technological ideas and guide their development into a final solution
Ability to lead 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 across the enterprise.
3+ years of people management or product management experience
Solid understanding of FDA, and Global Health Authority Regulations
Ability to travel up to 25%
This position is based in South San Francisco, CA and is not eligible for relocation.