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.
Your responsibilities include:
Articulate and facilitate the understanding of a system’s intended use and it’s compliance risk profile
Oversee and provide guidance and consultancy on Information governance and compliance topics
Information lifecycle review , retention management, disposal management, legal hold, metadata standards, data sharing principles, data privacy (SCC's, Privacy Shield, Data location), vendor qualification / audit, manager vendor risk and platform SRA/DCR (boundaries to projects, common elements, alignment)
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 life cycle 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
Engage with Procurement on acquisitions and assess compliance against internal expectation and SOPs’ and assess outsourced vendors and clinical suppliers.
Oversee data classification and privacy for all PD systems and 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.
Who you are:
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, be pragmatic, and prioritize!
As ideal candidate you have a BA or BS in life science, informatics, business or equivalent. MA or MS and post-graduate coursework is desirable. Further more you bring 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.
Your further qualifications:
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%
Roche embraces diversity and equal opportunity in a serious way. We are committed to building a team that represents a variety of backgrounds, perspectives, and skills. The more inclusive we are, the better our work will be.
If you still have questions then please check our FAQs and videos on careers.roche.ch/faq.