The Position
At Roche, 94,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups.
Our success is built on innovation, curiosity, and diversity. We believe every employee makes a difference. We are passionate about transforming patients’ lives.
We are courageous in both decision and action, we believe that good business means a better world.
Job Summary
Orchestration and Exception Management (O&EM) is a new and fundamental capability for Technical Operations (PT) in order to deliver a future portfolio of Cell & Gene Therapy (CGT) products.
This portfolio of new products comes with the great promise to bring unprecedented medical advances to patients but also presents unique challenges : living products cells) need to be delivered to patients in highly individualized supply chain models, which meet fast turn-around-times at a zero-error quality level.
Orchestration and Exceptions Management is one of three end-to-end value chain groups, responsible for the virtual treatment journey (data, transactions and documents).
It is complementary to supply chain management that focuses on the physical journey (materials, specimens, product) and patient operations, responsible for the patient journey .
As the CGT Master Data Management Domain Expert you will be shaping the future of CGT at Roche, by helping to address key MDM challenges.
You will be part of the CGT MDM team in O&EM and will contribute to the evolution and growth of the capability from being able to support first late-stage clinical trials to being able to support a full portfolio of various CGT modalities in clinical and commercial stages.
You will bring your passion and many skills to the table including the ability to autonomously drive complex MDM topics, your delivery oriented ways of working, your strong collaboration skills.
Key Responsibilities & Job Requirements
The CGT Master Data Management Domain Expert will
Help in enabling a master data management strategy and MDM principles for the CGT business unit (PTC), which is vital for the successful management of virtual treatment journeys (data, transactions, documents)
Autonomously drive specific domain work packages, to translate the strategy into action and results in the respective domains.
Capability Development
Help to design MDM functionality within two co-innovation solutions - Treatment Center Platform (TCP) and a Treatment Management Platform (TMP) to ensure first-time-right , capture at source , compliant and fast data maintenance.
Own and drive specific design work packages related to domains for the design of the Treatment Center Platform and the Treatment Management Platform (TMP)
Assess and propose solutions for specific MDM challenges
Own and drive MDM roadmap items related to domain across systems, governance, process, people and data culture
Data Stewardship
Drive work and coordinate activities to ensure data readiness of the O&EM platform as well as ERP systems, closely collaborating with other relevant stakeholders.
Act as data steward for relevant MD, being involved in day to day operations and support activities.
Work closely with CGT product teams, CGT O&EM Operations, other E2E value chain teams, local CGT stakeholders in the relevant sites (HIT, Penzberg, Mannheim) as well as other MDM functions to ensure data readiness for the E2E value chain.
Ensure high quality and timely availability of data and own their Domain (logical) Data Model
Stakeholder Management
Help to establish a network of CGT MD relevant internal stakeholder
Ensure and facilitate regular alignment of operational teams that are involved in CGT relevant MDM procedures (Create, Read, Update, Delete)
Who You Are
Qualifications, Experience & Education
Bachelor's degree, or equivalent academic qualification ideally with focus on Supply Chain / Value Chain Management, or Enterprise Information Management preferred
At least 5 years of work experience with extensive knowledge in Master Data Management in pharma, ideally several years in CGT.
MD maintenance and governance work experience as Master Data Steward, Business Analyst or Expert preferred.
Experience related to virtual treatment journey (Data, Transactions, Documents) in complex and large organization(s)
Proven track record of working with agile teams SAFe, SCRUM, Design Thinking)
Experience working with SAP ERP SAP ECC / S4HANA) and SAP MDM technology SAP MDG), data quality tools IDQ) and / or ETL tools
Knowledge and understanding of CGT MDM challenges and solution within clinical and commercial pharma;
Project experience as a role contributing to designing, testing and rolling out MDM functionality for validated systems.
Good understanding of regulatory requirements related to data GDPR, HIPAA, GxP Annex 11, CFR 21 part 11, specific regulations for ATMPs around CoC / CoI)
Be willing / able to travel Internationaly up to 10%
Relocation benefits are approved for this posting.
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