Digital & Data Integrity Manager InsuLINK (all genders) (m/w/d)

60311 Frankfurt am Main

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About the job
Be part of a once-in-a-generation project that's shaping the future of insulin.
Sanofi is building a cutting-edge, fully automated insulin drug substance facility in Frankfurt - a bold investment that builds on our legacy of excellence in insulin manufacturing. This sustainable, next-gen biologics site will support the entire portfolio of insulins, from development to delivery.
Join us at the forefront of this global transformation. As part of a cross-functional program team, you'll help bring this facility to life - from early design and construction through to readiness for commercial manufacturing. Your work will help turn the miracles of science into reality for millions living with diabetes.
Meet Katrin, our Global Insulin Program Leader, and see how we're reimagining insulin production. Watch now!
Position Overview
The Data Integrity Manager InsuLINK is responsible for ensuring that all aspects of Data Integrity activities for the project are executed on time and in accordance with the project, local and global requirements, and applicable regulations.
As an integral part of the project quality team, this position has overall responsibility for participating in project workstreams, ensuring proper execution of qualification/validation strategies, implementation of data integrity in InsuLINK as well as providing support and guidance for quality processes and procedures.
This role is expected to work independently and with a level of autonomy and authority in decision-making to ensure on-going compliance against approved documents and current Good Manufacturing Practices across the project during conceptional, basic and detailed design, construction C&Q, PQ, Validation and future site organizations until final approval.
Main responsibilities:

Ensure the project is performed according to the Sanofi Standards and Good Practices and report regularly to the Global Quality Project Lead
Responsible for the project Data Integrity strategy; act as Quality Subject Matter Expert (SME) for the project on all matters related to Data Integrity and assuring quality compliance in project execution
Responsible to drive Data Integrity Strategy in InsuLINK in collaboration with Automation, MSAT, Operations and CQ team, with focus on data integrity in GxP alarms, electronic Batch release, Quality data proc CS, Data Integrity & VEX in InsuLINK.
Deliver Quality activities in accordance with InsuLINK planning & project needs, including writing, reviewing and releasing documentation as required
Oversee as Quality the Strategy and Execution of Automation and computerized Equipment Design, Automation C&Q and integration in C&Q&V, code testing, integration and documentation by external vendors.
Supporting the review/approval of validation protocols and final reports (IQ, OQ, nP-PQ, PPQ, IPV, IPV, etc.)
Interacts with IFB to keep benchmark and best practices cross-fertilization.
Project Control, Cost & Schedule:
Supporti the regular collection of actual quality Data Integrity cost and progress.
Support of all relevant compliance inspections (e.g., Internal audits, Global Audits, Health Canada, FDA, HLfGP), and customer compliance inspection activities. This includes the responsibility of pre-inspection preparations, coordination of activities, participation in post-inspection responses, follow-ups, and the assurance of inspection reports to appropriate management personnel

About you

Education/Experience: advanced Degree in Science/Pharmacy or Equivalent; 5 years experience within Quality System Management in Health regulated industry; Data Integrity knowledge absolutely mandatory
Soft and technical skills: Act for Change, cooperate transversally; In-depth knowledge of the biologic product license application process, and the associated regulatory requirements; Experience with Quality systems, Quality Risk Management, Continuous improvement management, GxP and health regulated regulations, International and FDA exposure
Languages: English & German mandatory, French as a benefit

Pursue Progress. Discover Extraordinary.
Progress doesn't happen without people - people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. You can be one of those people. Chasing change, embracing new ideas and exploring all the opportunities we have to offer. Let's pursue progress. And let's discover extraordinary together.
At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity.
Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!
Diversity und Inklusion sind in den Grundwerten von Sanofi verankert und spiegeln sich in unserer Arbeitsweise wider. Wir respektieren die Vielfalt unserer Belegschaft in Hinsicht auf ihre Herkunft, Erfahrungen und Lebensweisen. Wir erkennen die Bereicherung, die diese Vielfalt birgt, und fördern Inklusion sowie eine Arbeitsumgebung, in der diese Unterschiede sich weiter entwickeln können, zur Stärkung des Lebens unserer Mitarbeiter, Patienten und Kunden.

Sanofi-Aventis Deutschland GmbH

60311 Frankfurt am Main

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