Digital & Data Integrity Manager InsuLINK (all genders)

Sanofi EU; Mainz; Vor Ort; EUR 70.000 - 90.000; Vollzeit

Zusammenfassung

A leading pharmaceutical company is seeking a Data Integrity Manager to oversee Data Integrity activities for an innovative insulin project in Frankfurt. This role ensures compliance with regulations and quality standards while driving the Data Integrity strategy. Ideal candidates will hold an advanced degree in Science or Pharmacy, possess 5 years of relevant experience, and have strong knowledge of GxP regulations. Proficiency in English and German is mandatory.

Qualifikationen

• 5 years experience within Quality System Management in a health-regulated industry.
• In-depth knowledge of biologic product license applications and regulatory requirements.
• Experience with Quality systems, Quality Risk Management, and Continuous improvement management.
• Mandatory knowledge of Data Integrity.

Aufgaben

• Ensure project adherence to Sanofi Standards and report to Global Quality Project Lead.
• Drive Data Integrity Strategy and quality compliance in project execution.
• Oversee automation and computerized equipment design and validation.
• Support compliance inspections and manage preparation for audits.

Kenntnisse

Data Integrity knowledge

Quality System Management

GxP and health regulated regulations

Change management

Cooperation

Ausbildung

Advanced Degree in Science/Pharmacy or Equivalent

Jobbeschreibung

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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 !