Quality Project Manager Prague, Praha

Quality Project Manager

_Location: Prague _
- _Hybrid_
- _ Full-time, 12 months Fixed
- term contract_
**_About the job_**:
We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families.
Your job, as **Quality Project Manager** within our External Manufacturing & Supply organization, will be to ensure that the quality projects under his/her responsibility are compliant to the Good Manufacturing Practices and current regulations, to the Quality Agreement in place and to the requirements defined in the Sanofi Global Quality Documents
The External Manufacturing & Supply (EM&S) team operates as a global virtual site and is built around different operational and support pillars. EM&S General Medicines Europe Quality & Regulatory department is the quality unit responsible for GxP oversight of Contract Manufacturing Organizations (CMOs) and business partners involved in the manufacture, testing, and transport of Sanofi products (drug products and APIs) within its portfolio.
ALMA project aims to prepare the future CMO-Customer relation between BioPharma and CHC after the separation of Opella CHC Business from Sanofi.
Within this project, EM&S Gen Med Europe will take over the management of 4 CHC sites supplying Gen Med Products and we are seeking for a Quality project manager to support the integration of those sites within our network.
**Main responsibilities**:
- Drive Quality projects implementation and rollouts in the frame of the integration of new CMOs within the team
- Review the Quality agreement for new CMOs and Product Technical specifications
- Contribute to the know-how transfer from CMOs to EM&S operationnal teams
- Manage risks identified during project
- Ensure projects are delivered on time, cost and quality
- Act as project quality manager for on-going projects related to Gen Med products manufactured at CHC Sites (e.g new API source qualification, new Equipment validation, transfer ,...)
- Be the quality representative for transfer & projects managed by the transfer team
**_ About you _**:
- **Experience**: experience of at least 2 years in Quality Assurance, on site (is a plus)
- ** Soft skills**
- Ability to work on complex projects in challenging environment
- Communication & Teamwork
- Problem-solving oriented and thoughtful risk taking mindset
- Ability to identify situations and issues which need escalation to line management
- ** Technical skills**
- Detailed knowledge of cGMP, GDP, ICH regulations and international pharmaceutical regulatory expectations
- In-depth understanding of quality management tools
- A working knowledge of conventional manufacturing operations, aseptic processing, validation principles, quality control techniques and testing methodologies of drug substances and drug products is beneficial.
- Good knowledge in lean manufacturing: SMS certification practitioner level is a plus,
- ** Education**: Master 2 level (chemist, pharmacist)
- ** Languages**: Fluent English and good Czech
**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.
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