Quality Assurance Operational Support

Quality Assurance Operational Support

• Location: Prague, Czechia

• Hiring Manager: Martin Kabátek

About the job

The position belongs to the External Manufacturing & Supply (EM&S) General Medicines Europe team which operates as a global virtual site. As a member of the team, you will be responsible for GxP oversight of a portfolio of selected Contract Manufacturing Organizations (CMOs) and business partners involved in the manufacture, testing, and transport of Sanofi products (drug products and APIs). You will communicate and interact with functional units within EM&S, Sanofi sites, and other organizations within the Manufacturing & Supply network (e.g., Global Quality, Procurement, Supply chain, Finance) to ensure compliance with internal and regulatory requirements for products within your allocated portfolio.

Main responsibilities

You will be responsible for managing the required quality activities and documentation associated with the portfolio of CMOs, ensuring that the CMOs manufacture and deliver products in compliance with Sanofi’s requirements, specifications and regulations applicable for pharmaceutical industry

This includes the following :

●        Be the Quality representative engaged in internal core team (Supply chain, KAM, Finance, Global Quality) and joint meetings with the CMOs

●        Manage quality events received from CMOs, evaluate the investigation reports to assure that criticality, root cause, impacts if any and CAPA are properly addressed and verified

●        Evaluate the CMOs decisions regarding the final disposition of the impacted batch(es) and confirm the Sanofi decision to the CMOs

●        Manage internal quality events and quality alerts related to a quality event, like OOS results in IPC/FP quality control, stability study testing and other as defined in Sanofi QMS

●        Manage and evaluate Change Controls as a quality expert, participate in CC committee and ensure a timely closure following the implementation and effectiveness check

●        Review and update the Quality Agreements with the CMOs or Business partner, ensuring compliance of Manufacturing & Supply activities delegated to CMOs

●        Provide support to the CMO during regulatory inspections, when requested

●        Manage the update of information related to CMOs in the Sanofi quality management system

●        CMO Quality manager position is also SME (Subject Matter Expert) and member of the Community of Practice for some Quality processes. As member of the Community of practice, you will be:

o accountable for implementing the process and the tool at local level in line with the standardized and harmonized approach, including training, communication, end user support, change management, as appropriate.

o responsible for being the “Voice of Customer”, proposing evolution for simplification and harmonization of the process and the tool

About you

●        ​Minimum 5 years of experience working in a cGxP or other regulated environment for biotechnology/aseptic pharmaceutical products in an on-site Quality or Production role.

●        Having the experience with pharmaceutical regulation, good practises and its application within whole product lifecycle from the material supply till market entry

●        Excellent problem-solving abilities to address and resolve quality issues, including root cause analysis and implementation of corrective action

●        Demonstrated ability to perform work that requires independent decision making and the exercise of independent judgment and discretion

●        Collaborative mindset with excellent communication skills within internal organization as well as with external partners.

●        English spoken and written compulsory, with other languages welcomed (French is an asset)

About Sanofi

We’re an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system – and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people’s lives.

Why choose us?

· Join a leading pharmaceutical company and contribute to improving health outcomes worldwide.

· Be part of a company at the forefront of medical research and breakthrough therapies.

· Thrive in an environment that values diversity of thought and background.

· Work closely with global and local teams, gaining exposure to various aspects of the pharmaceutical business.

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