Sanofi
pharmaceutical
QualityAssuranceOperationalSupport
Neural analysis suggests this role is
optimal for Mid candidates.
“Quality Assurance Operational Support at Sanofi. Skills: GxP oversight, process management, cross-functional coordination, vendor/stakeholder management, operational metrics, resource planning, continuous improvement. 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).. managing the required quality activities and documentation associated with th”
Industry & Context.
Excellent problem-solving abilities to address and resolve quality issues, including root cause analysis and implementation of corrective action
What They're Looking For.
Must Have
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
Nice to Have
other languages welcomed (French is an asset)
What You'll Do.
GxP oversight of a portfolio of selected Contract Manufacturing Organizations (CMOs) and business partners involved in the manufacture
and transport of Sanofi products (drug products and APIs).
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
Be the Quality representative engaged in internal core team (Supply chain
Global Quality) and joint meetings with the CMOs
Manage quality events received from CMOs
evaluate the investigation reports to assure that criticality
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
Manage the update of information related to CMOs in the Sanofi quality management system
implementing the process and the tool at local level in line with the standardized and harmonized approach
being the “Voice of Customer”
proposing evolution for simplification and harmonization of the process and the tool
How You'll Work.
Team & Collaboration
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); Be the Quality representative engaged in internal core team (Supply chain, KAM, Finance, Global Quality) and joint meetings with the CMOs; participate in CC committee; Collaborative mindset with excellent communication skills within internal organization as well as with external partners.; Work closely with global and local teams
Communication Scope
excellent communication skills
Process & Methodology
resource planning
Full Job Description
_**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
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