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Global Quality System Process Manager

Synthorx

Synthorx

Quality Assurance
Multiple locations
Posted on Tuesday, January 9, 2024

JOB PURPOSE

The purpose of the Global Quality System & Process Manager position is to define and maintain the Global Quality System for pharmacovigilance (PV) in compliance with legal obligations and regulations for global, regional and local teams.

He/she will be responsible of a wholistic Quality System that includes:

  • Ensuring a sustainable compliant and robust Quality Management System (QMS) meeting Good Pharmacovigilance Practices (GVP), regulatory and legal requirements
  • Creates, enables and maintains a QMS which mandates from global to country level a state of control on monitoring and tracking systems with regards to pharmacovigilance activities
  • Identifies potential risks of non-compliance and establishes and oversees improvement programs to mitigate the risks
  • Ensures that the PV organization is inspection-ready and supports preparation, conduct and follow-up of inspections and audits

KEY ACCOUNTABILITIES

  • Preparation and maintenance of Global Quality documents (QDs) applicable for CHC PV architecture in line with global quality directives and standards.
  • Definition of the planning and execution of QD plans and QD lifecycle management (updates and periodic reviews)
  • Make Quality documents available in timely manner in the Electronic Document Management System
  • Management of Quality Events in the Electronic Quality Management System (i.e. deviation, CAPA, change control) in a timely manner
  • Ensure process is in place to maintain the PV QD Training Matrix, training curriculum updated.
  • Ensure global traceability and monitoring of investigations of all identified quality gaps, quality risks and ensure that Corrective and preventive Action Plans are implemented in timely manner.
  • Conduct or coordinate Quality Risk Management analysis, reporting and eventually, escalation and ensure appropriate and adequate traceability and documentation of quality risks.
  • Perform trend analysis on quality audits results and deviations and analyze effectiveness of corrective/preventative action and re-adjust the measure.
  • Coordinate/ lead vendor qualification standards and processes to track vendor assessments and oversee the level of quality of their deliverables.

ABOUT YOU

  • Bachelor’s or master’s degree in life/ medical/ natural sciences or scientific discipline or equivalent
  • Minimum of at least 5 years’ experience in the pharmaceutical industry with at least 2 years’ experience in GVP quality operations-related roles
  • Knowledge of international regulations/Guidelines/Good Practices pertaining to the ICH-GxP
  • Demonstrated ability to lead complex projects/ assignments.
  • Experience in Audits and Inspection Management
  • Capability to work under extreme pressure
  • Excellent communication skills (oral and written)
  • Experience in pharmacovigilance and/or Clinical Operations in the field of PV or clinical inspections
  • Excellent organizational and planning capabilities
  • Ability to work in transversal/cross functional teams
  • Excellent teamwork and interpersonal skills
  • Organized and detail oriented, efficient time management
  • Analytic, pro-active and effective problem-solving skills
  • Fluent spoken and written English, an Additional language is desirable

If the description fits your experience and has captured your interest, please apply so we can get in contact with you!

Discover our Code of Conduct, that serves as the moral compass that guides us when chasing the miracles of science to improve people’s lives. Please ensure to have read this document, before applying.

Better is out there. Better medications, better outcomes, better science. But 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. So, let’s be those people.

At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity.

Pursue Progress. Discover Extraordinary.

Visit our external career site for more opportunities and information:

https://www.sanofi.hu/hu/karrier

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At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.

At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.