Quality Risk Champion

Job description

Job Description

·  As part of Quality Systems Organization, ensure effective implementation of Quality Systems across the site.
·  Responsible to manage overall Quality Risk Management process across the site.
·  Responsible to efficiently integrate risk management principles into quality systems across site quality procedures.
·  Ability to effectively manage proactive risks, reactive risks and emerging risks in line with Global guidelines.
·  Anticipate and identify to raise proactive risks in line with applicable Global Quality process.
·  Responsible to develop site risk master plan and its execution within defined time frame.
·  Ability to effectively coordinate with Risk Facilitators for assessment of raised quality risks.
·  Expertise in tools and techniques of Quality Risk Management as FMEA, HACCP etc.
·  Expertise to lead investigations and execute CAPA plans as a result of identified quality risks.
·  Evolve and facilitate the site risk assessment process to create efficient and robust site risk profile.
·  Coordinating activities related to escalation and management of reactive risks, Quality Alerts, Risk Investigations and Risk Reports.
·  Coordinate and facilitate complex cross site or  cross-product risk management programs as and when appropriate.
·  Conduct Quality Risk Management meetings with cross functions at defined frequency
·  Maintain Site Risk Register and coordinate to update on defined frequencies.
·  Support the development of the Quality Risk Management training program to promote a culture of quality risk management.
·  Manage and monitor implementation of the Global Quality Procedures when applicable.
·  Drive the culture shift from reactive to proactive quality risk management.
·  Responsible to drive Quality Culture Program and Quality transformation initiatives across the site.
·  Strong ability to influence and adapt so as to identify and impart GXP Training needs across the site.
·  Support in development and deployment of annual GXP Training Plan.
·  Digital mindset with the ability to leverage digital tools and techniques for GXP trainings.
·  Good presentation skills with ability to conduct effective trainings on Quality Systems.
·  In depth understanding of GXP Quality Systems and Regulatory requirements.
·  Well versed with concepts of Qualification and Validation and support as required.
·  Thorough understanding of Pharmaceutical Water Systems and Utilities at site
·  Thorough understanding of Manufacturing, Packaging, Warehouse and Laboratory procedures.
·  Strong Quality mindset with the ability to drive Quality Culture across the site.
·  Team player with proven ability to effectively work with cross functional teams.
·  Innovative approach to identify and execute Quality Improvement Projects at site.

Education:

·  Pharmacist (Pharm. D / B. Pharm)
·  Chemist / Microbiologist / Biotechnologist with relevant experience.

Lead competencies

·  Act for Change
·  Cooperate Transversally

Experience:

·  05 years of relevant experience in Quality Operations or Production

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.