Expert II, Quality Governance and Inspection Readiness, EVF
Sanofi
Singapore
Permanent
Full-time
2 months ago
MissionSanofi Vaccines Industrial Affaires (VIA) is preparing its future through an ambitious program named Evolutive Facility (EVF). The EVF Project is at the cornerstone of Sanofi strategy as it aims at creating a new manufacturing concept consisting of a new generation of evolutive multi-product facilities, modular, adaptable and agile, leveraging new disruptive technologies, to better address business challenges. Digital will be one of the key topics to help EVF to reach its ambition. On top of it, VIA is also embarked with the ambition to leapfrog the competition through a digital acceleration program with the following vision: “VIA will fully integrate Digital capabilities & culture within its operations to boost business growth and profitability in 2025+”.In this context, we are looking for one Quality Expert, Quality Governance & Inspection Readiness for our new site based in Singapore.Key AccountabilitiesThe Quality Systems (QS) sub-team is under the remit of the Site Quality Department, and is responsible for the quality system management (QMS) implementation and maintenance within the site. The QS sub-team is responsible for setting up or reviewing and auditing the quality management systems, which is instrumental in ensuring the site systems and processes meet the international and Sanofi GxP requirements.The QA Expert (Quality Governance & Inspection Readiness) sits in the Quality System sub-team, and is directly responsible for monitoring the effectiveness of the site quality system, administering the site quality metrics and ensuring the site is ready for corporate, customer and regulatory inspection.The mission described below, must be exercised in compliance with health, safety and environment of the site rules.Responsible for assessing the effectiveness of the site Quality System with suitable metrics on an annual basis. Propose and administer the appropriate lag and lead indicators of a good quality management system.Lead the site monthly quality council meetings, ensuring the meetings are effective in uncovering a reliable insight to the site quality performance and culture, areas of improvement and areas of good practice. Share good quality improvement initiatives with other sites in the network.Highlight any risk in the site quality management system, and work with the site quality risk expert to escalate and manage the risk.Develop and lead the implementation of a robust site self-inspection program, ensuring the program effectively uncovers risk of non-compliance to regulatory and corporate requirements. The program should also highlight good practices to be implement for the rest of the site and to be shared with other sites in the network.Lead the site internal audits. The internal audits will independently assess the effectiveness of the entire site and functional management principles, and GMP processes and control, to drive remediation of the gaps and leverage on opportunities observed.Drive the site inspection readiness program and ensure effective co-ordination and support for external and internal audits for the site.Have a good appreciation of the global regulatory inspection trends and areas of focus by the regulatory agencies, and to share these with the rest of the site and feeding the information into the site internal audit program to prepare the site for regulatory audits.Work with all Functional Representatives to ensure the functions are always audit ready, and train and prepare the site personnel on fronting customer and regulatory audit inspectors.Review and support of audit (internal, corporate and external) observations. Supports timely development and closure of internal and external audit responses and CAPAs.Manage the budgets for inspection readiness preparation.Education and experienceBachelor’s or Master’s Degree in Sciences, engineering or other related technical field.Minimum 8 years of relevant experiences preferably in Manufacturing, Validation, Quality in the pharmaceutical or biotechnology industry (with preference in vaccines and/or biologics).Prior certification as a company GMP auditor.Key technical competencies and soft skills:Solid knowledge of regulations and standards of the pharmaceutical industry, Global Quality policies and data integrity requirementsSolid knowledge of Quality Management Systems and associated technologies, with demonstrated past success to lead QMS processes implementations.Strong Project Leadership skills driving compliance and accountability. Have experience managing medium to large scale site wide projectsStrong interpersonal relationships in order to establish the partnerships necessary for the development of the Quality culture and the correct execution in transverse.Discipline and assertiveness in the decision-making and execution.Good communication skills in order to advocate site positions with the global quality organisationsGood understanding of risk-based decision frameworkFluent in English speaking and writingAbility to gown and gain entry to manufacturing, QC and Engineering areasSound practitioner of Manufacturing 4.0 mindset (or equivalent Lean or Agile methodology)Experienced in start-ups will be advantageousAt 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.
