Job Description :Mission
Vaccines Industrial Affaires (VIA) is preparing its future through an ambitious program named Evolutive Vaccine Facility (EVF). The EVF Project is at the cornerstone of Sanofi Pasteur 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 and digital, to better address vaccine business challenges. Quality will be one of the key topics to help EVF to reach its ambition. In this context, we are looking for one EVF SGP QUALITY HEAD for one of our EVF sites based in Singapore.Main missions are:
- Fully responsible to implement Quality organization and management system on a new greenfield site based in Singapore, site according to EVF project strategy and key milestones. It should include, but it is not limited to quality assurance, quality control, GMP certification and compliance management.
- Fully responsible for the construction of quality team and ensure that future operating model and quality management meet GMP requirements before 1st GMP activities.
The mission described below, must be exercised in compliance with health, safety and environment of the site rules.
-Ensure the role of EVF project quality leader in Singapore by delegation from the centralized organization based in France to support locally new EVF site implementation;
- Co-design, oversight and insure implementation of Validation Plan according to Master Plan related to Holistic Control Strategy framework
- Interact constanly with the EVF Quality Team and the EVF Digital Leader in identifying and formalizing the specific quality needs and requirements (Authenticity of records and data, Data Integrity rules, back-up solutions…)
- Support all the GMP activity for risk-based approach exercises that are needed for the project and to guarantee compliance in terms of methodology and execution. Implement a quality risk Management for the site (identify risks, define and implement the appropriate mitigation/remediation plans in an iterative way…)
- Be responsible for the human resources and organization arrangement to put in place the appropriate workforce for quality assurance, quality control and product release departments with the appropriate skills to deal with EVF operating model
- Ensure all prerequisites are in place to obtain GMP certification and all necessary inspections are completed to operate EVF following schedule to start GMP activities, cooperate with the appropriate Health Authorities (HAS…) when needed; Ensure that the inspection of all activities including raw materials, incoming materials, outsoursing activities (e.g. testing, storage…) is in use.
- Support the EVF Project Core Team in case of Health Authorities communication.
Once GMP activities started (CQ&V), ensure that the site is in full compliance with the applicable regulations in a sustainable and consistent way for guaranteeing that manufactured product are of the appropriate quality and safety prior to the product release. Ensure that quality systems and cGMP compliance are properly implemented and strictly adhered to in an efficient and compliant manner in order to guarantee product availability for market release in a timely manner and cost effective way.
In addition to specified by Singapore laws and local regulations:
Scope and dimensionsBreadth of responsibility (global/regional/country/site):
- Be responsible for vaccine drug substance and clinical batches production of the company independently, supervising the implementation of cGMP, ensuring suitable in-process control and quality control to guarantee the compliance of drugs with standards and durg registration specifications;
- Timely report any major safety events related to drug quality and carry out risk management to ensure risks are timely controlled. Participate in quality risk management (QRM), product recall decision making, adverse drug reaction report and other related quality activities.
- Be responsible for reviewing and approving all quality related documents and changes in consistency with the global EVF quality organization, and ensuring that all deviations and OOS/OOT results are investigated and processed in a timely manner. Ensure all product quality audit and product quality review analysis.
- Regularly carry out quality audits of related parties including manufactures and suppliers to encure regulatory compliance.
- Be responsible for the human resources, budget and organization arrangement to ensure the performance for quality assurance, quality control and product release departments.
- Ensure the consistency of practices between EVF based in Singapore, Neuville sur Soane and the project organization with Sanofi Guidelines. Ensure Continuous Quality Improvement, taking into account lessons learned from EVF network and from the Group.
- Ensure that new employes receive necessary training when they enter the company, especially for QC, QA and related employees of the company to receive necessary training on a regular basis to maintain there qualification status
- Supervise the maintenance of plant facilities to keep them in good working condition, same for sanitary environment of the factory; monitor all factors affecting product quality.
- Supervise regular Health Authorities inspection and internal or external audits
Position based in Singapore Site
Health Authorities environment: Singapore, Europe, US, Canada, Japan, China, Brazil, Mexico, WHO, ...
Potential trips abroadKey dimensions: headcount (direct and indirect), budget, doses, Capex
Largest Program (> 800 M€). Large impact on innovation SP ambition. Extensive scope and complexity; effective cross-functional interaction, global networking, communication & change management.Key indicators and which the job holder will be evaluated (WHAT in 9box…):
- Performance on all Quality systems.
- Validation plan defined and executed.
- Respect of deadlines and commitments
- Management of the activity and indicators at the right level of performance.Freedom to act, level of autonomy:
Decision making on activities (suspension / go/no go for the project).
Quality Risk assessment and implementation of risk reduction plans.
Proposal for a quality decision in case of roadblocks.Education and experienceSpecific degree, duration of experience (Required to hold the job):
Pharmacist, Scientist or Engineer with about 15 years of experience in the pharmaceutical or biotechnology industry with high level of responsibilities.Key competencies:
Customer Focus, Act for change, cooperate transversally, Results driven.Key technical competencies and soft skills:
- Manufacturing 4.0 mindset (Agile methodology…)
- Knowledge of regulations and standards of the pharmaceutical industry, Global Quality policies and Data Integrity Requirements.
- Knowledge of the systems and technologies of the covered sector.
- Strong 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 of digital validation strategy.
- Ability to innovate / think out of the box
- Good communication skills in order to advocate Quality positions on QRM, Innovation and New Technologies when meeting with Health Authorities, including inspections
- Fluent in English speaking and writing
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.