Quality Lead, Hong Kong and Taiwan

About the job

We’re an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system – and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people’s lives.

Quality makes sure that safe and reliable products & services are available within Taiwan and Hong Kong to meet the healthcare needs of our patients and customers. Our team ensures that a consistent & effective quality system for GxP and health-regulated activities is implemented in Pharmacovigilance, Clinical Operations, Medical, Regulatory Affairs, Business Units, and Business Partners in compliance with the Global Quality Policy, company quality standards and local regulations.

Main responsibilities:

1. Management of the Country Quality system

• Define, implement, manage and control a Country Quality system for GxP and health-regulated activities from development to commercialisation of all products and related GxP services, in compliance with Sanofi quality documents and standards, as well as applicable local regulatory requirements
• Enhance Quality culture & promote Quality mindset into the country governance, working principles and ways of operating
• Ensure appropriate communication of key messages pertaining to quality across the country organisation, highlighting their possible business impact
• Lead and coordinate a network of professionals designated in each country function involved in GxP and health-regulated activities and embark them to address all matters related to quality
• Assure that a process for management of GxP documents and records is in place in all GxP and health-regulated areas, considering data integrity principles

​Country Quality documentation management system:

• Organise a consistent management of Country Quality documents related to GxP and health-regulated activities within the country through an appropriate system
• Provide guidance to country functions that need to develop or update Country Quality documents and related training modules in their respective domains
• Implement a process of screening for released global quality documents and local regulations to capture the requirements that must be transcribed into Country Quality documents
• Ensure required quality documents are in-place, in-use and up-to-date at country level for GxP areas

Country Quality audits and GxP regulatory inspections:

• Provide support to ensure continuous audit and country inspection readiness, in particular through the use of the Inspection Readiness Tools for country organizations
• Manage country regulatory inspections related to GxP processes owned by the CQH and provide support and coordination with other GxP country functions in country regulatory inspections for processes in their respective areas of responsibilities, ensuring contribution of concerned functions at Global level as needed
• Where applicable, and required by local regulation and/or expectations of the local Regulatory Authorities, in conjunction with Regulatory Affairs, support the HA in their GMP inspections of foreign sites. If required, and as agreed at MCCQ level, accompany the HA inspectors on their site visits
• Assure that country inspections of GxP or health-regulated areas are reported by the relevant GxP function in the appropriate company global database
• Define and implement a strategy for local audits based on risk management criteria, of key local GxP and health-regulated subcontractors directly managed by the country. Assure the coordination of the execution of audits managed at country level
• According to local specific needs and regulatory requirements, enroll and complete Sanofi auditor certification program to conduct some local audits
• Evaluate trends in local quality audit findings that may affect the Country Quality system and communicate audit findings require improvement to the appropriate global functions
• Ensure that local critical and major pharmacovigilance or safety related audit findings are managed as per global Sanofi requirements.
• Act as the primary country contact for GxP system quality audits and support Global Quality Audit team in their preparation, conduct and follow-up
• Remain up-to-date on GxP system quality audit reports concerning the country, including any conclusions, decisions made, as well as actions plans.

Training:

• Organise and manage information sharing, training sessions or programs related to processes under the responsibility of the CQH for concerned country associates, according to Sanofi standards and regulatory requirements
• Ensure that there are system, process and procedure in place for the management of GxP &health-regulated trainings across the country by each GxP & health-regulated Function (CQH oversight on trainings owned by GxP & health-regulated Functions)

Country Quality Review:

• Carry-out an annual Country Quality Review and organise the related meeting to present the outcomes to Country Senior Management, as per Sanofi global requirements
• Issue the associated Annual Country Quality Review report and monitor the related Quality Program and Action Plan follow-up

Deviation and Corrective-Preventive Actions (CAPA) management:

• define and implement a process to timely manage deviations and CAPAs related to all GxP and health-regulated activities, including those related to audits and country inspection findings, across the country in a consistent manner, and train concerned associates accordingly

Change Control management:

• set a process to manage proposed changes that may impact GxP or health-regulated process or operations by leading multidisciplinary exchanges, implementing risk assessment and action plans when necessary

Country Quality Performance Indicators (QPI):

• monitor and periodically report country QPIs defined by Global Quality using the appropriate Global Quality computerised system. In addition, define and follow-up on local QPIs, when relevant

Country Quality Agreements:

• ensure that valid and signed quality agreements (with the country as contract giver) are in place with the appropriate Sanofi manufacturing and distribution sites and/or external organizations for all GDP/GMP activities under the responsibility of Quality within the country organization

Other service agreements:

• ensure that quality clauses are in place in service agreements for all subcontractors of GxP and health-regulated activities

Quality oversight of locally managed GxP subcontractors:

• ensure an appropriate quality oversight process of locally managed subcontractors for all GxP and health-regulated activities, either directly (being involved in selection process, qualification and performance of audits) or through coordination with the concerned country functions, as appropriate

Quality risk management:

• Be the focal point in the country for proactive and reactive Quality Risk Management matters
• Ensure that quality risks are properly managed within the country (identification, assessment, control, communication)
• Provide risk management expertise to other country functions as appropriate

Non-product related quality events:

• escalate and manage the events occurring at the country according to defined processes and standards

Administrative records:

• ensure availability of up-to-date administrative records (e.g. CV, job description, training log) for Country Quality associates, as well as updated Country Quality organisational charts - and provide guidance to GxP and health regulated areas be compliant with this requirement

Computerised systems (CS):

• maintain an up-to-date local inventory of GxP CS and GxP spreadsheets and guarantee they are validated by the relevant ITS functions. In addition, assure that non-ITS computerised systems in use within the country for GxP activities are validated by the system owner and in compliance with regulations and standards

Projects:

• lead and coordinate Quality projects. Provide Quality support to new business areas (e.g. acquisitions & divestments) and implementation of digital initiatives, including e-tools.

2. Quality of products

Product complaints

• Oversee managing product complaints received by the country according to Sanofi processes, standards and appropriate tools in force, in connection with the concerned Global Quality functions
• Conduct product complaints trend analysis and signal detection, as appropriate.

Product-related quality events

• Escalate quality events as necessary occurring at the country level according to defined processes and standards and manage subsequent quality and product alerts (as appropriate)
• Lead and coordinate product recalls as per global process
• Provide support to the appropriate functions at country level and according to the defined responsibilities vis à vis Regulatory Authorities (e.g. Qualified Person, Regulatory Affairs to manage notification and communication with Regulatory Authorities for product related quality events)
• Ensure quality oversight on management of product distribution issues including temperature excursion.

Other relevant Quality tasks, where applicable

• Perform local market batch release (batch disposition), vaccines customer certification, ensure quality oversight of distributors (buy and sell products partners), and any other quality activity deemed necessary as per country regulation (e.g. Quality Control analysis, analytical transferences)
• Assure that any local GMP/GDP activities (e.g. manufacturing, repackaging, storage, distribution, testing, etc.) are performed in accordance with applicable GMP and GDP regulations
• Depending on the country organization, manage and make decisions regarding temperature excursion during storage or transport in case of locally managed distribution subcontractor.

Additional Responsibility

• Regional Management of Hong Kong and Taiwan affiliates
• Oversight of Hong Kong GxP Quality matters
• Ensure appropriate processes are in place in Hong Kong regarding product quality and management of operating procedures
• Back up Hong Kong quality head in managing any urgent Quality task while he/she is away from work.
• Regional Quality Audit Responsibilities
• Clinical Study Unit Oversight Responsibilities (GCP)
• Participate Medical Regulatory Pharmacovigilance Quality Council (MRPQ)
• Provide support to Multi-Channel / Innovation Engagement / Computerised System Validation (CSV)
• Full responsibility over new General Medicine, Specialty Care, and Vaccine Quality matters

About You

• University graduate in Life Sciences and Pharmaceutical related Engineering; Pharmacy is preferable
• At least 5 years working experience in multinational pharmaceutical company, preferably in the quality field
• Familiar with Taiwan FDA policies and procedures
• Demonstrate problem solving skills, analytical skills and sense of urgency
• Ability to work in international and transversal teams
• Able to work independently and self-motivated
• Good interpersonal and communications skills
• Positive working attitude with passion
• Good command of oral and written English and Chinese

Why choose us?

• Bring the miracles of science to life alongside a supportive, future-focused team.

• Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.

• Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.

Our Values

Aim Higher: Focus on what matters, set high standards and move with urgency to deliver at speed. Learn from setbacks to achieve tomorrow’s breakthroughs.

Act for Patients: Improving patients’ lives drives everything we do, every day. We aim for simplicity and partner with others to go faster and further for patients. We eliminate barriers to access.

Be Bold: Take thoughtful risks, seize opportunities and think beyond what’s possible to accelerate our science and drive compelling growth.

Lead Together: Build trust and collaborate openly on our shared goals, celebrate collective wins and foster a sense of belonging.