QA Compliance Specialist
Singapour, Singapour Permanent Posté le Aug. 27, 2025Job title: Compliance Specialist
Location: Jurong, Singapore
Hiring Manager: Quality Assurance Manager
About the job:
The compliance specialist is responsible for supporting quality compliance systems within Sanofi Jurong. This role involves ensuring adherence to Good Manufacturing Practices (GMP) and other regulatory requirements through various activities like internal and external audits, complaints and CAPA management, and supporting inspection readiness.
Main Accountabilities:
Inspection Readiness:
- Perform surveillance audits on site to ensure site inspection readiness.
- Coordinate and conduct self-inspections of facilities, operations and procedures to assure conformance with GMPs, and related regulatory requirements. Interface with production, supply chain and external customer to ensure efficient operational processes and timely CAPA closure.
- Supporting site's inspection readiness activities by providing relevant supports during internal audits and regulatory inspections (i.e., FDA and HSA).
- Manage the follow up in the event of audit and inspection findings.
GMP Compliance:
- Ensure compliance to relevant regulatory requirements and other international standards in operations with adherence to GMP through identifying, assessing and escalating potential compliance/quality risks with appropriate mitigation actions taken.
- Coordinates site quality alerts/recalls in timely manner with effective communication.
- Supports investigation and reports on any compliance incidents.
- Tracks status of standard operation procedure (SOP) compliance by performing gap analysis of quality management system through global documents/standards.
- Maintains compliance related documentation by ensuring accuracy and completeness.
Complaint and CAPA Management:
- Manage complaint by ensuring that investigation and corrective/preventive action are performed in promptly manner.
- Supports the implementation and maintenance of complaint management process.
- Assists in the oversight of site complaint handling process by ensuring timely and effective resolution of product complaints.
- Communicates to customers on the status and resolution of the complaints.
- Assisting in investigations into product complaints, including root cause analysis and corrective actions.
- Coordinate site complaint investigations by ensuring thorough root cause analysis and implementing Corrective and Preventive Actions (CAPA).
- Analyses complaint data to identify trends and potential areas for product improvement.
- Manages CAPA to address compliance incidents and preventing recurrence.
Supplier Management:
- Provide quality oversight to suppliers, service provider, contracted manufacturers in areas of supplier and contractor qualification and audit GMP compliance, deviation and change control management, supplier complaints review and approve Quality/Technical Agreement with supplier, contractor and customer
- Involves in supplier audits by ensuring compliance with Sanofi supplier management program.
- Evaluate and qualify new third party (if applicable) based on quality systems, capabilities, performance history and compliance to relevant legal, regulatory requirements.
- Good documentation and record-keeping of third-party quality activities and communications.
- Develop and maintain quality agreements and technical specification with Third Parties outlining quality expectations and responsibilities.
- Identify and mitigated risks associated with third Parties through risk assessments and implementation of corrective actions.
- Establishes an annual audits program of third-party facilities to assess compliance with applicable regulatory requirements (GMP / GDP) and internal documents.
Documentation and Reporting:
- Drafting, reviewing, and updating procedures, as well as generating reports and metrics related to compliance activities.
- Establish and monitor monthly KPI for monitoring and reporting.
Other Responsibilities:
- When required, the incumbent may be responsible for coordinating the timely completion of annual product review and regulatory submissions.
- Supports on the review and approval of deviation/OOS/OOT/ILI investigations Coordinates change control committee by managing topics as a SME for change control system. SAP administrator for SAP-QM module, e.g. inspection plan and CoA.
Work Environment
- This role is based at our Jurong API facility in Tuas (Gul Circle), Singapore, requiring full-time presence on-site.
- The nature of manufacturing operations and the importance of face-to-face collaboration with various stakeholders necessitates working from our facility to ensure optimal team performance and operational excellence.
About you
Experience:
- You hold an engineering/Science Degree or equivalent from recognized institution with 3-5 years of experience in quality compliance within the pharmaceutical industry or equivalent holders with a combination of education and relevant work experience.
- Experience in internal audits, external inspections and supplier management is preferred
- A quick learner with a proactive ‘Can-do’ attitude.
- Adaptable and flexible in managing rapidly changing priorities, with a commitment in supporting site activities with alignment to the manufacturing schedule.
- Discipline and assertiveness in the decision-making and execution of quality related issues.
- Exceptional time management skills with strong attention to detail.
- High adaptability and ability to work independently and write/review reports.
- Strong interpersonal relationships in establishing good partnerships with cross functional teams.
- Good verbal and written communication skills; effective communication and presentation skills and a team player
Toujours Progresser. Découvrir l’Extraordinaire.
Rejoignez Sanofi et entrez dans une nouvelle ère de la science – où votre parcours peut être aussi transformateur que le travail que nous accomplissons. Nous investissons en vous pour que vous alliez plus loin, accélériez votre réflexion et accomplissiez ce qui n’a jamais été fait auparavant. Vous contribuerez à repousser les limites, à bousculer les conventions et à concevoir des solutions plus intelligentes pour les communautés que nous servons. Prêt·e à poursuivre les miracles de la science et à améliorer la vie des gens ? Poursuivons le progrès et découvrons l’extraordinaire – ensemble.
Chez Sanofi, nous croyons dans l’égalité des chances, sans distinction de race, de couleur, d’ascendance, de religion, de sexe, d’origine, d’orientation sexuelle, d’âge, de citoyenneté, d’état civil, de handicap, d’identité de genre ou de tout autre critère protégé par la loi.
Vous n'avez pas encore consulté aucune d'offres d'emploi
Vous n'avez pas encore enregistré d'offres d'emploi.
Évoluez
en tout point.
Repoussez vos limites. Développez votre carrière, votre réseau et apprenez quotidiennement auprès d’experts. Votre nouvelle équipe a besoin de votre énergie et de vos idées pour réaliser des avancées révolutionnaires.
En savoir plus
sur ce site
Un monde de possibilités
-
-
-
Pourquoi Sanofi ?
Accédez aux outils, à la formation et au soutien nécessaires pour atteindre vos objectifs. En réalisant votre plein potentiel, vous nous aiderez à atteindre notre objectif de réduire de moitié le temps entre la découverte et la thérapie.
-
Quand vous évoluez, nous évoluons avec vous
Nous nous engageons à vous soutenir à travers une politique de rémunération complète, soigneusement élaborée pour contribuer à votre bien-être physique, financier, mental et social. Peu importe votre rôle, vous vous épanouirez au sein de nos équipes inclusives.
-
Nos sites
Nous sommes présents dans plus de 60 pays, tous unis pour définir l'avenir de la santé. Votre carrière évoluera aux côtés d'experts et grâce à la technologie au service des plus grandes avancées.
-
Notre culture et nos valeurs
Premiers en pharma avec un comité DE&I, nous valorisons chaque voix. Avec Sanofi, faites entendre la vôtre pour bâtir notre avenir.
-
Construisez une carrière qui a du sens
Exprimez votre passion et impactez des millions de personnes à travers le monde. Vous êtes aux commandes : fixez vos objectifs et nous vous offrirons la formation et le soutien nécessaires pour les atteindre.
-
Lancez votre carrière
Explorez les possibilités : apprentissage, stages, postes pour jeunes diplômés, mobilité internationale. Vous serez accompagné pour avoir un impact significatif.
-
Sanofi Stories
At Sanofi every voice matters. Get to know the talented Sanofians shaping our future and pushing us toward our ambitious goals.
-
-
-
-
Meet Robin, Digital Product Owner, Belgium
Dive into the digital world with Robin Meuris, as he discusses his role as a Digital Product Owner in Belgium.
-
Meet Nils Libert, Associate Scientist in R&D
Meet Nils Libert, an Associate Scientist contributing to groundbreaking research in R&D, Belgium.
-
Meet Stefanie Van Poucke, GMP QA Head
Join Stefanie Van Poucke as she navigates the world of Quality Assurance, leading GMP QA efforts in R&D, Belgium.
-
Meet Ádám Honvéd, Product Owner Process Analytics
Step into the world of analytics with Ádám Honvéd as he shares his journey as a Product Owner for Process Analytics at our Budapest Hub.
-
Meet Azer Hallabi, Project Manager, Global Regulatory Affairs
Discover the dynamic world of regulatory affairs with Azer Hallabi, Project Manager in Global Regulatory Affairs at our Budapest Hub.
-
Meet Orsolya Dina, Receivables & Revenue Team Lead
Follow Orsolya Dina’s inspiring journey as she embraces new opportunities for growth and advancement.
-
Julien Guyomard: From Cars to COVID to Canada
How seizing opportunities built a global career. Julien's career in communications has taken him from the production lines of French car factories to the global stage of the Paris 2024 Olympics and finally to leading communications in Canada.
-
Dachuan Li: From Operating Room to Medical Education
Dachuan Li traded his surgical scrubs for a career bridging science and healthcare as a Medical Science Liaison (MSL) in China.
-
Vincent Dufauret: Embracing the Unexpected - Building a Versatile Career
Currently Global Digital Communication Project Lead, Vincent reflects on his diverse career journey. He shares the insights he wishes he'd understood from the beginning.
-
Carmen's Sanofi Journey: A Son’s Rare Diagnosis, a Renewed Mission
Carmen María Escamilla is Head of Customer Care in Supply Chain, based in Mexico. She discusses how personal experience with her son's rare genetic disorder helped shape her 11-year pharmaceutical career journey and why ensuring medicine availability has become her mission.
-
Balancing Career and Family: How Sanofi's Employee-First Culture Creates Opportunity in China
Lewis Lai, Direct to Patient (DTP) & Dual channel Pharmacy (DCP) Channel Manager based in Hangzhou, China, shares how Sanofi's supportive workplace policies and culture have enabled him to thrive professionally while embracing fatherhood.
-
One Sanofi Career, Many Chapters: Bold Moves and Saying ‘Yes’ Drives Growth
Istanbul-based Şayan Tomris Örs, currently Polio, Pertussis, and Hib (PPH) Head of Eurasia for Vaccines at Sanofi, discusses her journey from chemical engineering graduate to marking leader to head up a franchise.
-
Sustainability at the Heart: How Sanofi's Transformation is Building a Purpose-Driven Culture
Serena Ceccarelli reveals how Sanofi's integrated approach to sustainability is transforming the pharmaceutical giant while creating lasting social value through ambitious environmental targets and expanded healthcare access.
-
Finding Purpose at Sanofi: A Finance Professional's Path to Making a D
Hungarian Senior Financial Analyst Zoltán Borbás shares how the Budapest Hub offers a springboard for career growth while working for a company with real-world impact.
-
Team Science: Building Breakthroughs Across Borders and Disciplines
Frankfurt-based Dr. Nadine Biesemann, Distinguished Scientist and Section Head for Immunology Research at Sanofi, reflects on how collaborative approaches and diverse perspectives accelerate medical innovation.
-
Lab Bench to Global Strategy: How Scientific Passion Led to Immunology Leadership
Aayam Lamichhane, Head of Strategy and Operations for Sanofi's Global Immunology Franchise, shares how his childhood fascination with science, a commitment to serving patients, and a drive to create meaningful change in the world led to a remarkable career journey across continents.
-
-
-
-
Meet Matthew Odogwu, Associate Brand Manager Flu & Travel, UK & Ireland
Matthew is one of Sanofi’s Emerging Talent Graduate Scheme participants. Through hands-on rotations across different business units, he’s developed a diverse skill set – from tender management to marketing – while gaining real ownership and accountability.
-
Meet Douglas Penson, Sustainability Apprentice, UK & Ireland
Douglas is a Corporate Responsibility and Sustainability Apprentice with a passion for the environment. Through his apprenticeship at Sanofi, Douglas is gaining valuable knowledge and contributing to meaningful, purpose-driven work.
-
-
How Motherhood Accelerated My Career at Sanofi
Bangkok-based Wipada Kitiratanatrakarn, Brand Lead for Polio, Pertussis, and Hib Vaccines across Southeast Asia and India at Sanofi, reveals how becoming a mother transformed her approach to leadership and opened doors she never thought possible.
-
Finding The Role I Was Meant For
Le Thanh Man, Customer Engagement Manager for Sanofi Vaccines in Vietnam, reveals how early rejection became the catalyst for a decade of intentional growth, and how Sanofi's career development resources helped him build the career he'd always envisioned.
-
Making an Impact Beyond the Office
From disaster relief in California to mentoring young scientists and joining the global stage at the Paris Olympics, each experience can deepen your sense of purpose – and help your career take root and thrive.
-
Ignite Your Potential: Lana
Lana is motivated to solve rare diagnosis puzzles for millions of patients – all by seeing the bigger picture through their eyes.
-
Ignite Your Potential: Denise
Denise explains how Glauber, her beach tennis coach, gives her the confidence to always push for better.
-
Ignite Your Potential: Eldar
Eldar’s dad taught him to always persevere and push for better outcomes – even when the odds are stacked against you.
-
Ignite Your Potential: Paul
Watch Paul discuss how his partner’s uncle inspired him to never settle and always put patients at the center of what we do.
-
Ignite Your Potential: Sam
Sam’s mom pushed her to be a better listener and always put patients at the center of what we do.
-
Ignite Your Potential: Cordula
Cordula’s manager, Paul, always had faith in her. That’s what helped her to believe in herself. Now she’s helping her colleagues transform medicine.
-
-
What makes Sanofi unique?
Sanofi is more than a global biopharmaceutical company, we are a place where purpose, people, and innovation come together.
Rejoignez notre communauté
de talents
Que pourrions-nous accomplir ensemble ? Chaque Sanofien travaille sur des projets qui ont un véritable impact sur la vie des gens.
Inscrivez-vous dès aujourd'hui et découvrez nos dernières opportunités dès qu'elles seront disponibles.