Quality Assurance & Control (Science & Technology)
Full time
About the job Do you have Development or Quality experience within Complementary Medicine or OTC industry and looking for long-term growth with a global leader?
The Development Quality Manager is part of the Global Quality and Sciences team and responsible for leading and managing the implementation of the Sanofi and OPELLA global Quality standards to create a state-of-the-art approach across the business.
Ensuring our OTC, Complimentary medicines, and Food Supplements products are of the best standard for our consumers, you are also responsible for championing a Quality culture across the Development Center and cross-functionally, educating, and leading all Quality activities and continuous improvement initiatives.
Main responsibilities: Accountable for the implementation, management and improvement of the Quality activities in the Development Center for regulated development activities across the organisation by:Implement and manage quality systems in compliance with company standards and processes, in accordance to DC specificities- including ownership of setting the yearly local Development Quality RoadmapBe a trusted and transformational business partner to all the Leader Team in Virginia DC and with other local and global stakeholdersDevelop quality culture locally and lead quality culture events (incl promotion & visibility)Support the team navigate quality in a context of project pressure and build the rationale from the rules to educate and convince teamsProvide reports of Development Quality highlights to global team and report relevant information to prevent or revert quality crisisManage Quality Documents (QD), Ensure an efficient QD system is in place in the Development Center by securing process and QD compliance to the company standardsBe the final reviewer and final approver for procedures, documents, protocol, and reports in terms of quality (logbooks, calibration, maintenance, qualification, temperature & humidity, stability….
)Oversee Training management by: Manage training curriculum, assign training as required and follow-up / deliver GMP training programLead Audit & inspections (readiness, conduct and follow up) and manage self inspectionOrganize the preparation for quality audits and inspections at DC; welcome auditors/ inspectors, act as the interlocutor for DC, follow-up on audit and inspection & manage self-inspectionOversee Development suppliers and third-party quality management, Review qualification status and Check related Quality documentsCollaborate with the Head of Formulation and the Head of Analytical as the Quality expert to ensure high quality of productsManage related quality activities: events & CAPA, analytical validation, QRM, suppliers/third parties ..Review and approve related documents: specification development report, specification, formula checking with restricted ingredient list…Lead quality continuous improvement and proactively grow quality in DCProactively and promptly deploy and apply in DC new, advanced and modern quality applications following the trend of digitalizationAbout youExperience: Experience in R&D Quality Management and/or Development (ideally 3 years), and Quality systems, in Complementary Medicines preferred.
OTC or Food supplements also consideredProven ability to effectively communicate and present to senior stakeholders, and collaborate with global teamsTechnical & Soft skills: Ability to be the go-to Quality expert and Business Partner to the Development CenterActive listener and Influencing skills are criticalStrategic thinking, ability to step back and explain basic steps in a constructive mannerAutonomous and flexible in your working hours to work with a highly global teamHigh level of assertiveness and networking/collaboration capabilityBring level of enthusiasm to create, reflect and educate a Quality cultureLanguages: English is compulsory (working language) - other languages welcomed #J-18808-Ljbffr