Development Quality Manager Location: Virginia, Brisbane
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 is 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.
At Opella, the Consumer Healthcare business unit of Sanofi, is the purest and third-largest player globally in the Over-The-Counter (OTC) & Vitamins, Minerals & Supplements (VMS) market.
Join us on our mission. Health. In your hands.
Main responsibilities: Accountable for the implementation, management, and improvement of the Quality activities in the Development Center for regulated development activities across the organization 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 Roadmap. Be a trusted and transformational business partner to all the Leader Team in Virginia DC and with other local and global stakeholders. Develop 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 teams. Provide reports of Development Quality highlights to global team and report relevant information to prevent or revert quality crisis. Manage Quality Documents (QD), ensuring an efficient QD system is in place in the Development Center by securing process and QD compliance to the company standards. Be 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 managing training curriculum, assigning training as required and following up / delivering GMP training program. Lead Audit & inspections (readiness, conduct and follow up) and manage self-inspection. Organize 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-inspection. Oversee Development suppliers and third-party quality management, review qualification status and check related Quality documents. Collaborate with the Head of Formulation and the Head of Analytical as the Quality expert to ensure high quality of products. Manage 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 DC. Proactively and promptly deploy and apply in DC new, advanced and modern quality applications following the trend of digitalization. About you Experience: Experience in R&D Quality Management and/or Development (ideally 3 years), and Quality systems, in Complementary Medicines preferred. OTC or Food supplements also considered. Proven ability to effectively communicate and present to senior stakeholders, and collaborate with global teams. Technical & Soft skills: Ability to be the go-to Quality expert and Business Partner to the Development Center. Active listener and influencing skills are critical. Strategic thinking, ability to step back and explain basic steps in a constructive manner. Autonomous and flexible in your working hours to work with a highly global team. High level of assertiveness and networking/collaboration capability. Bring level of enthusiasm to create, reflect and educate a Quality culture. Languages: English is compulsory (working language) - other languages welcomed. Why Choose us? 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. Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks' gender-neutral parental leave for permanent employees. Endless development opportunities and career trajectory, highly supportive team environment. Join a global leading Healthcare organization with consumer loved products and our very own home-grown Australian brands! State of the art facilities in beautiful Brisbane. High performing and supportive team environment, where we encourage you to have work-life balance. Pursue progress, discover extraordinary Better is out there. Better medications, better outcomes, better science. But progress doesn't happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let's be those people.
At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.
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