Job Title: Global Product Development Quality Specialist Location: Shanghai, China
Job Description The Product Development Quality Specialist – Consumer Products Role is part of the Product Development Quality team. As the Global Product Development Quality Specialist, you will ensure that Galderma products meet the company quality standards and comply with the relevant government regulations according to the product applicable classification: cGMP, GDP, ISO, ICH, CSAR or any relevant regulations and guidance with a strong focus on Consumer Business. The development of new consumer products (Cosmetic and OTC) require your proactive leadership in the interdisciplinary projects teams.
Key Responsibilities 1.Lead the product innovation projects with focus on China and JPAC Consumer product (Cx) launches in Quality. 2.Actively participate and represent Quality in the appropriate product development team meetings. 3.Enhance the knowledge of the team in JPAC and China Regulatory and Quality legislations in Cx R&D projects. Create / revise development procedures accordingly. 4.Review and approve product / packaging component specifications in close collaboration with R&D and MS&T teams. 5.Apply STSC testing requirements in cosmetic product development for China market. 6.Responsible to work with R&D, MS&T and Operations teams to ensure design and development of products contribute to improving processes and achieving target launch Quality goals. 7.Responsible for ensuring adherence to the relevant applicable regulatory GMP requirements as well as Galderma’s internal requirements throughout all the processes in product development projects. 8.Lead the Quality Risk Management for his/her projects and use the Lean and Lean Six Sigma methods to minimize Compliance and Supply Chain Risks. 9.Lead the resolution of quality issues identified in projects. 10.Responsible to initiate, perform and document quality investigations, deviations and CAPA’s related to product development in Galderma QMS. 11.Initiate, assess, and handle Change Controls in Galderma QMS and work with all stakeholders for timely implementation of the changes. 12.Responsible for stability studies of products during development projects. 13.Support vendor qualification program in JPAC. 14.Promote improvement programs and alignments for C(D)MO(s) involved in the projects. 15.Share knowledge and train colleagues on relevant regulations. 16.Ensure customers' satisfaction as well as regulatory compliance in all markets. 17.Manage and/or support all quality aspects for products through its entire lifecycle, from development to commercialization. 18.Support transition of product development deliverables to the relevant stakeholders within Operations & Commercial Quality and provide support on quality issue(s) linked to product development arising post-transition. 19.Design and coordinate the implementation of the company Quality Management System and promoting its continuous improvement with strong focus on enhancing the QMS according to applicable JPAC and China Quality legislations for cosmetic and OTC products. 20.Evaluate the robustness of the QMS and weigh in on quality risks. 21.Ensure all documentation related to product development are done properly according to GDP’s and maintained in Galderma Document Management System. 22.Participate in creation and revision of Galderma procedures and work instructions related to product development incorporating JPAC and China CSAR requirements. 23.Actively support as the main Quality person in continuous improvement projects related to the company QMS and Document Management System. 24.Work with all stakeholders and promote GMP and the GMP compliant way of working, including support the implementation of evolving regulatory requirements during product development phase and/or post-transition. 25.Perform training on GMPs and GDPs as needed.
Skills & Qualifications 1.A bachelor’s degree in science (Chemistry, Biology, Pharmacy) or in a relevant subject 2.Minimum 8 years of experience in a Quality role in pharmaceutical / cosmetic industry. 3.Experience with global Cosmetics/OTC GMPs with focus on JPAC and China CSAR regulations is a must. 4.Strong knowledge of STSC testing requirements according to China Regulations for cosmetic products. 5.Experience in Cosmetic/OTC production and process improvements are strong assets. 6.Medical device GMP experience and knowledge is a strong asset. 7.Quality auditor certification is a strong asset. 8.Knowledge of Project Management, Lean and Lean Six Sigma, and Quality Risk Management are strong assets. 9.A demonstrated knowledge and execution in Quality Management System (QMS) 10.Ability to manage external partners. 11.Possess ability to work in matrix organization (affiliates, global, vendors and partners). 12.Communicate clearly and professionally both in writing and verbally. 13.Ability to interpret and relate quality standards for implementation. 14.Flexibility and agility in problem solving, providing direction to meet business objectives as expected. 15.Fluent in English (written & spoken)