Description This position needs to ensure Galderma products meet the Company quality standards and comply with the relevant government regulations according to the product applicable classification: cGMP, GDP, ISO, ICH, or any relevant regulations and guidance.
As ESO Quality Specialist, this person will rely on regulatory, industry, and technical expertise to select, monitor, guide, and promote Quality at CMOs / CDMOs and support Galderma Markets / distributors on products provided by CMOs. This person will also have an important role with API suppliers.
Key Responsibilities: Promote improvement programs and alignments in all related CMO / CDMO.Be actively involved in the resolution of critical / major quality issues (leading to supply issues) and to discrepancies found through audits, inspections, or complaints and their related investigations.Accompany CMO / CDMO to favor continuous improvement programs and preventive actions over corrective actions.Provide expert interpretation and application of regulatory guidelines to ensure that CMO / CDMO / API Suppliers adhere to regulatory requirements and are consistent with industry standards.Notify management of significant quality or regulatory issues that may impact product quality or regulatory compliance.Skills & Qualifications: Solid experience in Quality Assurance role.Strong knowledge of the applicable regulations for drugs, cosmetics, medical devices, or a similar industry.Capacity to negotiate and manage external partners.Possess the ability to work in a matrix organization (affiliates, global, CMO / CDMO).Communicate clearly and professionally in both writing and verbally in English and French.Flexibility and agility in problem-solving, providing direction to meet business objectives are expected.What we offer in return: You will be working for an organization that embraces diversity & inclusion and believes we will deliver better outcomes by reflecting the perspectives of our diverse customer base.You will receive a competitive compensation package with a bonus structure and an extended benefit package.You will be able to work in a hybrid work culture.You will participate in feedback loops, during which a personalized career path will be established.You will be joining a growing company that believes in ownership from day one where everyone is empowered to grow and to take on accountability.
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