Quality Manager (m/f)

Description

• Manage portfolio of projects, support a discipline and/or provide a service (if applicable, you may provide functional expertise in area of responsibility)
• Review and recommend disposition of deliverables (e.g. procedures, records, third party work, contractors, clinical trial material, components) and related tools (e.g. IT, document systems, training tools, facility validation) to ensure GMP compliance
• Support project related activities (e.g. interpret results, evaluate data, draw relevant conclusions)
• Perform inspections and audits as required
• Contribute to the evaluation of new QA tools
• Write GMP relevant documents in own area of responsibility (e.g. SOPs with global applicability).
• Provide support to TRD line functions in GMP compliance related issues (e.g. training, document management)
• Meet internal and external guidelines regarding quality and safety (quality manuals, regulatory cGMP guidelines, health authority guidance, SOPs, HSE etc). Promote and enforce compliance to guidelines (if you are managing associates, ensure same for them)
• Lead and support direct reports in line with company values and behaviour, including objectives setting, performance evaluations, development planning and participate in recruiting process

• Basic degree in scientific or relevant discipline (BS or equivalent)
• Profound relevant experience
• Sound scientific, technical and regulatory knowledge in a specific area
• Very good knowledge of cGMPs
• Ability to analyze and evaluate GMP compliance
• Good knowledge in English (oral and written) required