About this role
O bjecti v es of t h e P osi t ion: To lead Nutrition & Health (EN) Quality Management (QM) unit in Asia-Pacific. To ensure Quality Compliance with government regulations. To implement Quality Guidelines. To lead the Non-Conformance process. Driving Quality mindset and act as the primary Quality contact person in the region. Work closely with global & regional teams in QM, Regulatory, Technical Support, Operations, Supply Chain Management, and authorities. Responsibilities : People and Organization Management Lead and collaborate with the Quality team in the countries to ensure clear objectives and targets are in line with Global quality targets Reviewing the country operation data and giving inputs on personnel development and training. Quality Compliance Ensure compliance with FDA FSMA (Food Safety Modernization Act) regulation by coordinating activities with production sites and Business unit Compliance teams (SBU). Work together with country sales, supply chain and country regulatory when applying, interpreting and implementing country regulations, e.g. Food and Drug Administration, Health Science Authorities, Councils, Inspection Services, etc. Conduct and support Quality audits according to internal & external guidelines, and guide external auditors (e.g. from customers or authorities) through an audit, such as FSSC & Fami QS (Food and Feed certification). Ensure compliance with EN Product Steward, e.g. material chemical classification on country level. Provide systems compliance support to company business groups selling products into FDA regulated markets. Ensure regulatory compliance related to computer systems implementation and upgrade project Work together with regional and country supply chain to ensure products are stored and transport at the recommended product storage conditions. Quality Guidelines Responsible for the regional rollout, adaption & implementation of quality guidelines for Food, Feed, Pharma & Aroma in Asia-Pacific. Develop and maintain Quality Agreements and Service Level Agreements (SLA) with BASF sites and 3rd party contract manufacturers, e.g. draft SLA and Quality Agreements with legal (CHQ7), distributors and customers Non-Conformance Management To take on the regional Non-Conformance (NC) key contact role by defining clear accountabilities in handling NCs in the region, engaging in a regional NC community, and conducting joint reviews of NCM performance (cases & response time). To coordinate all EN non-conformances to ensure effective root cause analysis and the implementation of corrective actions to minimize customer impact by the reduction of repetitive complaints. Analyse NC trends and work with business partners (external & internal) to recommend / implement changes to EN business processes where required. To be the regional QM contact person in the crisis process Material Data & Label Management : Take on the role as regional key contact person for SAP material master data and label topics. Quality Community : Actively participate in relevant Food, Feed, Pharma & Aroma trade organizations to keep abreast of industry guidelines and best practices. Support Global EN community for qualification of regional suppliers according to the EN guideline. Create communication matrix among the quality teams in Asia-Pacific. Represent BASF at governmental organizations for the quality part. Ensure timely and accurate completion of customer questionnaires, surveys and other information requests in coordination with global teams. Requirements: Minimum Master’s/Bachelor Degree or PhD in Science, Chemistry or related education. Minimum 10 years with hands-on experience in quality management, strong GMP background, preferable in the food/feed ingredients or pharma industry. Strong knowledge of FDA regulations, QM-systems, standards & processes, good understanding of laboratory operations & methods. Demonstrate cross-functional leadership skills, communication, interpersonal and influence management skills. Ability to multi-task and must be able to organize and direct diverse activities in a changing environment. Establish longer term priorities and contingencies, utilizing strong project management skills to guarantee successful project completion.