Asia Quality Director
Support Novacyl Asian sites for quality, compliance and projects in collaboration with the global quality products and project manager.
This post is based in Wuxi (China) because the center of gravity is located in China.
However, this implies many trips to China, Thailand, Asia in general and France in the context of reporting with headquarters and relations with customers, service providers, key suppliers and authorities and internally with the Corporate quality team, business, industrial, supply chain, finance & HR.
Ensure a shared presence between the sites (Routinely and for inspections). Around 30% in Thailand, 60% in China and 10% in France in a normal situation.
Mission 1: Ensure compliance of operations at site level for Novacyl Asian sites Bangpoo (Thailand), Wuxi and Puyuan (China).
– Ensure that the site quality managers are trained to and follow the corporate standards and requirements
– Is involved in important site quality decisions & in the management of all critical/major site quality issues
– Ensures that at site level the systems for managing: complaints, deviations, validations, training, calibration, release and rejections of raw materials, intermediates, APIs and finished products, document system including procedures, specifications, master batch records, product return, PQR, internal audits, change control, testing, stability, approval of contractors are well understood and applied
– Ensure that the PQR are correctly performed and that there is a CAPA system in place to follow-up of actions identified
– Support the sites for the preparation, response and follow-up of inspections. Participate to regulatory inspections on the sites, Authoring corporate documents (SOP, guidelines, standard…) which can support the site compliance
– Gathering KPIs from the sites, present and analyzing them to propose improvement measures, Escalating any critical situation.
Mission 2: Ensure compliance of projects
– Plays an active role in the definition of the necessary steps to ensure the compliance of new products and projects for Novacyl’s sites
– Makes sure that such steps involving the quality departments are adequately performed, Ensure that the site quality managers follow the corporate standards and requirement
– Takes active part in the selection of new products or new peo (CMO) in good compliance with NOVACYL Policies and regulatory requirements.
Mission 3: HR development, organization efficiency
– Coach, train, supervise the Asian Site Quality Managers and define their yearly objectives
– Organize and lead regular one to one and joint meetings with the Asian Site Quality Managers and ensure minutes are in place
– Propose and implement an enhanced organization with appropriate back-ups, Promote Quality and develop Quality culture across the sites.
Mission 4: Punctual support on other Novacap GMP activities, like Yangzi or Novabay when necessary
– Education : B.Sc. In Pharmacy or equivalent
– At least 10 years working experiences in QA/QC functions, cGMP
– Working experiences in pharmaceutical and/or chemical industries (API), International exposure
– Strong ability to deal with Pharma, cosmetic markets regulation. Good knowledge of US and European legislations.
– People management, Team player, Understanding of Asian and American cultures
– Language : English in day-to-day management and interfacing
– Technical : good knowledge of GMP, knowledge of tools, concepts and methodologies of QA (such as Risk Management for example), knowledge of relevant quality requirements (ICH, Eudralex and CFR guidelines for example)