Country Quality Manager
Genzyme
Taipei
20小时前

JOB PURPOSE :

  • Lead and manage the implementation and maintenance of the Country Quality system across the country organisations, embarking all concerned country functions (responsible for GxP and health-regulated activities), ensuring safe, efficient, quality products, information and services are made available to meet patients and customers’ needs.
  • KEY ACCOUNTABILITIES :

    Management of the Country Quality system

  • Define, implement and maintain a Country Quality system applying to GxP and health-regulated activities related to the development, manufacturing, distribution and commercialisation of all products under development or marketed by Sanofi Global Business Units or through partnership agreements, in compliance with Sanofi Quality reference standards
  • Enhance Quality culture & promote Quality mindset into the country governance, working principles and ways of operating
  • Ensure appropriate communication of key messages pertaining to quality across the country organisation, highlighting their possible business impact
  • Lead and coordinate a network of professionals designated in each country function involved in GxP and health-regulated activities and embark them to address all matters related to quality
  • Assure that a process for management of GxP documents and records is in place in all GxP and health-regulated areas, considering data integrity principles
  • Organise a consistent management of Country Quality documents related to GxP and health regulated activities within the country through an appropriate system
  • Ensure required quality documents are in-place, in-use and up-to-date at country level for GxP areas
  • Provide support to ensure continuous audit and inspection readiness, in particular through the use of the Inspection Readiness Tools for Affiliates
  • Manage country regulatory inspections related to GxP processes owned by the CQH and provide support to and coordination with other GxP country functions in country regulatory inspections for processes in their respective areas of responsibilities, ensuring contribution of concerned functions at Global level (as needed)
  • According to local specific needs and regulatory requirements, enrol in and complete Sanofi auditor certification program to conduct himself some local audits
  • Act as the primary country contact for GxP system quality audits and support Global Quality Audit team in their preparation, conduct and follow-up
  • Organise and manage information sharing, training sessions or programs related to processes owned by the CQH for concerned country associates, according to Sanofi standards and regulatory requirements
  • Carry-out an annual Country Quality Review and organise the related meeting to present the outcomes to Country Senior Management Board
  • Issue the associated Annual Country Quality Review report and monitor the related Quality Program and Action Plan follow-up
  • Define and implement a process to manage deviations and CAPAs related to all GxP and health-regulated activities including those related to audits and inspection findings, across the country in a consistent manner, and train concerned associates accordingly
  • Set a process to manage the changes that may impact GxP or healthregulated process or operations by leading multidisciplinary exchanges and action plans when necessary
  • Monitor and periodically report country QPIs defined by Global Quality (in addition to any other locally defined quality indicators) using the appropriate Global Quality computerised system
  • Ensure that valid and signed quality agreements (with the country as contract giver) are in place (with Sanofi manufacturing sites, distribution centres as well as with any third party sites) for all GDP / GMP activities under the responsibility of Quality within the country organization
  • Ensure that valid and signed service agreements containing quality dispositions and other mandatory quality related clauses are in place for all subcontractors of GxP and health-regulated activities
  • Ensure an appropriate quality oversight process of locally managed subcontractors for all GxP and health-regulated activities, either directly (being involved in selection process, qualification and performance of audits) or through coordination with the concerned country functions (as appropriate).
  • Quality risk management : Be the focal point in the country for proactive and reactive Quality Risk Management mattersEnsure that quality risks are properly managed within the country (identification, assessment, control, communication)Provide risk management expertise to other country functions as appropriate
  • Escalate and manage the events occurring at the country according to defined processes and standards
  • Ensure the maintenance of a up-to-date local inventory, together with relevant IS functions, and that local computerised systems in use within the country for GxP activities are in compliance with regulations and standards.
  • Quality of products

  • Product complaints : Manage product complaints received by the country according to Sanofi processes, standards and appropriate tools in force, in connection with the concerned Global Quality functionsConduct product complaints trend analysis and signal detection, as appropriate.
  • Product-related quality events : Escalate quality events as necessary occurring at the country level according to defined processes and standards and manage subsequent quality and product alerts (as appropriate)Lead and coordinate product recalls as per global processProvide support to the appropriate functions at country level and according to the defined responsibilities vis a vis Regulatory Authorities (e.
  • g. Qualified Person, Regulatory Affairs to manage notification and communication with Regulatory Authorities for product related quality events)Ensure quality oversight on management of product distribution issues including temperature excursion.

  • Batch Release of Product : Full responsibility over all batch release activities.Prepare the batch release dossier and submit to TFDA for approval.
  • Check the temperature during shipping and the artwork product if they are registered.

  • Additional Responsibilities : Regional Quality Audit Responsibilities (ASIA)Clinical Study Unit Oversight responsibilities (GCP)Participate Medical Regulatory Pharmacovigilance Quality Council (MRPQ)Provide support to Multi-Channel / Innovation Engagement / Computerised System Validation (CSV)Full responsibility over new Primary Care, China & Emerging Markets, Genzyme, Pasteur and CHC Quality matters.
  • JOB-HOLDER REQUIREMENTS :

    Education :

  • University degree in one of the following field of science : Pharmacy, Chemistry, Microbiology / Biology, Industrial Pharmacy
  • Experience & knowledge :

  • The position requires at least 5 8 years’ experience in the pharmaceutical industry, preferably in the following fields (combination of) : Quality Assurance, Quality Control, Manufacturing, Drug Regulatory Affairs, Medical Affairs
  • Familiar with local regulations and Taiwan FDA policies
  • Knowledge and experience in regulatory requirements and international standards : PIC / S GMP, ICH, ISO, and / or GDP experience is preferable
  • Core competencies / skills :

  • Able to communicate within the company and externally in an effective and authoritative manner, both in writing and verbally
  • Strong interpersonal and social skills to represent the Company and able to communicate at all levels both internally and externally.
  • A demonstrated ability to influence key stakeholders and develop internal business partnerships with international and transversal teams

  • Demonstrates capacity to understand key quality issues which impact on the commercial operations
  • Demonstrates problem solving skills, sense of urgency, especially with respect to enforcing safety rules and global procedures
  • Shows integrity, tenacity, resilience and adaptability in complex situations and often changing environment; able to handle pressure and respect deadlines
  • Positive attitude and be proactive and pragmatic
  • Good industry contacts and leadership
  • Good command of oral and written English and Chinese
  • Good presentation skill; spoken communication must be clear and confident; and must show evidence of good listening skills
  • At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers.

    We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.

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