Country Quality Manager

Job Title: Country Quality Manager

Location: Mumbai

Our Team:

Our team is an agile and trusted partner Country Quality organization, with skilled workforce, efficient processes, and digital tools for the timely availability of safe products and quality services to patients and customers.

Mission and Purpose:

Manage the implementation and maintenance of the Country Quality system across India, Sri Lanka, Nepal, Bhutan, and Maldives, embarking all concerned country functions (responsible for GxP and health-regulated activities), ensuring that safe, efficient, quality products, information and services are made available to meet patients and customers’ needs

Main responsibilities:

Management of Country Quality System:

·        Define, implement, manage and control a Country Quality system for GxP and health-regulated activities from development to commercialization of all products and related GxP services, in compliance with Sanofi quality documents and standards, as well as applicable local regulatory requirements

·        Enhance Quality culture & promote Quality mind-set into the country governance, working principles and ways of operating

·        Ensure appropriate communication of key messages pertaining to Quality across the country organization, highlighting their possible business impact

·        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

Quality documentation management system:

·        Organize a consistent management of Country Quality documents related to GDP and health regulated activities through an appropriate system

·        A screening process for released global quality documents and local regulations to capture the requirements that must be transcribed into Country Quality documents

·        Provide guidance to country functions including GDP that need to develop or update Country Quality documents and related training modules in their respective domains

Country Quality audits and GxP regulatory country inspections:

·        Provide support to ensure continuous audit and country inspection readiness, in particular through the use of the Inspection Readiness Tools for Country Organization.

·        Support CQH to manage regulatory inspections related to GDP processes

·        Assure that country inspections of GDP or health-regulated areas are reported by the relevant function in the appropriate company global database.

·        Implement a strategy for local audits, based on risk management criteria, of key local GxP and health-regulated subcontractors directly managed by the country. Assure the coordination of the execution of audits managed at country level

·        According to local specific needs and regulatory requirements, enroll and complete the Sanofi auditor certification program to conduct local audits

·        Evaluate trends in local quality audit findings that may affect the Country Quality system and communicate audit findings that require improvement to the appropriate global functions.

·        Ensure that local critical and major pharmacovigilance or safety related audit findings are managed by the relevant function as per global Sanofi requirements

·        Ensure Readiness for GxP system quality audits and support Global Quality Audit teams in their preparation, conduct and follow-up Remain up to date on GxP system quality audit reports concerning the country, including any conclusions, decisions made, as well as actions plans.

Training:

·        Organize and manage information sharing, training sessions or programs related to processes under the responsibility of the CQH for concerned country associates, according to Sanofi standards and regulatory requirements.

·        Ensure that there are system, process and procedure in place for the management of GxP & health-regulated trainings across the country by each GxP & health-regulated Function

Country Quality Review:

·        Support CQH in carrying out an Annual Country Quality Review and to present the outcomes to country Senior Management, as per global Sanofi requirements.

·        Implement the action plan identified for Country quality organization

Deviation and Corrective-Preventive Actions (CAPA) management:

·        Define and implement a process to timely manage deviations and CAPAs related to all GxP including GDP and health-regulated activities, including those related to audits and country inspection findings, across the country in a consistent manner, and train concerned associates accordingly

Change Control management:

·        Set a process to manage proposed changes that may impact GDP or health-regulated process or operations by leading multidisciplinary exchanges, implementing risk assessment and action plans when necessary.

Country Quality Performance Indicators (QPI):

·        Monitor and periodically report country QPIs defined by Global Quality using the appropriate Global Quality computerized system. In addition, define and follow-up on local QPIs, when relevant

Quality Agreements :

·        Ensure that valid and signed quality agreements (with the country as contract giver) are in place with the appropriate distribution sites and/or external organizations for all GDP activities under the responsibility of Quality within the country organization

Quality oversight of locally managed GDP subcontractors:

·        Maintain quality oversight process of locally managed subcontractors for all GDP 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

· Ensuring over labelling controls at approved third party’s facilities in line with Sanofi standards

Quality risk management:

·        Perform proactive and reactive action in Quality Risk Management matters

·        Quality risks are properly managed within the country (identification, assessment, control, communication)

·        Support risk management activity to other country functions as appropriate

·        Non-product related quality events: escalate and manage the events occurring at the country according to defined processes and standards

Computerized systems:

·        Maintain up-to-date local inventory of computerized system at Country quality, for GxP activities in compliance with regulations and standards

Digital Projects:

·        Provide guidance to business in aspects required from quality point of view.

·        Provide inputs as a Permanent member of Digital Governance Committee to provide inputs from Quality requirements

Management of Quality of products:

Product technical complaint:

·        Manage product complaints received from the market according to Sanofi processes, standards and appropriate tools in force, in connection with the concerned Global Quality functions and local regulation

Other Product-related quality events:

·        Escalate product-quality events as necessary occurring at the country level according to defined processes and standards and manage subsequent quality and product alerts (as appropriate).

·        Coordinate product recalls as per global process.

·        Provide support on Quality matters to the appropriate functions at country level and according to the defined responsibilities vis à vis Regulatory Authorities (e.g. Qualified Person, Regulatory Affairs to manage notification and communication with Regulatory Authorities for product related quality events).

Management of Country Batch release

·        Perform local market batch release/ batch disposition in coordination with local health authority as appropriate.

·    Evaluation of the temperature excursions and providing disposition decision based on global sops/Stability studies

About you

Experience: Minimum of 10-12 years of experience in Quality Assurance activities, or any Health regulated, Knowledge & experience in Medical, Clinical or in pharmacovigilance domain, Practical GMP/ GDP experience,Sound knowledge in GxP, local health regulations like, industry guidelines including GCP and other industry standards like Schedule Y-M, OPPI, IFPMA, etc.

• Soft skills:

• Ability to work transversally in a matrix organization & to foster a process simplification approach while meeting compliance requirements, business partnering

• Proper understanding of situations requiring issue resolution & capacity for problem solving

• Easy & quick adaptation to variable situations requiring analysis, evaluation, and constructive thinking, decision making, thoughtful risk taking

• Autonomy with confirmed sense of urgency, priorities & self-control

• Pragmatic, strong common sense, well-organized person willing to drive a compliant

• Performance in a framed environment while facilitating operating paths

• Open-minded & result-oriented team player, customer oriented

• Solid Communication/information skills (towards affiliate Management & Global counterparts)

• Ability to interact efficiently with Competent Authorities/ Inspectorates

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• Technical skills:

• Knowledge of relevant Regulations, Guidelines, both national, regional, and international applicable to affiliate operations, Good Manufacturing Practice (GMP), Good Distribution Practice (GDP) and pharmaceutical legislation,

• Quality Management System & Quality Risk Management

• Deviation & CAPA management

• Auditor qualification

• Education:

   Degree in Pharmaceutical, medical, life science-related field

  Languages: Fluent in English

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