Job title:Head- Quality Assurance

• Location - Mumbai

• 40% Remote working and 20 % of travel expected

• Job type: Permanent

Our Team:

External manufacturing India is managing Sanofi products manufactured at CMO’s (Contract Manufacturing Organizations) located in India and other Asia pacific region. EM India is managing various types of formulations including solid orals, semi-solid, liquids and parentals. Our team is managing activities related to manufacturing, Quality, Regulatory and supplies of products manufacturing at CMO’s.

Purpose:

Ensuring implementation and monitoring of the Quality systems at Sanofi’s External manufacturing sites as per cGMP and Sanofi Global quality document requirements in order to ensure the quality of products delivered to market. 

Our Mission:

We Lead and manage the Quality strategy within the External Manufacturing site’s network to ensure that drug products manufacturing and distribution activities are in compliance with the Global Quality standards and applicable regulatory requirements.

Main responsibilities:

Operational Management of CMOs:

• Lead and manage the Quality operations team, ensures the cGMP and Quality Management Compliance at CMOs.
• Management and ensuring Operational activities of pharmaceutical products at identified CMOs comply with the requirements of the Sanofi Quality directives and meet all relevant cGMP & regulatory requirements.
• Monitor and ensuring that all the drug products are timely released in accordance with the registered specifications and in accordance with local regulations.
• To ensure validations, qualifications at CMO site.
• Ensuring the compliance of the product through testing as per specification, change management, stability studies, deviation and investigation, OOS and market complaint systems.
• Participate and guide QA managers team for appropriate evaluation and implementations of Quality compliance at CMO’s.
• Ensuring the CMO compliance as per the respective Quality Agreements.

Quality Management System:

• Ensuring the QMS systems compliance as per the Sanofi Global procedures.
• Participates in evaluation and defining CAPA / action plan / Investigations, alignment and implementation at CMO sites.
• Responsible for assessing and approval of Quality trends through APQR’s and driving Continuous improvement for processes and product quality performance.
• Investigations of Product technical complaints for products manufactured at external manufacturing sites.
• Management of quality Escalation of events, initiated from any of the quality system.
• Identify, control and escalation of proactive risk at CMOs.
• Regular oversite the hub activities to ensure the compliance and adherence to the KPIs.

• CMO Quality reviews:

• Responsible for executing and ensuring the site quality reviews as per the SQR calendar and highlighting the potential observations & actions plan to the management. Ensure implementation of action plan in timely manner.
• Define and ensuring the implementation of Quality improvement plan for CMO’s.

• Quality Agreements:

• Responsible for ensuring and maintaining valid Quality agreement with CMO’s/ suppliers, defining cGMP roles and responsibilities between Sanofi and the CMO’s. Perform the required periodic review and negotiation with CMO and make recommendations for amendments to the agreement based on identified needs.

• Ensuring Quality & Regulatory compliance and Inspection at CMO’s:

• Ensuring Quality and regulatory compliance at CMO’s, by On-Site Quality review as per planner and ensuring implementation of registered Dossier at site.
• Ensure audit readiness at CMO for regulatory audits at CMO’s.
• Ensuring timely completion of the compliance to the local and export regulatory audits of the contract manufacturing sites.

• Perform Quality Risk assessment:

• Responsible for identifying the Risk and investigating for identifying potential quality risk and assigning appropriate CAPA for risk raised/identified for CMO’s.
• Conduct the CMO risk ranking as per the frequency for the assigned CMO’s. Timely discuss and align the Action plan for the improvement of CMO risk ranking with EM India management. 

• Other Key Quality Responsibilities:

• Implementation of Global procedures through impact assessment.
• Monitoring of Quality KPIs and identify to take action (if any required)
• Evaluate the new drug product sites, ensuring Due Diligence for new product evaluation and follow up on compliance to ensure the timelines of product launches from CMO.
• To lead, participate, support the projects of technology transfer/Continuous Improvement projects for new products or existing products identified and allocated as per project Management.
• Ensure smooth analytical and manufacturing transfer through close working with transferring site and receiving site.
• Post audit assessment of CMO and supplier as a requesting site.
• Ensuring product artworks review and compliance of current artworks at CMO.
• Ensure a cross-functional alignment within Sanofi, and with the assigned CMOs to control all processes required for receiving products from CMOs in terms of quality, compliance, time, volumes, and costs during the overall contract life cycle.

About you:

• Experience: (>12 years of experience in Quality Assurance, 2-4 years team handling)
• Soft skills: Team handling, Stakeholders management, Effective communication with external partners -CMO's, and ability to work independently.

• Technical skills: Quality Assurance, Quality Control, Effective Analyzing skills, Strong cross-functional collaboration, teamwork, and stakeholder management. Handling of different pharmaceutical dosage forms
• Managerial courage – ability to make difficult decision and implement successfully

• Education: (B.Pharm/ M.Pharm/ MSc/PhD in lifesciences)
• Languages: English, Hindi

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