Head Quality Assurance

Job title:Head QA- Digital & Projects

• 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:

Digital Transformation:

- Implementing the process and tool at local level in line with the standardized and harmonized approach, including communication, change management, etc. as appropriate.

- Providing feedback on the roadblocks and difficulties met related to CoP area supported.

- Providing return on experience on inspection assessing the CoP area supported.

- Proposing evolution for simplification and harmonization of the process and tool.

- Sharing successes and best practices with other sites.

- Contributing to the objectives set via the CoP roadmap.

- Cascade all relevant information to all impacted stakeholders and ensure that the application of the process is well deployed and implemented at entity level when needed to ensure adherence to the standardized approach defined during the CoP

-Act as primary focal point for digital initiatives coming from global

-Promote a performance & data driven mindset, leveraging the power of digital tools

-Ensure the effective use of Digital to transform Quality & Regulatory department operations according to the EM&S digital roadmap to deliver impact.

-Use of digital tool One Quad for Quality KPI reporting.

-Act as SME for Global Digital Transformation

Project Management:

• Collaborate  with the team of projects managers in charge of activities related to technology transfers, new product launches, new API source qualification and validation activities (process, analytical) requiring transversal coordination
• Ensure efficient partnership with other functions involved in project management, especially Technical Operations and operational support functions
• Ensure projects are delivered on time, at expected cost and right quality level
• Ensure that changes during projects are evaluated and their impact on planning, costs
• Ensure that risks identified during project are escalated according to procedure in force

Process Enhancement:

• Lead and coordinate deployment of SMS tools within Quality & Regulatory Department: SMS training, VSM/VSD, DGBI, +QDCI, GPS3
• Deploy and maintain global quality programs (e.g. Quality Maturity Index, Data integrity)
• Collect, report and analyse KPIs of Quality & Regulatory department (e.g. +QDCI, Global Quality KPIs) and propose improvements.

CMO Performance Monitoring:

• Ensure quality contracts are in place and updated with CMOs, suppliers, third parties and internal stakeholders
• Track and report quality performance of all CMOs & Suppliers within its perimeter.
• Oversight the performance of the Complaints, audit PQR and SQR Planner Execution on time.
• Coordinate the preparation of Business Review meetings with CMOs for all that is related to Quality & Compliance aspects
• Ensure system is in place to monitor and maintain CMO, suppliers and third parties qualification
• Ensure and Coordinate audits planning and execution (CMO, suppliers, Third parties, self-inspections)

Quality System Management:

• Ensure and escalate the adverse trending to Operational team on regular basis for meeting the Quality KPI targets.
• Conduct regular training on Digital tools and workflows.
• Ensure the right QMS workflows are followed as per global procedures.
• Supervise and coordinate GMP training programs for EM&S GenMed APAC Hub
• Maintain EM&S GenMed APAC quality documentation using Sanofi CMS tool, ensuring implementation of Global Sanofi documentation
• Ensure implementation of global Quality Management System tools (change control, Third party qualification, Events and CAPA, etc.

Audits & Risk Management:

• Act as primary focal point for, HA Audits and internal audits (Self Inspection)
• Coordinate Risk reviews and annual Quality Review for the EM&S GenMed India
• Ensure and Perform the Access review of all Digital tools for Users in entity.

Computerized System:

• Maintain the inventory of Computerized system as per global procedures.
• Ensure and execute the qualification of Local Computerized system.
• Coordinate with global for qualification records for Global computerized system.
• Act as tester in local/global computerized system as and when required.

About you:

• Experience: (>12 years of experience in Quality Assurance)
• 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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