Site Quality management L3-2

Job title:Head Site Quality

• Location Verna Goa

About the job

Main responsibilities:

Key Focus Areas:

• Leadership & Strategy: Responsible for implementing Sanofi's Quality Policy, ensuring regulatory compliance and driving quality performance across all site operations while serving as the primary quality representative to Health Authorities. The role encompasses strategic quality leadership including batch release decisions, inspection readiness, manufacturing license maintenance and developing a high-performing quality team to ensure products are delivered with the right quality, on time and in full regulatory compliance.

• Operations Management: Responsible for site Quality management organization including Quality Control, Quality Assurance, Quality system and Compliance as well as Regulatory department. Drive site quality performance and ensure business continuity.

• Quality Management System: Ensure implementation of QMS at the site in adherence to the Site SOPs and Sanofi Global Standard requirements. Plan and provide adequate resources to execute the Quality Operations. Approval of Site Master File (SMF). Approval of contract testing / manufacturing third parties and Approval of Technical Agreements and Quality Agreements. Approval of Validation Master Plan, Qualification / Validation protocols and reports. Participate in various forums at the site/ cluster and contribute towards system implementation of various activities at the site. Implement robust quality systems and continuous improvement practices. Ensure timely implementation of CAPA and closure of all critical, major and minor deviations. Support direct handling and resolution of severe quality incidents.

• Quality Control : Ensure testing and release/rejection of RM, PM, intermediates, and FG per SOPs and regulatory requirements. Provide resources, technical support and guidance to quality associates. Oversee stability studies and microbiological testing compliance. Approve method validation/verification documents.

• Quality Assurance: Ensure compliance as per site SOP for various systems: Handling of Market Complaints (Product Technical Complaints - PTCs), Change Control Process, Management of Self Inspections and Internal Audits, Investigation of Deviations, Investigation of Out of Specification (OOS) / Out of Trend (OOT) results, Corrective & preventive actions (CAPA). Approve Annual Product Quality Reviews. Approval of Batch Rework/Reprocessing in-line with Global standards. Ensure site Inspection readiness and management of all HA/GQA/Customer inspections. Ensure coordination from site in voluntary / mandatory product recalls as per Global standards. Ensure implementation of appropriate Quality Risk Management tools and the system. Ensure the system for Retention of documents/records as per applicable cGMP requirements. Ensure implementation of the system for the management of computerized systems. Ensure continuous improvement and Quality operations. Ensure to comply to the Sanofi Internal control requirements (ICT).

• Regulatory Compliance: Approve Master manufacturing and Laboratory Control documents required for registration purpose. Fulfil requirements of licenses from Local FDA, co-ordinate with various local and international regulatory inspections. Also represent Site Quality in front of Health Authorities. Monitor regulatory changes, new authority requirements in the EU, WHO, ANVISA, EAEU and other regulatory regions. Ensure that the GMP certifications, product permissions received at site are appropriately maintained. Decide on product quality event reportability and maintain the Site Master File.

• Quality Training Systems & Reporting: Ensure that the system for management of GMP training is in-place. Ensure adequate GMP training of site employees. Consolidate Quality Key Performance Indicators (KPIs) and present monthly reports to senior management.

• Capital & Budget Management: Monitor and control the revenue and capital budget of the quality department. Lead infrastructure upgrades, prepare revenue/capital budget requirements for the year and for the long-range plan. Also, monitor the expenditure with respect to the sanctioned budgets.

• Continuous Improvement Projects: Champion and drive continuous improvements in the department. Also work  closely with other departments and contribute to Company’s priorities in environment, safety, quality and customer service level.

• Product Transfer and New Projects: Support new Product transfer, sourcing cases and new Projects at Goa site in line with Site strategy.

• HSE: Drive and implement HSE systems, safe working conditions and maintain a culture of continuous improvement in the department. Train people on safety related aspect at work, ensure zero LTI and IWLT at workplace.

• People & Culture: Build and maintain a high-performance culture through effective leadership and talent development. Promote employee engagement, safety and well-being. Ensure workforce planning and succession management.

About you

Desired Experience and Qualification:

• Bachelors/ Master of Pharmacy or Masters in Science

• Minimum 15 years of Experience in Pharma including Quality Operations ,Quality Systems, Quality Control, Regulatory Compliance

• Exposure to working in matrixed environment with global processes & governance structures

• Practical knowledge of Global Compliance and Regulatory requirements, Industry guidelines (e.g. ICH guidelines), cGxP: Good Manufacturing Practice, Good Laboratory Practice, Good Distribution Practice and other guidelines, the regulations of supervisory authorities at local and international level FDA, EMA, etc.

• Experience interacting with regulatory agencies( Including USFDA) and health authority inspections is required

• Thorough knowledge of EHS requirements

• Good exposure to change management

• Project Management skills

• Experience in risk management and simplification/harmonization

• Good practice & understanding of new technologies & digital tools (including data analytical tools) 

• Experience in a cross-functional role (e.g., Production, Opex, Engineering) is a plus

• Strong track record in developing and managing medium sized teams

Desired Soft skills:

• Committed to Patients and full product quality

• Effective communication skills

• Effective negotiation and influencing skills

• Strong critical thinking / problem-solving skills to navigate ambiguous situations

• Ability to manage complexity effectively (shifting timelines, projects, priorities)

• Excellent  cross -functional collaboration and stakeholder Management

• Strategic Thinking

• Highly result oriented

• Growth mindset

• Inclusive style of leadership

• People Developer

Pursue progress, Discover extraordinary

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