Jobs / India / Pfizer INC

Pfizer INC

Supply Operations Quality Market Lead (Team Lead)

India - Mumbai Posted today

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Skills this job asks for

LeadershipComplianceSupply chainRisk managementLogisticsAudit

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About the role

The Supply Operations Quality (SOQ) Lead is accountable for end-to-end Quality leadership and oversight of supply operations in India, including product release, distribution, product quality management and vendor quality management. The role ensures regulatory compliance, inspection readiness and the supply of compliant products into India and relevant neighbouring markets.   As the primary Quality point of contact for the India PCO , the role provides direction on Quality matters, influences key business decisions, leads the escalation and resolution of significant Quality issues, and leads and develops the India SOQ team . It partners with Commercial, Regulatory Affairs, Medical, Global Supply Chain, External Supply Operations Quality and PGS sites to manage significant Quality risks and support continuity of supply.   The role leads the delivery of India Marketing Authorisation Holder Quality responsibilities and acts as the Responsible Person for the relevant India licences, ensuring product release, storage and distribution comply with regulatory requirements, Pfizer Quality Standards, Good Manufacturing Practice and Good Distribution Practice requirements. What You Will Achieve Quality Leadership & Governance • Provide senior Quality leadership end-to-end quality oversight for the India market, with accountability for the effectiveness of market quality governance, compliance, risk management and quality decision-making. • Lead quality management reviews and governance forums; ensuring significant Quality risks, trends and issues are assessed, escalated and addressed. • Establish a consistent, risk-based approach to Quality decisions and issue management across the India market. • Ensure implementation and maintenance of global and functional procedures, Pfizer Quality Standards and supporting Quality processes. • Review Quality performance, including metrics, trends and emerging risks, and drive necessary improvement actions. • Maintain oversight of Quality system effectiveness, training compliance and commitments arising from inspections, audits, deviations and corrective and preventive actions.   2. Regulatory & Compliance Excellence • Act as the primary Quality representative for Pfizer India and the Good Distribution Practice Responsible Person for the relevant India licenses . • Ensure compliance with local regulatory requirements, Pfizer Quality Standards and Good Manufacturing Practice and Good Distribution Practice requirements. • Maintain inspection readiness and lead Quality support for health authority inspections and internal audits. • Lead Quality-related interactions with local health authorities, in partnership with the relevant functions. • Provide country-level direction and oversight for Quality compliance matters, ensuring effective coordination across the relevant Quality teams. • Ensure timely and effective corrective and preventive actions following audits, inspections and significant Quality events, including verification of their effectiveness and sustainability.   3. Suppliers, Partner & Distributor Oversight • Provide market-level oversight of Quality activities relating to suppliers, distributors, third-party logistics providers and commercial partners. • Work with the relevant Quality teams to ensure supplier risks and performance issues are identified, escalated, and addressed. • Drive supplier performance improvement through effective governance, Quality agreements, performance metrics and risk-based oversight. • Ensure supplier qualification and audit activities are completed in line with regulatory requirements, Pfizer Quality Standards and established procedures   4. Product Quality Management • Overseeing GMP/GDP and Quality Operations in the market and accountable for

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