Supply Operations Quality Market Lead (Team Lead)

Overview

Lead end-to-end Quality oversight and leadership of supply operations in India, including product release, distribution, product quality management and vendor quality management, and act as the Responsible Person for the relevant India licences.

What you'll do

• Provide senior Quality leadership and end-to-end quality oversight for the India market, with accountability for 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.
• 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, 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.
• 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.
• Oversee GMP/GDP and Quality Operations in the market and be accountable for Release for Distribution of imported products in India and export markets.
• Lead investigation and resolution of market quality issues, root cause analysis, and sustainable CAPAs for product quality issues.
• Lead cross-functional Quality decisions and actions to manage product risks and support continuity of supply.
• Ensure product complaints are managed in compliance with Pfizer procedures and global Quality systems.
• Provide Quality leadership and oversight for market actions, recalls, quarantine alerts and product returns.
• Lead and develop a high-performing India SOQ team with clear accountabilities and objectives, providing regular coaching, feedback and performance management.
• Build team capability through development planning, knowledge sharing and succession planning.
• Represent Quality within PCO leadership discussions and business forums, serving as primary Quality point of contact for India PCO.
• Enable market launches, product lifecycle management activities and supply continuity initiatives.
• Partner with global and regional teams to ensure compliance and operational excellence.
• Provide quality expertise in business transformation and process improvement initiatives.

What you'll need

• Bachelor's degree or MBA / MS degree in Pharmacy.
• 10-15 years of relevant experience in the pharmaceutical industry in a Quality role (must have).
• People management experience is required.
• A minimum of 5 years leading and demonstrated success in developing a team of colleagues (must have).
• Extensive GMP/GDP knowledge; trained and experienced in the total application of GMP/GDP licensing and Marketing Authorization compliance requirements.
• Extensive experience with quality systems, investigations, CAPA management, audits and inspections.
• Extensive experience in managing cross-functional stakeholders, with strong negotiation and influencing skills with internal senior stakeholders and external parties.
• Demonstrated insight and understanding of stakeholder needs and business requirements.
• Strong analytical and decision-making skills; extensive experience in leading complex projects.
• Extensive experience with demonstrated ability to communicate effectively.
• Experience interacting with health authorities, regulatory agencies and external stakeholders.
• High level of self-integrity and ethical conduct.
• Strong planning and organisation skills.
• A track record of continuous improvement and balancing efficiencies and effectiveness in processes.

Nice to have

• MBA degree or PhD degree.
• Proven record of innovation and ability to influence senior leaders to drive organizational change.
• Experience using common AI tools, including generative technologies such as ChatGPT or Microsoft Copilot, to support problem solving and enhance productivity.
• Demonstrated curiosity for exploring how AI technologies can improve outcomes and operational efficiency.
• Understanding of Responsible AI principles, including ethical use, governance, transparency and risk management.

Details

• Work location: Mumbai, India.
• Work mode: Hybrid.