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 the 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.
5. People Leadership & Talent Development
- Lead and develop a high-performing India SOQ team with clear accountabilities and objectives.
- Provide regular coaching, feedback, and performance management.
- Build team capability through development planning, knowledge sharing, and succession planning.
- Foster an inclusive and collaborative working environment that supports accountability and effective decision-making
6. Business Partnership and strategic support
- Represent Quality within the PCO leadership discussions and business forums.
- Serve as the 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
Here Is What You Need (minimum requirements)
- Bachelors degree or MBA / MS Degree in Pharmacy
- 10-15 years of relevant experience in the pharmaceutical industry in a Quality role is a must
- People Management experience is required. Strong leadership skills in managing a team and ability to engage and develop direct reports; a minimum of 5 years leading and demonstrated success in developing a team of colleagues is a must
- 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, strong negotiation and influencing skills with internal senior stakeholders and external parties
- Demonstrated insight and understanding of stakeholders need and business requirements
- Strong analytical skills 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
Bonus Points If You Have (Preferred Requirements)
- 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
Work Location Assignment: Hybrid
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
To learn more about acceptable and prohibited uses of AI during the recruitment process, please review our candidate AI-use guidelines available on Pfizer Careers.
Quality Assurance and Control