Position – Associate Manager – Pharma Quality & Safety

Function: Quality & Safety Location: Gurgaon

About Tata 1mg

Tata 1mg is India's leading consumer healthcare platform. Our mission is to make healthcare accessible, understandable and affordable for every Indian. We operate across ePharmacy, eDiagnostics, eConsulting, offline stores and healthcare partnerships. About the Role

We are looking for a strong quality and safety leader to build and drive the Pharma Quality & Safety

charter across Tata 1mg. The role will proactively manage quality and patient-safety risks across

pharmacy operations, medicines, diagnostics and services, while establishing governance, risk

assessment, Good Distribution/Storage Practices (GDP/GSP), deviation and CAPA management, and

quality-by-design practices. This is a build-and-scale leadership role across Pharmacy Operations, Warehousing & Distribution, Retail, Cold Chain, Regulatory Affairs, Pharmacovigilance and other customer-facing healthcare services. 1. Enterprise Quality & Safety Strategy & Governance

• Develop and implement the enterprise Pharma Quality & Safety strategy. • Establish quality standards, policies, minimum controls, governance forums and escalation

mechanisms. • Define quality KPIs, leading and lagging indicators and an enterprise quality scorecard. • Maintain visibility of critical quality and product-safety risks and provide regular updates to senior

leadership. 2. Risk Assessment & Quality Risk Management • Build and institutionalize a standardized Quality Risk Management (QRM) framework. • Identify hazards and assess risks associated with sourcing, storage, dispensing, delivery, temperature-sensitive products and services. • Lead or oversee risk assessments for critical and high-risk activities across Pharmacy, Warehousing, Cold Chain, Retail and Delivery operations. • Ensure risk assessments are completed before new products, services, processes, facilities, equipment or significant operational changes. • Apply the Hierarchy of Controls to drive elimination, substitution, engineering and administrative

controls. • Establish risk acceptance criteria and escalation mechanisms for high and unacceptable risks. • Maintain an enterprise Quality Risk Register with risk owners, mitigation plans, timelines and

residual-risk ratings. • Review assessments following deviations, recalls, near misses, process changes, regulatory

changes or emergence of new hazards. • Use risk assessment outputs to prioritize audits, training, CAPA, quality investments and

operational interventions.

• Build capability within business teams and Quality Champions to conduct effective risk

assessments. 3. Deviation, Complaint & Quality Event Management • Establish a standardized enterprise-wide framework for deviations, complaints, adverse events

and quality observations. • Define severity classification, reporting timelines, escalation thresholds and investigation

requirements. • Lead investigations of critical and high-severity quality events and ensure robust Root Cause

Analysis (RCA). • Drive CAPA implementation and independently verify corrective-action effectiveness. • Identify repeat and systemic failures and ensure enterprise-level interventions. • Establish a Quality Alert and Recall management mechanism, including product recalls and market

withdrawals. 4. Pharmacy & Product Quality

• Develop the pharmacy quality framework across warehouses, stores, dark stores and delivery

operations. • Establish standards for Good Storage Practices (GSP), Good Distribution Practices (GDP), cold- chain integrity, expiry management and near-expiry controls. • Ensure quality induction, competency assessment and refresher training for employees and

relevant partners. • Identify high-risk activities (e.g. Schedule H/H1/X, narcotics, cold-chain medicines) and ensure

appropriate controls before work begins. • Develop and lead a network of Quality Champions. 5. Product & Service Safety

• Establish quality and safety controls across the end-to-end customer and patient journey. • Identify and assess safety risks associated with products, processes, services and customer

interactions, including dispensing and medication-safety errors. • Partner with Product, Technology, Clinical, Pharmacovigilance and Operations teams to

incorporate Quality & Safety by Design. • Establish mechanisms to identify, investigate and mitigate product/service-related quality events

and complaints. • Embed quality controls into SOPs, technology workflows, training and operational processes. • Conduct quality risk assessments for new launches, significant process changes and high-risk

services. 6. Audits, Assurance & Regulatory Compliance

• Develop a risk-based annual quality audit and assurance programme. • Conduct or oversee quality audits and assessments across critical locations, processes and

operations.

• Identify gaps between documented processes and actual execution against GMP/GDP/GSP and

applicable Drugs & Cosmetics Act/Rules requirements. • Track critical findings, corrective actions and closure effectiveness. • Benchmark Tata 1mg quality practices against relevant industry and healthcare/pharma regulatory

standards. • Serve as the primary interface for regulatory and statutory quality inspections. 7. Quality Culture & Capability

• Build a culture where quality and patient safety is everyone's responsibility. • Develop role-specific quality training and awareness programmes. • Build and empower Quality Champions across the organization. • Establish proactive reporting of quality issues, near misses and unsafe conditions. • Promote a learning-oriented and accountable quality culture. • Communicate quality alerts, trends, learnings and good practices. 8. Cross-Functional Leadership

• Partner with Operations, Pharmacy, Supply Chain, Retail, HR, Facilities, Clinical, Regulatory Affairs, Pharmacovigilance, Product, Technology, Legal and Business teams. • Influence senior stakeholders to prioritize quality and safety risks and implement sustainable

controls. • Participate in governance for new products, services, facilities, processes and major operational

changes. • Represent Quality & Safety in relevant business and leadership reviews. What We Are Looking For • 3-5 years of experience in Pharma Quality, Quality Assurance, GMP/GDP Compliance, Regulatory

Affairs, Pharmacovigilance, Risk Management, Operations Excellence or a related field. • Experience managing quality across multiple locations, functions and operational environments. • Strong experience in quality risk management, deviation/CAPA management, root cause analysis

and quality audits. • Ability to build quality frameworks and governance systems from the ground up. • Experience in pharmacy, healthcare, diagnostics, hospitals, logistics, warehousing, retail, pharmaceutical manufacturing or other regulated environments is preferred. • Strong understanding of leading and lagging quality indicators. • Ability to influence senior stakeholders and drive action without relying solely on formal authority. • Strong analytical, problem-solving and decision-making capabilities. • Excellent communication and presentation skills. • High ownership, strong judgement and ability to operate effectively in a fast-paced and

ambiguous environment.

Preferred Qualifications • Bachelor's degree in Pharmacy (B.Pharm), Pharmaceutical Sciences, Life Sciences or a related

discipline; M.Pharm preferred. • Professional qualification in Quality Assurance, Regulatory Affairs or Pharmaceutical Quality

Management. • Certification in GMP, GDP, Quality Risk Management (ICH Q9), Root Cause Analysis or Process

Safety. • Experience with pharmacovigilance or clinical safety frameworks. • Experience with ISO 9001, ISO 13485, WHO-GMP, Schedule M or equivalent management systems. • Experience implementing enterprise quality management systems across distributed operations. Success in the Role

• Establish a scalable enterprise quality management framework. • Ensure critical and high-risk activities are systematically identified and covered through risk

assessments. • Reduce high and unacceptable residual quality risks. • Improve deviation and complaint reporting and investigation quality. • Reduce repeat and high-severity quality events through systemic interventions. • Improve CAPA closure and effectiveness. • Embed quality and safety into new products, services, processes and operational changes. • Build a strong Quality Champion network and measurable improvement in quality culture. Why Join Us

This is an opportunity to build the Pharma Quality & Safety function for a leading consumer healthcare

platform. The role provides enterprise-wide exposure across pharmacy, healthcare, diagnostics, supply

chain, retail, technology and field operations, with the opportunity to influence how Tata 1mg grows