Position – Position – Manager, Specialty Product 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 Manager – Specialty Product Quality & Safety to own the quality and safety framework for specialty

and higher-risk healthcare products. This is a dual-role position combining product quality assurance with proactive

product safety management.

The role will work across Product, Category, Pharmacy, Clinical, Operations, Supply Chain, Regulatory, Technology and

Customer Experience teams to ensure specialty products are sourced, stored, handled, dispensed, delivered and

experienced by customers in a manner that meets defined quality and safety standards.

The individual will identify product and process risks, establish controls, investigate quality and safety events, manage

complaints and CAPA, support supplier quality, and drive continuous improvement across the specialty product lifecycle.

Key Responsibilities

1. Specialty Product Quality Management

• Develop and implement quality standards and controls for specialty and high-risk products across the end-to-end product

lifecycle.

• Define critical quality requirements for sourcing, procurement, receiving, storage, inventory handling, dispensing, packing,

transportation, delivery and customer handover.

• Establish quality checkpoints and acceptance criteria for products and processes.

• Partner with Pharmacy, Supply Chain, Operations and Category teams to ensure adherence to approved product quality

requirements.

• Identify quality gaps, trends and recurring failures and drive systemic corrective actions.

• Support development and review of SOPs, work instructions, checklists and quality controls for specialty products.

2. Product Safety & Risk Management

• Establish a proactive product safety framework for specialty products and associated customer journeys.

• Conduct product and process risk assessments to identify potential hazards, failure modes and safety-critical controls.

• Use appropriate tools such as risk matrices, FMEA/JHA or equivalent structured methodologies based on the risk and

process.

• Identify critical-to-quality and critical-to-safety parameters and ensure appropriate controls are established.

• Assess safety risks associated with product handling, storage, temperature excursions, packaging, transportation,

dispensing and customer use.

• Ensure safety risks are assessed before introduction of new specialty products, services, vendors or significant process

changes.

• Maintain a product quality and safety risk register and track mitigation of high and unacceptable risks.

3. Product Complaints, Quality Events & Investigations

• Own the framework for receiving, triaging, investigating and closing product quality and safety complaints/events.

• Establish severity classification, escalation timelines and investigation requirements for quality and safety events.

• Lead investigation of significant product quality and safety events using structured Root Cause Analysis.

• Differentiate between product defect, process failure, handling error, supplier issue and customer-use factors.

• Drive CAPA and verify effectiveness of corrective and preventive actions.

• Identify recurring complaints and emerging product safety signals and escalate appropriately.

4. Supplier & Product Quality Assurance

• Partner with Procurement, Category and Supply Chain teams to establish supplier quality expectations for specialty

products.

• Support qualification and ongoing monitoring of critical suppliers based on product and patient/customer risk.

• Define quality requirements, documentation and controls expected from suppliers and partners.

• Track supplier-related quality incidents, deviations, complaints and CAPA.

• Participate in supplier reviews and audits for high-risk products or processes where required.

• Drive improvement plans for recurring supplier quality issues.

5. Storage, Cold Chain & Distribution Quality

• Establish quality and safety controls for specialty products requiring controlled storage or transportation.

• Monitor critical storage and transportation parameters and investigate excursions or deviations.

• Define escalation and disposition requirements for temperature excursions, damaged products, packaging failures and

other quality events.

• Partner with Supply Chain and Operations to strengthen handling, packing, transportation and delivery controls.

• Identify risks introduced during last-mile delivery and develop appropriate preventive controls.

6. Quality Systems, CAPA & Continuous Improvement

• Build and maintain a practical product quality management system for specialty products.

• Maintain quality event, deviation, complaint, CAPA and risk-management records.

• Track leading indicators such as complaint trends, deviations, excursion rates, repeat failures and CAPA effectiveness.

• Conduct risk-based quality reviews and audits of critical processes.

• Use data and trend analysis to identify systemic quality risks and prioritize interventions.

• Drive continuous improvement initiatives that improve both product quality and customer/patient safety.

7. Product Launch & Change Management

• Participate in new specialty product and service launches from a quality and safety perspective.

• Conduct or review quality and safety risk assessments before launch.

• Define quality gates, acceptance criteria, controls, monitoring plans and escalation mechanisms.

• Review proposed process, technology, packaging, vendor or operational changes for quality and safety impact.

• Ensure lessons from incidents, complaints and quality events are incorporated into future launches and process changes.

8. Cross-Functional Collaboration & Capability Building

• Work closely with Product, Pharmacy, Clinical, Category, Supply Chain, Operations, Regulatory, Technology and

Customer Experience teams.

• Translate technical quality and safety requirements into practical operational controls.

• Develop training and awareness for teams handling specialty products.

• Build capability among operational teams to identify quality risks, report events and follow critical controls.

• Represent Specialty Product Quality & Safety in relevant business and governance forums.

What We Are Looking For

• 5–8+ years of relevant experience in Product Quality, Quality Assurance, Healthcare Quality, Pharmaceutical Quality,

Medical Devices, Clinical Quality, Product Safety or a related field.

• Experience managing quality and/or safety for healthcare, pharmaceutical, diagnostics, medical devices, specialty

products or other regulated/high-risk products.

• Strong understanding of Quality Management Systems, risk management, CAPA, deviations, complaints and Root Cause

Analysis.

• Hands-on experience in product/process risk assessment and structured problem solving.

• Ability to translate quality and safety requirements into practical operational controls.

• Strong stakeholder management and cross-functional collaboration skills.

• Data-driven approach with the ability to identify trends and emerging quality or safety risks.

• High ownership, attention to detail and ability to work effectively in a fast-paced environment.

Preferred Qualifications

• Bachelor's or Master's degree in Pharmacy, Pharmaceutical Sciences, Life Sciences, Biotechnology, Biomedical

Engineering, Engineering, Healthcare or a related discipline.

• M.Pharm, Pharm.D, B.Pharm, M.Pharm, MSc Life Sciences or equivalent healthcare/product-quality qualification is

preferred.

• Experience in pharmaceutical, medical device, diagnostics, hospital, specialty pharmacy or healthcare product quality is

strongly preferred.

• Knowledge of GMP/GDP, GxP, pharmacovigilance or medical-device quality concepts is an advantage, depending on

product scope.

• Experience with ISO 9001, ISO 13485, ISO 14971 or other relevant quality/risk management standards is desirable.

• Training/certification in Root Cause Analysis, CAPA, FMEA, Risk Management, Quality Auditing or Lean/Six Sigma is an

advantage.

• Experience working with cold-chain or temperature-sensitive products is preferred.

Success in the Role

• Establish a scalable quality and safety framework for specialty products.

• Reduce product quality incidents, safety events, complaints and repeat failures.

• Ensure critical product and process risks are identified and appropriately controlled.

• Improve quality-event investigation, CAPA quality and effectiveness.

• Strengthen supplier quality and cold-chain/product handling controls where applicable.

• Ensure quality and safety are embedded into new product launches and process changes.

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 Manager – Specialty Product Quality & Safety to own the quality and safety framework for specialty

and higher-risk healthcare products. This is a dual-role position combining product quality assurance with proactive

product safety management.

The role will work across Product, Category, Pharmacy, Clinical, Operations, Supply Chain, Regulatory, Technology and

Customer Experience teams to ensure specialty products are sourced, stored, handled, dispensed, delivered and

experienced by customers in a manner that meets defined quality and safety standards.

The individual will identify product and process risks, establish controls, investigate quality and safety events, manage

complaints and CAPA, support supplier quality, and drive continuous improvement across the specialty product lifecycle.

Key Responsibilities

1. Specialty Product Quality Management

• Develop and implement quality standards and controls for specialty and high-risk products across the end-to-end product

lifecycle.

• Define critical quality requirements for sourcing, procurement, receiving, storage, inventory handling, dispensing, packing,

transportation, delivery and customer handover.

• Establish quality checkpoints and acceptance criteria for products and processes.

• Partner with Pharmacy, Supply Chain, Operations and Category teams to ensure adherence to approved product quality

requirements.

• Identify quality gaps, trends and recurring failures and drive systemic corrective actions.

• Support development and review of SOPs, work instructions, checklists and quality controls for specialty products.

2. Product Safety & Risk Management

• Establish a proactive product safety framework for specialty products and associated customer journeys.

• Conduct product and process risk assessments to identify potential hazards, failure modes and safety-critical controls.

• Use appropriate tools such as risk matrices, FMEA/JHA or equivalent structured methodologies based on the risk and

process.

• Identify critical-to-quality and critical-to-safety parameters and ensure appropriate controls are established.

• Assess safety risks associated with product handling, storage, temperature excursions, packaging, transportation,

dispensing and customer use.

• Ensure safety risks are assessed before introduction of new specialty products, services, vendors or significant process

changes.

• Maintain a product quality and safety risk register and track mitigation of high and unacceptable risks.

3. Product Complaints, Quality Events & Investigations

• Own the framework for receiving, triaging, investigating and closing product quality and safety complaints/events.

• Establish severity classification, escalation timelines and investigation requirements for quality and safety events.

• Lead investigation of significant product quality and safety events using structured Root Cause Analysis.

• Differentiate between product defect, process failure, handling error, supplier issue and customer-use factors.

• Drive CAPA and verify effectiveness of corrective and preventive actions.

• Identify recurring complaints and emerging product safety signals and escalate appropriately.

4. Supplier & Product Quality Assurance

• Partner with Procurement, Category and Supply Chain teams to establish supplier quality expectations for specialty

products.

• Support qualification and ongoing monitoring of critical suppliers based on product and patient/customer risk.

• Define quality requirements, documentation and controls expected from suppliers and partners.

• Track supplier-related quality incidents, deviations, complaints and CAPA.

• Participate in supplier reviews and audits for high-risk products or processes where required.

• Drive improvement plans for recurring supplier quality issues.

5. Storage, Cold Chain & Distribution Quality

• Establish quality and safety controls for specialty products requiring controlled storage or transportation.

• Monitor critical storage and transportation parameters and investigate excursions or deviations.

• Define escalation and disposition requirements for temperature excursions, damaged products, packaging failures and

other quality events.

• Partner with Supply Chain and Operations to strengthen handling, packing, transportation and delivery controls.

• Identify risks introduced during last-mile delivery and develop appropriate preventive controls.

6. Quality Systems, CAPA & Continuous Improvement

• Build and maintain a practical product quality management system for specialty products.

• Maintain quality event, deviation, complaint, CAPA and risk-management records.

• Track leading indicators such as complaint trends, deviations, excursion rates, repeat failures and CAPA effectiveness.

• Conduct risk-based quality reviews and audits of critical processes.

• Use data and trend analysis to identify systemic quality risks and prioritize interventions.

• Drive continuous improvement initiatives that improve both product quality and customer/patient safety.

7. Product Launch & Change Management

• Participate in new specialty product and service launches from a quality and safety perspective.

• Conduct or review quality and safety risk assessments before launch.

• Define quality gates, acceptance criteria, controls, monitoring plans and escalation mechanisms.

• Review proposed process, technology, packaging, vendor or operational changes for quality and safety impact.

• Ensure lessons from incidents, complaints and quality events are incorporated into future launches and process changes.

8. Cross-Functional Collaboration & Capability Building

• Work closely with Product, Pharmacy, Clinical, Category, Supply Chain, Operations, Regulatory, Technology and

Customer Experience teams.

• Translate technical quality and safety requirements into practical operational controls.

• Develop training and awareness for teams handling specialty products.

• Build capability among operational teams to identify quality risks, report events and follow critical controls.

• Represent Specialty Product Quality & Safety in relevant business and governance forums.

What We Are Looking For

• 5–8+ years of relevant experience in Product Quality, Quality Assurance, Healthcare Quality, Pharmaceutical Quality,

Medical Devices, Clinical Quality, Product Safety or a related field.

• Experience managing quality and/or safety for healthcare, pharmaceutical, diagnostics, medical devices, specialty

products or other regulated/high-risk products.

• Strong understanding of Quality Management Systems, risk management, CAPA, deviations, complaints and Root Cause

Analysis.

• Hands-on experience in product/process risk assessment and structured problem solving.

• Ability to translate quality and safety requirements into practical operational controls.

• Strong stakeholder management and cross-functional collaboration skills.

• Data-driven approach with the ability to identify trends and emerging quality or safety risks.

• High ownership, attention to detail and ability to work effectively in a fast-paced environment.

Preferred Qualifications

• Bachelor's or Master's degree in Pharmacy, Pharmaceutical Sciences, Life Sciences, Biotechnology, Biomedical

Engineering, Engineering, Healthcare or a related discipline.

• M.Pharm, Pharm.D, B.Pharm, M.Pharm, MSc Life Sciences or equivalent healthcare/product-quality qualification is

preferred.

• Experience in pharmaceutical, medical device, diagnostics, hospital, specialty pharmacy or healthcare product quality is

strongly preferred.

• Knowledge of GMP/GDP, GxP, pharmacovigilance or medical-device quality concepts is an advantage, depending on

product scope.

• Experience with ISO 9001, ISO 13485, ISO 14971 or other relevant quality/risk management standards is desirable.

• Training/certification in Root Cause Analysis, CAPA, FMEA, Risk Management, Quality Auditing or Lean/Six Sigma is an

advantage.

• Experience working with cold-chain or temperature-sensitive products is preferred.

Success in the Role

• Establish a scalable quality and safety framework for specialty products.

• Reduce product quality incidents, safety events, complaints and repeat failures.

• Ensure critical product and process risks are identified and appropriately controlled.

• Improve quality-event investigation, CAPA quality and effectiveness.

• Strengthen supplier quality and cold-chain/product handling controls where applicable.

• Ensure quality and safety are embedded into new product launches and process changes.