Manager

Darwinbox Digital Solutions Pvt. Ltd.; Gurugram District; On-site; INR 1,500,000 - 2,500,000; Full time

Job summary

Tata 1mg is seeking a Manager for Specialty Product Quality & Safety to own the quality and safety framework for specialty and high‑risk healthcare products. This role collaborates across Pharmacy, Clinical, Compliance, and Supply Chain to ensure safe sourcing, storage, handling, and delivery.

The candidate will lead investigations, CAPA, and continuous improvement across the product lifecycle. The position emphasizes proactive risk management, supplier quality oversight, and quality systems

Qualifications

• 5–8+ years of relevant experience in product quality, quality assurance or healthcare quality.
• Experience managing quality and safety for healthcare, pharmaceutical, diagnostics, medical devices or other regulated/high‑risk products.
• Strong understanding of Quality Management Systems, risk management, CAPA, deviations, complaints and Root Cause Analysis.
• 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.

Responsibilities

• Develop and implement quality standards for specialty products across the end‑to‑end lifecycle.
• Define critical quality requirements for sourcing, storage, dispensing, packing, transport and delivery.
• Establish quality checkpoints and acceptance criteria for products and processes.
• Collaborate with Pharmacy, Supply Chain, Operations and Category teams to ensure adherence to quality requirements.
• Identify quality gaps, trends and recurring failures and drive corrective actions.
• Support SOPs, work instructions, checklists and quality controls for specialty products.
• Establish a proactive product safety framework and conduct risk assessments.
• Identify hazards, failure modes and safety controls using structured methodologies.
• Define critical quality and safety parameters and ensure appropriate controls are in place.
• Assess safety risks in handling, storage, temperature excursions, packaging, transport and use.
• Ensure safety assessments for new products, services, vendors or process changes.
• Maintain a risk register and track mitigation of high risks.
• Own the framework for receiving, triaging, investigating and closing quality and safety complaints/events.
• Set severity classifications, escalation timelines and investigation requirements.
• Lead RCA investigations and verify effectiveness of CAPA.
• Differentiate between defects, process failures, handling errors and customer use factors.
• Drive CAPA and ensure sustained improvements.
• Identify recurring complaints and signal emerging safety issues.
• Partner with Procurement and Supply Chain to define supplier quality expectations.
• Support supplier qualification and monitoring for high‑risk products.
• Define quality requirements and controls from suppliers.
• Track supplier quality incidents, deviations and CAPA.
• Participate in supplier reviews and audits when required.
• Drive improvement plans for recurring supplier issues.
• Establish quality and safety controls for cold chain and controlled storage.
• Monitor storage/transport parameters and investigate excursions.
• Define escalation and disposition for temperature excursions and packaging failures.
• Collaborate with Supply Chain to strengthen handling and delivery controls.
• Identify risks during last‑mile delivery and implement preventive controls.
• Build and maintain a practical quality management system for specialty products.
• Maintain records for quality events, deviations, complaints, CAPA and risk management.
• Track leading indicators and CAPA effectiveness.
• Conduct risk-based quality reviews and audits of critical processes.
• Use data to identify systemic quality risks and prioritize interventions.
• Drive continuous improvement in product quality and safety.
• Support launches with quality risk assessments and gates.
• Review changes for quality and safety impact and ensure lessons learned are applied.
• Represent Quality & Safety in governance forums.
• Ensure training and capability building across teams.

Skills

Quality management

CAPA

Risk assessment

Root cause analysis

Stakeholder management

Cross-functional collaboration

Data-driven

Attention to detail

Education

Bachelor's or Master's degree in Pharmacy or Life Sciences

M.Pharm, Pharm.D, or equivalent

Job description

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 elevate 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.

Job Snapshot

Updated Date

03-09-2026

Job ID

JOB_ID3543

Department Hierarchy

Institutional Quality

Location