Group Lead - DPQA

Dr. Reddy's Laboratories; Hyderabad; On-site; INR 3,500,000 - 5,500,000; Full time

Job summary

Dr. Reddy's Laboratories seeks an experienced leader to head Drug Product Quality Assurance, ensuring aseptic manufacturing compliance and end-to-end batch release oversight across the DPQA function.

The role requires 15–20 years in biopharma/aseptic environments with hands-on regulatory inspection experience, a strategic mindset, and strong cross-functional leadership to sustain quality culture and continuous improvement.

Qualifications

• M.Pharm / B.Pharm / M.Sc. in microbiology, biotechnology, biochemistry, or life sciences; advanced QA/Regulatory cert preferred.
• Experience 15–20 years in biopharmaceutical, sterile injectable, vaccine, or aseptic manufacturing environments.
• Minimum 5 years of leadership in Drug Product QA or Manufacturing QA.
• Hands-on experience supporting global regulatory inspections (USFDA, EMA, MHRA, ANVISA, PMDA, Health Canada or equivalent).

Responsibilities

• Provide QA oversight for aseptic DP manufacturing operations, including batch release decisions.
• Review deviations, CAPAs, change controls, and risk assessments; ensure compliance with cGMP.
• Lead quality systems management, inspections readiness, and continuous improvement initiatives.
• Oversee sterility assurance, CCS implementation, and contamination control strategies.
• Drive regulatory readiness, audits, health authority responses, and supplier oversight.

Skills

Leadership

Strategic thinking

Regulatory affairs

Communication

Risk assessment

Cross-functional collaboration

Education

M.Pharm / B.Pharm / M.Sc. Life Sciences

Advanced QA/Regulatory Certification

Tools

Quality Management Systems

Job description

To lead Drug Product Quality Assurance activities and provide strategic quality oversight for aseptic manufacturing operations, ensuring commercial and clinical drug product batches are manufactured, reviewed, and released in compliance with cGMP, global regulatory requirements, and internal quality standards. The incumbent shall be responsible for maintaining a state of control over manufacturing processes, sterility assurance programs, contamination control strategies, data integrity, inspection readiness, and quality systems while driving continuous improvement and fostering a strong quality culture across the organization.

Key Responsibilities

1. 1. Manufacturing Quality AssuranceProvide QA oversight for Drug Product manufacturing operations, including aseptic processing, filling, visual inspection, and packaging activities.Ensure compliance with cGMP, GDP, Data Integrity (ALCOA+), and regulatory requirements on the manufacturing shop floor.Review and approve batch manufacturing records and support timely batch disposition and release.Act as authorized QA representative for product disposition decisions.Drive real-time quality oversight and escalation of critical compliance issues.
2. 2. Batch Release & Product DispositionEnsure all quality and GMP requirements are fulfilled prior to batch release.Review deviations, investigations, CAPAs, change controls, and impact assessments associated with product batches.Support risk-based decision-making for batch release, rejection, reprocessing, or rework.Review and approve market complaint investigations, recalls, and mock recall reports.
3. 3. Validation & Qualification OversightProvide quality oversight for:Process ValidationCleaning ValidationAseptic Process Simulation (Media Fills)Equipment QualificationHold Time StudiesContinued Process Verification (CPV)Ensure validated state is maintained throughout the product lifecycle.Review and approve validation protocols, reports, and associated risk assessments.
4. 4. Quality Systems ManagementLead timely closure of:DeviationsInvestigationsCAPAsChange ControlsQuality Risk Assessments (QRM)Review and approve SOPs, protocols, reports, product quality reviews, and GMP documentation.Ensure effectiveness verification of CAPAs and continuous improvement initiatives.
5. 5. Sterility Assurance & Contamination ControlLead implementation and continuous improvement of the Contamination Control Strategy (CCS).Monitor aseptic practices, environmental monitoring trends, utilities, and cleanroom compliance.Ensure compliance with Annex 1, FDA, EMA, WHO, and other applicable regulatory expectations for sterile manufacturing.Support investigations related to microbial contamination, environmental excursions, and objectionable organism recoveries.Provide oversight for sterility assurance programs and contamination prevention activities.
6. 6. Regulatory Compliance & Inspection ReadinessMaintain a constant state of inspection readiness.Lead and support regulatory inspections, customer audits, due diligence audits, and self-inspections.Review audit observations and ensure timely implementation of remediation activities.Support preparation of regulatory submissions and health authority responses.Drive proactive compliance monitoring and risk mitigation across DP manufacturing operations.
7. 7. Product Quality ReviewLead preparation, review, and approval of Annual Product Quality Reviews (APQR/PQR).Ensure timely collection, analysis, and trending of quality metrics.Present quality trends, compliance risks, and improvement opportunities to site leadership.
8. 8. Vendor & External Manufacturing OversightSupport supplier qualification, contractor qualification, and quality agreement management.Review quality aspects of outsourced manufacturing, testing, and service activities.Participate in supplier audits and ongoing performance monitoring.
9. 9. Leadership & People DevelopmentLead, mentor, and develop the DPQA team.Build a culture of quality, accountability, compliance, and continuous improvement.Drive cross-functional collaboration with Manufacturing, QC, MSAT, Engineering, Validation, and Regulatory Affairs.Support succession planning and capability development within the QA organization.

Educational Qualification

• M.Pharm / B.Pharm / M.Sc. (Microbiology, Biotechnology, Biochemistry, Life Sciences) or equivalent.
• Advanced qualification or certification in Quality Assurance, Regulatory Affairs, or Pharmaceutical Management is preferred.
• Experience15-20 years of experience in Biopharmaceutical, Sterile Injectable, Vaccine, or Aseptic Manufacturing environments.
• Minimum 5 years of leadership experience in Drug Product Quality Assurance or Manufacturing Quality Assurance.
• Hands-on experience supporting global regulatory inspections including USFDA, EMA, MHRA, ANVISA, PMDA, Health Canada, or equivalent agencies.
• Strong experience in aseptic processing, contamination control strategy, sterility assurance, validation, and batch disposition.

Technical Competencies

• cGMP and Global Regulatory Requirements
• Data Integrity and Quality Systems
• Aseptic Processing and Annex 1 Compliance
• Sterility Assurance Programs
• Contamination Control Strategy (CCS)
• Process and Cleaning Validation
• Deviation, CAPA, Change Control, and QRM
• Product Quality Review (APQR/PQR)
• Regulatory Inspection Management
• Root Cause Investigation and Risk Assessment

Leadership Competencies

• Strong quality and compliance mindset
• Strategic thinking and business acumen
• Critical decision-making and risk-based judgment
• Team leadership and people development
• Cross-functional collaboration
• Stakeholder management and influencing skills
• Effective communication and coaching capabilities
• Strong drive for inspection readiness and operational excellence