Group Lead - DPQA

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. Manufacturing Quality Assurance

Provide 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. Batch Release & Product Disposition

Ensure 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. Validation & Qualification Oversight

Provide quality oversight for: Process Validation

Cleaning Validation

Aseptic Process Simulation (Media Fills)

Equipment Qualification

Hold Time Studies

Continued Process Verification (CPV)

Ensure validated state is maintained throughout the product lifecycle.

Review and approve validation protocols, reports, and associated risk assessments.

4. Quality Systems Management

Lead timely closure of: Deviations

Investigations

CAPAs

Change Controls

Quality 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. Sterility Assurance & Contamination Control

Lead 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. Regulatory Compliance & Inspection Readiness

Maintain 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. Product Quality Review

Lead 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. Vendor & External Manufacturing Oversight

Support 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. Leadership & People Development

Lead, 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.

Experience

15-20 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

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.

Our Work Culture

Ask any employee at Dr. Reddy’s why they come to work every day and they’ll say, because Good Health Can’t Wait. This is our credo as well as the guiding principle behind all our actions. We see healthcare solutions not only as scientific formulations, but as a means to help patients lead healthier lives, and we’re always attuned to the new and the next to empower people to stay fit. And to do this, we foster a culture of empathy and dynamism. People are at the core of our journey over the last few decades. They have been supported by an enabling environment that buoys individual ability while fostering teamwork and shared success. We believe that when people with diverse skills are bound together by a common purpose and value system, they can make magic.

Equal Opportunity Employer

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against based on disability.

For more details, please visit our career website at https://careers.drreddys.com/#!/