Associate Manager - Quality Compliance

Pfizer; India; On-site; INR 1,200,000 - 2,400,000; Full time

Job summary

Pfizer is seeking an experienced Quality Assurance professional to ensure data integrity and regulatory compliance across GMP functions at an on-premise site in India. You will drive CAPAs, investigations, and market-complaint management while maintaining a culture of quality and continuous improvement.

The role involves collaborating with global regulators, leading data governance initiatives, and supporting inspections and audits to ensure product quality and patient safety.

Qualifications

• 8–12 years in Quality Assurance, Quality Compliance, Data Integrity, Market Complaints, or Quality Systems.
• Experience in regulated sterile manufacturing environments.
• Exposure to global regulatory inspections (US FDA, MHRA, EMA, WHO, TGA, Health Canada, etc.).
• Experience with eQMS, laboratory systems, and manufacturing systems is preferred.
• Bachelor's or Master's in Pharmacy, Pharma Sciences, Life Sciences, Chemistry, Biotechnology, or a related discipline.

Responsibilities

• Partner with Site Data Integrity Lead to promote good data management and Data Integrity culture across GxP.
• Support Data Integrity Governance programs per regulatory and corporate requirements.
• Conduct periodic Data Integrity walkthroughs across GMP areas and identify ALCOA gaps.
• Perform reviews of operations for Data Integrity compliance and remediation.
• Participate in Data Governance processes, training, and awareness initiatives.
• Investigations: participate in Data Integrity investigations, root cause analyses, and CAPA development.
• Prepare and present Data Integrity metrics and compliance reports for management.
• Market Complaints: manage receipt, evaluation, investigation, trending, and closure.
• Support Annual Product Reviews, recalls, field actions, and regulatory reporting.
• Quality Compliance & CI: support initiatives, inspections, audits, and cross-functional projects.

Skills

Data Integrity

Quality Assurance

CAPA

Regulatory Inspections

Root Cause Analysis

GxP Compliance

Education

Bachelor's or Master's in Pharmacy/Pharma Sciences/Life Sciences/Chemistry/Biotech/Microbiology

Tools

eQMS

Job description

**Use Your Power for Purpose**Pfizer is driven by an unwavering commitment to delivering safe and effective products to patients. Our science and risk-based compliant quality culture is both flexible and innovative, always putting the patient first. Your contributions will be vital and will have a direct impact on patient care, ensuring we deliver on our promise of quality and safety. **Qualifications:****Education*** Bachelor's or Master's Degree in Pharmacy, Pharmaceutical Sciences, Life Sciences, Chemistry, Biotechnology, Microbiology, or a related discipline.**Experience:*** 8–12 years of experience in Quality Assurance, Quality Compliance, Data Integrity, Market Complaints, or Quality Systems within the pharmaceutical industry.* Experience in regulated sterile manufacturing environments.* Exposure to global regulatory inspections (US FDA, MHRA, EMA, WHO, TGA, Health Canada, etc.).* Experience with eQMS, laboratory systems, and manufacturing systems is preferred.**Data Integrity Management*** Partner with the Site Data Integrity Lead to promote good data management practices and a strong Data Integrity culture across GxP functions.* Support implementation and maintenance of Data Integrity Governance programs in line with regulatory and corporate requirements.* Conduct periodic Data Integrity walkthroughs in Manufacturing, QC Laboratories, Warehouses, Utilities, Engineering, and other GMP areas.* Identify gaps related to ALCOA principles and drive appropriate CAPA implementation.* Perform periodic reviews of manufacturing and laboratory operations for Data Integrity compliance.* Support development of Data Governance processes, procedures, training programs, and awareness initiatives.* Monitor effectiveness of Data Integrity controls and remediation activities.* Participate in site and global Data Integrity forums to share best practices and continuous improvement initiatives.**Investigations & Compliance*** Participate in investigations related to Data Integrity concerns, compliance issues, and improper practices.* Conduct root cause analysis and support development of effective CAPAs.* Review CAPAs for adequacy, effectiveness, and timely implementation.* Verify effectiveness of corrective actions through follow-up assessments.* Prepare and present Data Integrity metrics, trends, and compliance reports for management review.**Market Complaints Management*** Manage receipt, evaluation, investigation, trending, and closure of product market complaints.* Coordinate cross-functional investigations and assess product quality impact.* Identify complaint trends and recommend corrective and preventive actions.* Ensure timely closure of complaints and associated CAPAs.* Support Annual Product Reviews, product recalls, field actions, and regulatory reporting activities, as applicable.**Quality Compliance & Continuous Improvement*** Support compliance initiatives related to Data Integrity, Market Complaints, CAPA, and Quality Systems.* Assist in regulatory inspections, customer audits, and inspection readiness activities.* Promote a culture of quality, integrity, and continuous improvement.* Participate in cross-functional projects to enhance compliance and product quality performance. Work Location Assignment: On Premise