Manager - Quality Compliance

Pfizer, S.A. de C.V; India; On-site; INR 3,000,000 - 6,000,000; Full time

Job summary

Pfizer is seeking a seasoned Manager – Quality Compliance / Data Integrity to strengthen site quality programs, govern data integrity, investigations, CAPA and inspection readiness across GMP areas, manufacturing, QC labs, warehouses, and utilities.

You will partner with cross‑functional teams and site leadership to ensure compliance with US FDA, MHRA, EMA and other regulatory requirements, train staff, monitor metrics, and lead continuous improvement initiatives that protect patient safety.

Qualifications

• Minimum 10 years in Quality Assurance, Quality Compliance, Data Integrity or related Quality Systems in pharma (Sterile).
• Experience in regulated sterile manufacturing environments.
• Exposure to global regulatory inspections (US FDA, MHRA, EMA, WHO, TGA, Health Canada).
• Experience with eQMS and lab/manufacturing systems preferred.

Responsibilities

• Strengthen site quality compliance programs with Data Integrity governance.
• Lead investigations, complaints, CAPA, and inspection readiness activities.
• Partner with cross‑functional teams to ensure GMP/regulatory compliance.
• Promote culture of quality, integrity, and continuous improvement.
• Design and deliver Data Integrity training and capability development.

Skills

Data Integrity & ALCOA Compliance

Regulatory Inspection Readiness

Quality Metrics & Trend Analysis

Cross-functional Collaboration

Technical Writing & Reporting

Training & Knowledge Sharing

Education

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

Tools

eQMS

Laboratory systems

Manufacturing systems

Job description

We’re in relentless pursuit of breakthroughs that change patients’ lives. We innovate every day to make the world a healthier place.

To fully realize Pfizer’s purpose – Breakthroughs that change patients’ lives – we have established a clear set of expectations regarding “what” we need to achieve for patients and “how” we will go about achieving those goals.

Pfizer Global Supply proudly shoulders the responsibility of manufacturing and distributing our wide-ranging pharmaceutical products.

Pfizer offers competitive compensation and benefits programs designed to meet the diverse needs of our colleagues.

Transforming Delivery of high quality products

Pfizer, We are one

PGS - Manufacture the Future

Every day, everything we do is driven by an unwavering commitment to delivering safe and effective products to patients. Our quality culture, which is both science and risk-based, is designed to be flexible, innovative, and customer-oriented. Whether your role involves development, maintenance, compliance, or analysis through research programs, your contribution is crucial and will have a direct impact on patients. Our dedication to quality and safety ensures that we consistently meet the highest standards, making a meaningful difference in the lives of those we serve.

Role Summary

The Manager – Quality Compliance / Data Integrity will be responsible for supporting and strengthening site quality compliance programs with a focus on Data Integrity governance, investigations, product complaints, CAPA effectiveness, inspection readiness, and continuous improvement. The role will partner with cross-functional teams and site leadership to ensure compliance with applicable GMP, regulatory, and corporate requirements while promoting a strong culture of quality, integrity, and accountability.

What You Will Achieve

In this role, you will:

Data integrity program:

• 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.
• Conduct periodic Data Integrity assessments, walkthroughs, and risk evaluations across Manufacturing, QC Laboratories, Warehouse, Engineering, Utilities, and other GMP functions.
• 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.
• Present Data Integrity trends, metrics, risk assessments, and compliance status updates to site leadership through Quality Management Review.

Investigations, Product Complaints and CAPA

• Lead and participate in investigations or quality compliance observations.
• Manage receipt, evaluation, investigation, trending, and closure of product market complaints.
• Perform detailed root cause analysis using scientific and risk-based methodologies to identify true root causes and contributing factors.
• Support Annual Product Reviews, product recalls, field actions, and regulatory reporting activities, as applicable
• Develop, review, and approve corrective and preventive action (CAPA) plans to ensure sustainable remediation of identified issues.
• Monitor CAPA implementation timelines, evaluate effectiveness, and ensure closure of recurring or systemic issues.
• Conduct effectiveness checks and trend analyses to verify the long-term success of corrective actions.
• Escalate critical compliance risks, recurring trends, and systemic vulnerabilities to site leadership and Quality Management Review forums

Quality Compliance and 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.

Training and Capability Building

• Designing and expanding training and development programs based on the needs of the organization and the individual with respect to Data Integrity.
• Adopt appropriate training methodologies and deliver effective Data Integrity and quality compliance training to site colleagues.

Required Skills and Competencies

• Data Integrity & ALCOA Compliance
• Regulatory Inspection Readiness
• Quality Metrics & Trend Analysis
• Cross-functional Collaboration
• Technical Writing and Report Preparation
• Training & Knowledge Sharing

Here Is What You Need (Minimum Requirements)

Required Experience

• Minimum 10 years of experience in Quality Assurance, Quality Compliance, Data Integrity, Investigations or Quality Systems withinthe pharmaceutical industry (Sterile).
• Must have 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.

Education / Qualification

• Bachelor's or master's degree in pharmacy, Pharmaceutical Sciences, Life Sciences or a related discipline.

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

To learn more about acceptable and prohibited uses of AI during the recruitment process, please review our candidate AI‑use guidelines available on Pfizer Careers .

Quality Assurance and Control