Pfizer

Associate Manager - Quality Compliance

Posted 3 Days Ago

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Vizag, Vishākhapatnam, Andhra Pradesh, IND

In-Office

Senior level

Artificial Intelligence • Healthtech • Machine Learning • Natural Language Processing • Biotech • Pharmaceutical

We’re in relentless pursuit of breakthroughs that change patients’ lives.

The Role

Lead data integrity governance and compliance for GMP operations. Conduct data integrity walkthroughs, investigations, root cause analysis, and CAPA management. Manage market complaints lifecycle, coordinate cross-functional investigations, and support regulatory inspections, audits, and continuous improvement initiatives.

Summary Generated by Built In

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
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

Skills Required

Bachelor's or Master's Degree in Pharmacy, Pharmaceutical Sciences, Life Sciences, Chemistry, Biotechnology, Microbiology, or related discipline
8-12 years' 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
Work location on premise (on-site)

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The Company

HQ: New York, NY

121,990 Employees

Year Founded: 1848

What We Do

Our purpose ensures that patients remain at the center of all we do. We live our purpose by sourcing the best science in the world; partnering with others in the healthcare system to improve access to our medicines; using digital technologies to enhance our drug discovery and development, as well as patient outcomes; and leading the conversation to advocate for pro-innovation/pro-patient policies.

Why Work With Us

We are the inventors, the problem solvers, the big thinkers — those who surmount any hurdle to deliver breakthrough medicines to the people who are counting on them the most.