Associate Manager - Quality Compliance

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:

• 5-10 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