Associate Manager - Quality Compliance

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.

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Quality Assurance and Control