Manager - Quality Compliance

• 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.

• 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

• 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.

• 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.

• Data Integrity & ALCOA Compliance
• Investigation Management
• Regulatory Inspection Readiness
• Risk Assessment & Risk Management
• Quality Metrics & Trend Analysis
• Cross-Functional Collaboration
• Leadership & Influencing Skills
• Technical Writing and Report Preparation
• Training & Knowledge Sharing

• 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.

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

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