Manager – Quality Compliance / Data Integrity

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
• 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

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 within the 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.

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.

Quality Assurance and Control Breakthroughs that change patients’ lives Research confirms what intuition tells us: that purpose-driven companies perform better, are more innovative, attract and retain the best people, and know how to unleash the power of those people. Pfizer’s purpose—Breakthroughs that change patients' lives—fuels everything we do and reflects our passion for building on our legacy as one of the greatest contributors of good to the world.

Each word in our purpose has meaning and reflects the value we strive to bring to patients and society:

“Breakthroughs” - These are the innovations, scientific and commercial, that we seek to deliver every day. All colleagues, regardless of role, level or location, strive for breakthroughs every day. “Change” - We want to do more than simply improve patients’ medical conditions; we want to dramatically change their lives for the better. “Patients’ lives” - We consider not only patients, but everyone they touch—including their families, caregivers, and friends—and everything they love to do. It’s an intentionally holistic view.

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.

Every decision we make and every action we take is done with the patient in mind—and to nurture an environment where breakthroughs can thrive.

Our Values

To fully realize Pfizer’s purpose, 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.

The “how” is represented by four simple, powerful values—courage, excellence, equity, and joy—that define our company and our culture.

Courage: Breakthroughs start by challenging convention, especially in the face of uncertainty or adversity. This happens when we think big, speak up, and are decisive.

Excellence: We can only change patients’ lives when we perform at our best together. This happens when we focus on what matters, agree who does what, and measure our outcomes.

Equity: We believe that every person deserves to be seen, heard, and cared for. This happens when we are inclusive, act with integrity, and reduce healthcare disparities.

Joy: We give ourselves to our work, but it also gives to us. We find joy when we take pride, recognize one another, and have fun.