Pfizer Jobs

Manager - Quality Compliance

Pfizer

Manager - Quality Compliance

Posted 6 Hours Ago

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Vizag, Vishākhapatnam, Andhra Pradesh, IND

In-Office

Expert/Leader

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

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

The Role

Lead site quality compliance with focus on Data Integrity governance, investigations, product complaints, CAPA effectiveness, inspection readiness, and continuous improvement. Partner with cross-functional teams to assess risks, drive corrective actions, monitor effectiveness, deliver training, and present compliance metrics to leadership to ensure GMP and regulatory adherence in sterile pharmaceutical operations.

Summary Generated by Built In

Use Your Power for Purpose
Every day, everything we do is driven by an unwavering commitment to delivering safe and effective products to patients. Our quality culture, which is both science and risk-based, is designed to be flexible, innovative, and customer-oriented. Whether your role involves development, maintenance, compliance, or analysis through research programs, your contribution is crucial and will have a direct impact on patients. Our dedication to quality and safety ensures that we consistently meet the highest standards, making a meaningful difference in the lives of those we serve.
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 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.

Education / Qualification

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.
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

Minimum 10 years of experience in Quality Assurance, Quality Compliance, Data Integrity, Investigations or Quality Systems within the pharmaceutical industry (Sterile).
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.
Bachelor's or master's degree in pharmacy, Pharmaceutical Sciences, Life Sciences or a related discipline.
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

What the Team is Saying

Pfizer Compensation & Benefits Highlights

Healthcare Strength — Official materials describe comprehensive medical, dental, vision, and mental-health support, plus fertility/family‑building and transgender‑inclusive coverage; eligible Pfizer medications are noted as available at no cost in U.S. plans. Wellness resources such as telehealth and preventative programs are also emphasized.
Retirement Support — Company documents highlight a 401(k) with matching contributions plus an additional Retirement Savings Contribution beyond the match. Financial planning support and company‑paid life and disability insurance further bolster long‑term security.
Leave & Time Off Breadth — Corporate pages and job postings describe paid vacation and holidays, caregiver leave, and paid parental leave for both parents. Materials also note that details can vary by role and location.

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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.