Manager - Quality Compliance

Job Description

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.