Job Description

Role summary
The Engineering Compliance & Investigation Manager partners with the Engineering Lead to ensure alignment with cGMP, cGEP, and regulatory standards. The role leads internal audits, drives quality culture, and oversees engineering quality metrics. It provides direction for maintenance processes using EAMS, ensuring compliance, training, and robust documentation. Strong leadership in coaching, mentoring, and cross-functional collaboration is essential to sustain and elevate engineering compliance.
Role Responsibilities
Compliance Management

• Ensure adherence to quality systems, safety protocols, and regulatory guidelines.
• Review and approve change controls, documents, and procedures.
• Support root cause analysis, CAPA implementation, and timely closure of quality records.
• Ensure readiness for audits and timely responses to observations.
• Implement Pfizer Quality Standards (PQS) and ensure training completion.

Investigation Management

• Leading structured investigations, equipment failures, and non-conformances, ensuring root cause identification and alignment with cGMP and regulatory expectations.
• Applying structured problem-solving methodologies such as 5 Whys, Fishbone (Ishikawa) diagrams, Pareto analysis, and FMEA to drive data-based decision-making and eliminate recurring issues.
• Monitoring and trending deviation data to identify systemic issues, recurring failure modes, and compliance risks. Leveraging dashboards and quality metrics to prioritize focus areas.
• Translating investigation insights into actionable improvement projects. Leading cross-functional teams to implement continuous improvement initiatives that enhance equipment reliability, reduce downtime, and strengthen compliance.
• Embedding a proactive quality mindset by coaching teams on investigation best practices, promoting knowledge sharing, and ensuring lessons learned are institutionalized across the site.

Audits, Assessments & Walkthroughs

• Lead audits and walkthroughs to ensure compliance with cGMP, GDP, GEP, and safety systems.
• Identify gaps, drive corrective actions, and ensure regulatory alignment.
• Develop SMEs by coaching them.

EAMS (Enterprise Asset Management System)

• Define functional requirements and manage user setup, planning, and spare parts.
• Lead EAMS projects, reviews, and upgrades.
• Ensure data accuracy, monitor system performance, and resolve issues with vendors.

Maintenance Oversight

• Ensure timely completion of planned work orders.
• Monitor execution to identify and mitigate compliance risks.

Process Improvement & Projects

• Drive continuous improvement initiatives and oversee their implementation which improves quality excellence.

Reporting & Metrics

• Prepare and review MIS reports and compile site quality metrics.
• Trend failures/breakdowns and recommend corrective actions.

Culture & Compliance

• Act in line with Pfizer Values: Courage, Equity, Excellence, and Joy.
• Comply with statutory obligations and promote health, safety, and environmental standards.

Qualifications and competencies

• Technical graduate with 10+ years in the pharmaceutical industry.
• Strong knowledge of audits, compliance systems, and engineering processes.
• Develop and manage team performance through regular feedback and growth plans.
• Foster a culture of ownership, collaboration, and continuous improvement

PHYSICAL/MENTAL REQUIREMENTS

• Be highly organized as well as multitasker
• Be an effective communicator
• Stakeholder management
• Effective interpersonal skills
• Situational leadership and Conflict management.

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.
Quality Assurance and Control
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