2 Investigation Management Jobs

The Engineering Compliance & Investigation Manager plays a crucial role in ensuring alignment with cGMP, cGEP, and regulatory standards in partnership with the Engineering Lead. Your responsibilities include leading internal audits, driving a quality culture, overseeing engineering quality metrics, and providing direction for maintenance processes using EAMS. It is essential to ensure compliance, training, and robust documentation, while demonstrating strong leadership in coaching, mentoring, and cross-functional collaboration to sustain and elevate engineering compliance. You will be responsible for compliance management, which involves ensuring adherence to quality systems, safety protocols, and regulatory guidelines. This includes reviewing and approving change controls, documents, and procedures, supporting root cause analysis, CAPA implementation, and timely closure of quality records, ensuring readiness for audits, and implementing Pfizer Quality Standards (PQS) while ensuring training completion. In terms of investigation management, you will lead structured investigations, equipment failures, and non-conformances, ensuring root cause identification and alignment with cGMP and regulatory expectations. This involves 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. You will also be monitoring and trending deviation data to identify systemic issues, recurring failure modes, and compliance risks, leveraging dashboards and quality metrics to prioritize focus areas and translating investigation insights into actionable improvement projects. Additionally, you will lead audits, assessments, and walkthroughs to ensure compliance with cGMP, GDP, GEP, and safety systems. This includes identifying gaps, driving corrective actions, ensuring regulatory alignment, and developing subject matter experts through coaching. Furthermore, you will define functional requirements and manage user setup, planning, spare parts, and lead EAMS projects, reviews, and upgrades. It is crucial to ensure data accuracy, monitor system performance, and resolve issues with vendors. Your role will also involve overseeing maintenance processes to ensure the timely completion of planned work orders and monitoring execution to identify and mitigate compliance risks. You will be expected to drive continuous improvement initiatives and oversee their implementation to improve quality excellence, prepare and review MIS reports, compile site quality metrics, trend failures/breakdowns, and recommend corrective actions. Upholding Pfizer Values and complying with statutory obligations while promoting health, safety, and environmental standards is also essential. As a qualified candidate, you should be a technical graduate with over 10 years of experience in the pharmaceutical industry, possessing strong knowledge of audits, compliance systems, and engineering processes. You should be capable of developing and managing team performance through regular feedback and growth plans while fostering a culture of ownership, collaboration, and continuous improvement. In this role, organizational skills, multitasking abilities, effective communication, stakeholder management, interpersonal skills, situational leadership, and conflict management are key requirements. The work location for this position is on-premise. Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.,

We are seeking a Senior Associate Quality Complaints professional to own and implement the end-to-end global complaint process and management system. This is a vital role that ensures our complaint processes and systems remain compliant with current internal and external requirements. The ideal candidate will be skilled in conducting low to medium complexity complaint investigations and will be a key player in translating market information to drive continuous improvement. Roles & Responsibilities Complaint Management: Evaluate and ensure triaged product complaint records align with applicable procedures. You will own complaint records with basic investigations and ensure their quality. Compliance & Documentation: Implement the complaint process per SOP requirements. You will own or manage the review/approval process flow of controlled documents in CDOCS , ensuring accuracy and consistency according to templates. Investigation & Analysis: Apply analytical skills to evaluate complex situations using multiple sources of information. You will also determine if investigations require further action. Project Support: Support the management of assigned projects or project tasks, including proactive communication, status updates, and tool maintenance, to achieve results within established timelines and quality standards. Technical Skills Experience in a quality and/or manufacturing role within the biotech, medical device, or pharmaceutical industry is preferred. Understanding of quality and industry requirements/expectations for a Quality Management System (QMS) . Understanding of applicable manufacturing/testing processes (e.g., API, Drug Substance, Drug Product, Packaging). Familiarity with basic project management tools. Qualifications A Master's degree with experience, a Bachelor's degree with relevant experience, or a Diploma with a substantial background in a science field or a related area of study. Soft Skills Problem-Solving: Strong analytical skills with the ability to evaluate complex situations and make data-driven decisions. Communication: Proven ability to communicate clearly and effectively, translating business and stakeholder feedback into accurate and efficient processes. Collaboration: The ability to operate in a matrixed or team environment, negotiating a position after taking feedback from multiple sources. Ownership: A demonstrated ability to lead functional teams, consistently deliver high-quality results, and manage your workload to meet timelines. Proactiveness: A high degree of initiative, with the ability to manage your workload effectively and proactively communicate with stakeholders.