Leadership Role: Quality and Compliance Oversight
Main Responsibilities:
* Ensure quality compliance for manufacturing, quality systems, quality control, validation, facilities, and materials management in accordance with regulatory requirements and site expectations.
* Oversee site quality systems, including deviations, CAPA, change control, audits, and customer complaints.
* Review and approve documents related to area functions, such as failure investigations, change control documents, corrective/preventative action documents, and standard operating procedures.
* Approve procedures, policies, and instructional documents to ensure compliance with company policy and regulatory requirements.
* Monitor and trend metrics for site quality systems.
* Manage and develop site risk assessment activities and risk register.
* Participate in continuous improvement initiatives.
* Participate in regulatory and customer audits.
* Collaborate with functional departments to resolve issues and maintain compliance.
* Identify gaps in systems and develop plans for correction.
* Train personnel on quality system processes.
Requirements:
* BSc/BEng in a scientific discipline or related field.
* 7+ years of relevant work experience in the pharmaceutical or related industry.