Job Opportunities API

Your Profile: • Bachelor's degree in Life Sciences, a Scientific Discipline, Project Management, Business Management, or a related field. Candidates with alternative educational backgrounds and significant relevant experience will also be considered. • Minimum of 2 years' experience in a pharmaceutical industry GxP-regulated role. • Strong knowledge of quality systems, compliance processes, and pharmaceutical industry regulations, including ICH guidelines and industry standards. • Demonstrated ability to work independently, take ownership of assigned projects, and deliver results with minimal supervision. • Excellent interpersonal skills with the ability to build effective cross-functional relationships and work successfully within global teams. • Strong organizational, communication, influencing, and stakeholder management skills. • Ability to identify process improvement opportunities and implement practical, innovative solutions. • Working knowledge of CAPA development and quality system methodologies is preferred. • Experience supporting or implementing electronic quality systems and digital quality tools is advantageous. • Strong computer skills, including Microsoft Office applications. Experience with SAP, Veeva, TrackWise, SharePoint, collaboration tools, or quality databases is desirable. • Excellent written and verbal communication skills in English. • Limited travel may be required. Your Tasks: • Establish and maintain processes for reporting Quality KPIs across global affiliates. • Coordinate inspection readiness activities throughout the global affiliate network. • Support quality management system compliance activities, ensuring policies, SOPs, work instructions, and related documentation remain current, effective, and aligned with business and regulatory requirements. • Manage the integration of Affiliate Quality SOPs with Global CSL procedures and facilitate procedure updates to incorporate affiliate and local requirements. • Provide quality support to US Commercial Operations as required. • Support Product Technical Complaint (PTC) activities for the US market. • Support Global Change Control, Deviation, and CAPA processes across assigned regions. • Support and perform product release activities for the US market and Kankakee-manufactured export products, collaborating with manufacturing site representatives as needed. • Lead and/or support implementation of global electronic quality systems such as SAP, Master Data Governance, and DocNet. • Ensure effective communication with internal and external stakeholders regarding progress, improvements, risks, and compliance-related matters.