Global Regulatory, RWE & Medical (2RM) Quality Operations Manager

As a Global Regulatory, RWE & Medical (2RM) Quality Operations Manager at Opella, your role involves supporting the Global Regulatory, RWE, and Medical teams by implementing and maintaining Quality Systems to ensure that activities are conducted and data are generated, documented, and reported in compliance with GxP requirements. Key Responsibilities: - Event & CAPA: - Perform QA assessment, root cause analysis, and investigation report - Review and approve closure of CAPA - Ensure timely closure of investigations and CAPAs - Escalate risks to 2RM Lead and manager as required - Change control: - Create Change Control as per 2RM Quality Lead assessment - Coordinate until Change Control closure for timely closure - Audit & inspection operations: - Run risk tool - Contribute to Global/Local audit & inspection preparedness - Monitor and support CAPA closure - Vendors quality management: - Perform qualification and maintain the list of preferred vendors - Excluding G2 market - Performance management: - Report KPIs and escalate issues with remediation plan - Quality document & training: - Implement QD & Training management in 2RM under Global QD & Training head guidance - Perform Gap assessment and maintain Quality documentation - Update and assign local & global training curricula - Manage CMS & LMS access - Report QD & training KPI In addition to the above responsibilities, you will also: - Provide Quality System expertise and support to Global Regulatory, RWE, and Medical teams - Support Connect access management for the teams - Elevate Quality Culture within the organization Qualifications Required: - Experience: 5-10 years in Quality systems - Soft skills: client orientation, outcome obsessed, assertiveness, networking capability, collaborative & team worker - Technical skills: quality systems Regulatory, RWE, and Medical - Education: Graduate in Chemistry, Biochemistry, Pharmacy, Engineering (related fields) - Languages: English is compulsory (working language) As part of Opella's team, you will have the opportunity to work on challenging and purposeful tasks, contribute to the development of consumer brands, and be part of a collaborative and inclusive culture where you can thrive and grow. Join us on our mission to bring health into people's hands at Opella.,