LEO Pharma | Quality Assurance Senior Specialist | ...

Location: Madison 07601, New Jersey, United States Contract type: Permanent Job ID: 2768 Role Description Quality Assurance Senior Specialist, North America The Senior Quality Assurance Specialist will support the implementations of the Quality Management Systems at LEO Pharma and maintain it to assure Compliance. The Quality Assurance Specialist will receive, process, and close out cases for the Product Quality Complaints received for LEO product and ensure they are handled appropriately to sustain compliance with company standards SOPs and regulatory requirements. This individual will oversee and support the activities for the Veeva Vault - Electronic Document Management System to stay current with individuals' training status, update Master list of documents, keep track of individuals' training requirements in the system for newly hired positions and ensure compliance with their training requirements. The Quality Assurance Senior Specialist will assist the Senior Quality Director in implementation of new Standard operating procedures, work instructions/processes, maintenance of implemented LEO Quality Management systems to sustain green level compliance, perform Self Inspections of company's internal departments, and provide assistance during the audits from Health Authorities. This role will report directly to the Senior Director, Quality Americas The position is also accountable for supporting business users on all functional matters relating to Veeva Vault including maintenance of document metadata. Your role • Assist/maintain a current list of all QMS activities that includes Deviation, CAPAs etc. • Assist in generating the Audit Plan, schedules, CAPAs, and follow-up activities. • Monitor and process incoming calls through Quality line, collect complaint/inquiry information from customers, document details in Veeva Vault complaints module (Global Complaint intake system) and ensure that the received complaints are processed according to the established procedure. • Ensure accurate, organized and up-to-date records of complaints are maintained. • Ensure timely complaint notifications are sent to third party vendors according to the existing procedures. • Prepare and disseminate Monthly reports for Quality Complaints. • Stay current in maintaining the Master list of documents. Ensure that new documents are added and the obsoleted documents are marked for the Veeva Vault system (QMS requirement). • Collaborate closely with People and Communications (HR) to maintain training matrix for new and current employees. Your qualifications: • 2-3 years of experience in Quality and/or Quality Assurance function in the pharmaceutical industry with minimum 2 years at Quality Coordinator or similar level. • Knowledge on Quality Management Systems in Pharmaceutical industry is preferred; experience with Veeva Vault highly desired. • Bachelor's Degree required in field of Science. • Bilingual in French preferred. • Certified Quality Auditor preferred. • Strong collaborative and influencing skills, and ability to work well in a cross-functional, matrixed environment. • Analytical and problem-solving skills. • Excellent written and oral communication and interpersonal skills. • Highly organized and ability to manage multiple priorities. • Ability to work independently and with various work groups. • Strong attention to detail and excellent organization. • Experience with "Health Authorities" inspections preferred. Your application You do not need to upload a cover letter, but feel free to add a few sentences in your resume or CV on why this position has your interest. Beyond the skin Join LEO Pharma, a global leader in medical dermatology, as we go beyond the skin to make a lasting impact. Our innovative approach sets us apart. We are dedicated to leaving a legacy that positively impacts patients, colleagues, and our planet. At LEO Pharma, we believe in the power of individuals to drive change. Our flat organizational structure empowers you to make a visible impact and offers versatile roles for professional growth. We value diversity and welcome applications from all qualified candidates, recognizing that our different perspectives, backgrounds, and attitudes enable us to make the best decisions. Join our passionate team at LEO Pharma and be yourself as we work together to make a difference. For certain positions, LEO Pharma might complete a background check conducted by a third party. Join us on our journey Beyond the Skin. Apply today! #LI-Hybrid

Created: 2024-12-09