Commercial Quality (Senior) Specialist

Commercial Quality (Senior) Specialist Location: Bucharest, Romania Contract: full time Responsible for Medical Device Vigilance in Romania and supporting other CEE South Region (SEE) countries as required, lead the local QA organization and support regional organization to ensure implementation, maintenance and upgrading of the Quality System and SOPs in order to drive compliance of all GXP related processes and support CEE South Region (SEE) region (CEE and EMEA region as required). The responsibilities & the impact YOU will have: Lead the local QA organization and support regional organization to ensure implementation, maintenance and upgrading of the Quality System and SOPs in order to drive compliance of all GXP related processes. Responsible person for Medical Device vigilance ensuring local organization compliance Ensure efficient information flow and effective communication of all relevant quality and regulatory (when required) matters within the Romanian affiliate (supporting CEE South Region (SEE) region as required). Having overview of local and international regulatory and legislative requirements and communicate them to local/regional and to Global Quality Assurance when required. Ensure an adequate process is in place to report and monitor the predefined KPI's, in alignment with Global QA and local affiliate. Assure that gaps are addressed appropriately and escalate critical trends to Management Team and Global QA. Provide quality oversight and direction to local third parties and ensure that they are qualified to perform their activities. Ensure readiness of local affiliate for all GxP regulatory inspections. Ensure management of external inspections, complaints, deviations, recalls, counterfeits and product tampering. Ensure that local and/or regional (CEE South Region (SEE), CEE) audits and self-inspections are performed within the organization and at 3rd parties, as appropriate. Ensure that any deficiencies identified through audits or other means are addressed. Ensure that within the local affiliate a GxP training program is established, and training timely performed, documented and its effectiveness checked. Sample warehouse responsible for Romania. Qualifications We would love to hear from YOU, if you have: Bachelors or Masters degree in university school of medicine, dentistry, pharmacy, technology, electrical engineering, mechanical engineering, chemistry, business. Previous experience in Quality is essential. Regulatory experiences are preferred and considered as advantage. Experiences as responsible person for Medical Devices Vigilance and training in the field of vigilance of medical devices are preferred. It is preferred that this experience includes 3+ years in Quality Role within a Medical Device or other GMP controlled environment. Knowledge of Romanian legislations regarding Medical Devices vigilance. Knowledge of other regulation regarding Medical Devices is advantage. Experience with quality standard ISO 9001:2015 or ISO 13485:2016. Experienced certified lead auditor (ISO 9001:2015, supplier audits, internal audits) Experience in Quality Issue Management (Nonconformance and CAPA management) Change management experience and influencing and interpersonal skills Strong collaboration skills and ability to build partnerships internally and externally English - fluent Romanian - fluent Advanced knowledge of Excel, PowerPoint, Word This is what awaits YOU at J&J: An opportunity to be part of a global market leader. A dynamic and inspiring working environment. Many opportunities to work on challenging projects and assignments. Possibilities for further personal as well as professional development. Many employee benefits. Employee benefits are regulated by an internal policy that contains full details regarding the entitlement and conditions for the benefits. For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo. We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences That is why we in Johnson & Johnson are working to create an inclusive environment where diverse backgrounds, perspectives and experiences are valued and each and every one of our people feels that they belong and can reach their potential. No matter who they are. Diversity, Equity & Inclusion at Johnson & Johnson means “You Belong”! Primary Location Romania-Bucuresti-Bucharest- Organization JOHNSON & JOHNSON ROMANIA S.R.L. (7159) Job Function Quality Requisition ID 2206055137W