Business quality specialist
Location: Serbia, Belgrade
Contract: Maternity cover
Responsible for Medical Devices Vigilance in Serbia, leading the local Quality organization, supporting other SEE countries under the same QMS, and regional Quality organization to ensure implementation, maintenance and upgrading of the local Quality System and SOPs to drive compliance of all GXP related processes.
The responsibilities & the impact YOU will have:
- Lead local Quality organization and support regional organization to ensure implementation, maintenance and upgrading of the local Quality System and SOPs to drive compliance of all GXP related processes;
- Responsible person for Medical Devices Vigilance ensuring local organization’s compliance;
- Ensure efficient information flow and effective communication of all relevant Quality and Regulatory (when required) matters within the Serbian affiliate;
- 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 Quality and local affiliate. Assure that gaps are addressed appropriately and escalate critical trends to Management Team and Global Quality;
- 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 (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;
- Travel across SEE and CEE region when required.
We would love to hear from YOU, if you have:
- Previous Quality experience is essential. Regulatory experience is preferred;
- Degree in university school of medicine, dentistry, pharmacy, technology, electrical engineering, mechanical engineering, chemistry, or other appropriate
- Preferred experience in Quality Role within a Medical Device or other GMP controlled environment;
- Knowledge of Serbian legislation regarding Medical Devices Vigilance;
- Preferred experience as responsible person for Medical Devices Vigilance, and training in the field of vigilance;
- Knowledge regarding quality standard ISO 9001 requirements;
- Preferred experience as lead auditor (ISO 9001, internal audits, supplier, and distributor audits);
- Experience in NC, CAPA, change management;
- Strong collaboration and influencing skills and ability to build partnerships internally and externally;
- Excellent written and oral English communication skills;
- Advanced knowledge of MS.
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.
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”!
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