Commercial Quality Specialist - 2406188795W

Description

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/

Within J&J MedTech, we are recruiting a Commercial Quality Specialist to be based in Belgrade (Serbia).

Overall purpose of job

Responsible for Medical Device Vigilance in Serbia, lead the local QA organization and support the regional organization, to ensure implementation, maintenance and upgrading of the local Quality Management System and Standard Operating Procedures to drive compliance of all GXP related processes and support CEE South region (CEESAT region as required)

Essential duties and responsibilities:

• Lead the local QA 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 Device vigilance ensuring local organization compliance

• Ensure efficient information flow and effective communication of all relevant quality and regulatory (when required) matters within the Serbian affiliate

• Having an overview of local and international regulatory and legislative requirements and communicating them to local/regional and 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 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

Other features of the job:

• Travel across CEE South and CEESAT region when required

Job location:

• Serbia. Travel to other CEE South countries under the same QMS and CEESAT countries (if required)

Qualifications

• Bachelor's or Master's degree in medicine, dentistry, pharmacy, technology, electrical engineering, mechanical engineering, or chemistry

Essential knowledge and skills:

• Previous experience in Quality is essential. Regulatory experience is an advantage

• Experience as a responsible person for Medical Devices Vigilance is preferred

• Preferred experience includes 3 years in a Quality role within a Medical Device or GMP-controlled environment

• Knowledge of Serbian legislation regarding Medical Devices Vigilance is required. Knowledge of other relevant regulations is an advantage

• Experience with the quality standard ISO 9001 is necessary

• Certified lead auditor with experience in ISO 9001, supplier audits, and internal audits

• Experience in Nonconformance, CAPA, and Change Management

• Strong collaboration skills and the ability to build partnerships both internally and externally

• Excellent written and oral English communication skills and local language

Johnson & Johnson is an equal opportunity employer, all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.

Primary Location Europe/Middle East/Africa-Serbia-Central Serbia-Belgrade

Organization Johnson & Johnson S.E., Inc. Slovenia (7395)

Job Function Customer/Commercial Quality

Req ID: 2406188795W