Johnson & Johnson Careers

Quality Assurance Leader

Warsaw, Poland
Validation


Job Description

Requisition ID: 1805700292W

The Medical Devices segment produces a broad range of innovative products used primarily by health care professionals in the fields of orthopaedics, neurovascular, surgery, vision care, diabetes care, infection prevention, cardiovascular disease, sports medicine, and aesthetics. This segment is comprised of our Global Medical Solutions, Global Orthopaedics and Global Surgery Groups.

 
Quality Assurance Leader
Location: Warsaw, Poland
Contract: Permanent
Ref no. 1805700292W
 

We are looking for a Quality Assurance Leader who will be part of Quality team in cross-sector Distribution Center in Poland within CEE region of Deliver organization. Distribution Center is responsible for distribution of medicinal products/medical devices. Other processes within Distributions Center: repack-relabel of products, decontamination of Instruments sets. The role may have specific country responsibilities within processes for products distributed in Poland and e.g. Baltics.

 
Main responsibilities:
  • Support compliance to all applicable quality standards & regulatory requirements, attending the timely and effective deployment of J&J Standards requirement
  • Supervise GxP Documentation: updating, distribution, archiving and accepting/approval process including gap assessment and  implementation of corporate quality standards or law requirements
  • Activities in scope of Quality Management System including corrective and preventive actions (CAPA) process, deviations, complaints, document management, change control, training management, validation/qualification, quality planning and quality KPI reporting and other quality processes based on Quality Management System requirements
  • Improvement of Quality System in line with J&J/MD strategies & initiatives
  • Perform quality investigation, root cause analysis, define and track corrective & preventive actions and mitigation/remediation plans for deviations & internal /external audits (notified Bodies, Health Authorities etc.), JJRC audits
  • Attend an Audit Program playing role of auditor or auditee for an assigned area
  • Attend Field Actions and Complaints management and coordinating with Customer Service, Business Quality J&J Franchise requirements (as applicable)
  • Participation in activities in scope of supplier qualification program including establishing Quality Agreements with suppliers
  • Support Training program with respect to Quality System elements, including training to organization on Quality relevant topics
  • Attend Quality processes within Quality Management according to principles in the country’s organization & drive continuous improvement
  • Coordinate quality project according to quality goals with performance monitoring and effective communication within organization
  • Demonstrate Leadership behaviors expected by J&J Credo and Leadership Principals
  • Maintain current knowledge of regulatory changes through industry publications, seminars, trainings
  • Additional travel within EMEA may be required occasionally.


Qualifications
Qualifications:
  • Bachelors or Master’s degree in Bioscience, Engineering or Business or equivalent field coupled with relevant business experience in Quality leadership roles
  • 3+ years working experience in function with assigned responsibility in quality/regulatory area
  • Experienced in Internal/external audits
  • Track record of leading projects
  • Change management experience and influencing and interpersonal skills
  • Experience working in a global or regional context would be desired
  • Strong collaboration skills and ability to build partnerships internally and externally
  • Advanced level in written and oral English communication skills are required
  • Ability to effectively present information to internal/external partners including Management level
  • High Quality System knowledge and understanding of Regulatory Compliance requirements for relevant market, business partnership meaning within organization
We Offer:
  • 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
 


Primary Location
Poland-Mazowieckie-Warsaw-
Organization
Johnson & Johnson (Poland) Sp. z.o.o. (7815)
Job Function
Validation
Requisition ID
1805700292W