Johnson & Johnson Careers
QUALITY & COMPLIANCE MANAGER
Requisition ID: 1905753407W
At Janssen, we are dedicated to addressing and solving some of the most important unmet medical needs of our time in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. Driven by our commitment to patients, we bring innovative products, services and solutions to people throughout the world. Janssen is a pharmaceutical company of Johnson & Johnson. Please visit www.janssen.com for more information.
Location: Warsaw, Poland
Global Clinical Operations (GCO) Poland is specialized in conducting clinical trials to evaluate the efficacy and safety on new therapeutic solutions within Janssen.
Quality & Compliance Manager is accountable for comprehensive quality and compliance oversight within GCO department in accordance with relevant SOPs (Standard operating procedures), policies and regulatory requirements.
- Shape quality and compliance driven environment
- Develop and manage local quality processes and procedural documents
- Support onboarding of new hires
- Diagnose and address training needs with the department
- Provide guidance regarding SOPs and GCP
- Coordinate / perform quality checks and remediation actions
- Monitor quality and compliance metrics, audit findings and issues
- Support local and central business partners in inspections, office and site audits, including CAPA setting and implementation
- Perform impact assessments of new/revised local regulations, guidance and standards
- Coordinate or support special investigation and issue remediation activities
- Conduct local vendor assessments, including certification and training, if required
- Shaping effective collaboration with local supporting functions (i.e. Business Support), central functions (i.e. BRQC) and Local Operating Company (i.e. Business Quality, Pharmacovigilance, Legal and HCC)
We would love to hear from YOU, if you have:
- Experience in management of clinical trials (min. 8 years)
- Experience in quality oversight in clinical trials (site audits, inspections)
- Sound understanding of ICH/GCP and local regulatory requirements
- Ability to work under time pressure and prioritize accordingly
- Strong focus on process improvements and problem solving
- Ability to negotiate over conflicting issues and develop win-win outcomes
- Ability to independently plan, organize, coordinate, manage and execute assigned tasks
- Excellent communication, networking and interpersonal skills
- Proficiency in spoken and written English and Polish
- 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 employees benefits.
Janssen-Cilag Polska Sp. z o.o. (7824)