Johnson & Johnson Careers
Manager, Bioresearch Quality and Compliance
Requisition ID: 1905742054W
The purpose of this position is to provide quality and compliance expertise, oversight and performance of related duties and responsibilities. As a subject matter expert, the position will provide leadership, facilitation and support related to quality and compliance for CSS clinical and pre-clinical studies, audits, and inspections.
Under general direction of the Director, BRQC (CSS) and in accordance with all applicable national, federal, state and local directives/laws/regulations and Corporate Johnson & Johnson, procedures, guidelines, and standards, the Manager, Bioresearch Quality and Compliance (BRQC) will:
• Provide Quality Assurance (QA) oversight of Clinical and Pre-Clinical Programs.
• Serve as a subject matter expert for Good Clinical Practice (GCP) and Good Laboratory Practice (GLP), Data Protection, EU Medical Device Regulations, ISO 14155, and, in general, serve as the GCP/GLP Subject Matter Expert for Clinical/Pre-Clinical R&D Project Teams.
• Conducts audits and assessments of clinical investigational sites, external service providers such as clinical research organizations, ethics committees, institutional review boards (as appropriate), and pre-clinical sites, including ensuring the effectiveness of their Quality Assurance Unit.
• Conducts internal audits of Clinical/Pre-Clinical R&D, including study documentation, e.g. Clinical Study Reports, Trial Master Files.
• Support Health Authority and J&J Regulatory Compliance Inspections; partner with CSS Q&C and Johnson & Johnson Regulatory Compliance organizations to manage and support external inspection and ensure inspection readiness for bioresearch programs.
• Collaborate with Clinical/Pre-Clinical R&D to ensure that investigational sites, CROs and internal organizations are ready for third party inspections.
• Report to and work in close collaboration with the Director, BRQC CSS to develop and implement effective GCP and GLP quality programs across the CSS Franchise.
- Be responsible for communicating business related issues or opportunities to next management level
o For those who supervise or manage a staff, be responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable
o Be responsible for ensuring personal and Company compliance with all national, federal, state, local directives, regulations, guidelines, and standards, and company policies, procedures, and standards.
EXPERIENCE AND EDUCATION
A minimum of a Bachelor’s degree is required
A minimum of 6 years of business experience is required
- A thorough understanding and experience with the application of Good Clinical Practice (GCP) is required.
- Experience working in the Medical Device or Pharmaceutical industry is required.
- Experience working in a R&D/Clinical Trials/Clinical QA environment is highly preferred.
- Previous experience with quality control or quality assurance activities is required.
- Broad based technical knowledge and skills in diverse areas of business (ex: R&D, Operations, QA, laboratories, etc.) is preferred.
- Ability to effectively negotiate with andinfluence project teams is preferred.
- Strong verbal and written communication skills are required
The primary location of the position is in Diegem, Belgium and may be, performed remotely, with approval of supervisor.
This position may require up to 25% travel (domestic and international).
Johnson & Johnson Medical NV (7546)