Johnson & Johnson Careers
BioResearch QA Auditor Senior Specialist
Requisition ID: 1805637814W
- Independently leads the planning, conduct and reporting of BioResearch QA routine and non-routine audits of activities, data, internal facilities and processes in GxP/non-regulated to assure adherence to corporate policies, internal standards/requirements and compliance with applicable regulatory requirements. Non-routine audits include Due Diligence for cause audits, cross-functional, complex/sensitive system/service provider audits as defined by the scope. May support other auditors in planning, conduct and reporting of audits.
- Ensures the relevant standard procedures, diagnostic tools, and audit plans are fully understood and applied in audit activities.
2. Inspection Support
Participates in regulatory inspections in core and supporting roles
3. Training & Development
- Assists in preparation and delivery of training materials, as well as advises and contributes to mentoring.
- Completes training requirements in a timely manner to ensure inspection readiness at all times.
4. People Management
5. Project Management
- Takes an active role in projects as assigned by supervisor and interacts with key partners as appropriate.
- Meets priorities, checkpoints and timelines for all aspects of work and projects to achieve adequate progress.
6. Subject Matter Expert / Point of Contact
Provides expertise and knowledge to less experienced auditors, business partners, and the core business sector on quality and compliance processes/procedures. Interprets and applies regulations/policies to issues of moderate complexity, when required.
A Bachelor of Science (BSc) or Arts (BA) degree or the equivalent in training and experience is required. Preferably 5 years in an R&D environment.
- Comprehensive knowledge of the drug development process, applicable regulations (GxP), R&D practices, and scientific and quality terminology.
- Expertise in pharmacovigilance with one or more specific compliance disciplines (non-regulated, GLP, GCP, GDP, GMP or computerized systems) preferred.
- Knowledge of procedural and records management requirements in a regulated industry preferred.
- Prior pharmaceutical and quality/compliance related experience preferred.
- Possess excellent communication skills in written and spoken English
- Able to work well within a team
- With keen attention to detail and good organisational skills
- Sound problem solver with good negotiating skills
- Proficiency in Microsoft Office applications
- Possess quality mindset
- Willing to do overnight travel, nationally and internationally, of up to 40%
J&J (China) Investments Ltd A- Beijing Branch (7075)