Johnson & Johnson Careers
BRQC – QA GCP Auditor (Specialist) ( 1 of 2)
Titusville, New Jersey; France; United Kingdom; California, United States; Raritan, New Jersey; Spring House, Pennsylvania; Netherlands; Switzerland; Belgium; Germany; Spain
Requisition ID: 00001EUY
Janssen Research & Development, LLC discovers and develops innovative medical solutions to address important unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. Please visit http://www.JanssenRnD.com for more information. The preferred location is Titusville, NJ however Raritan, NJ, Springhouse, PA, California or Europe is also acceptable.
• Leads the planning, conduct and reporting of BioResearch GCP QA routine audits and supports non-routine GCP audits including Clinical Investigator Site audits, Trial/Program audits, External Service Provider audits, Process/System audits, Local Operating Country audits, 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.
• Ensures the relevant standard procedures, audit tools, and audit plans are fully understood and applied in audit activities.
• Analyzes, interprets data and identifies patterns and trends in data sets.
• Ensures timely and appropriate review & delivery of CAPAs and actions arising from audits.
• Presents information logically and concisely, both verbally and in writing, including writing reports with clarity
• Provides GCP Audit strategy support, especially on QA risk-based auditing approach (Audit plans)
• Supports regulatory inspections in various supporting roles.
Training & Development
• Completes assigned training requirements in a timely manner to ensure inspection readiness at all times.
• May assist in the preparation of training material if requested
• Participates in projects or serves on teams, as assigned by supervisor.
• Meets priorities, checkpoints and timelines for all aspects of work and projects to achieve adequate progress.
• Bachelor's degree required; Advanced degree in scientific, medical or related discipline preferred.
• Minimum of 3 years of experience working in Clinical Quality & Compliance, Clinical Operations, and/or related R&D area is required.
• Knowledge of the drug development process, applicable regulations, R&D practices, and scientific and quality terminology is required.
• Computer literacy & Analytics - Experience using standard applications/systems & data analytics tools is required
• Familiarity with new and emerging technologies and analytics, and ability to identify opportunities where creative capabilities may be applied within QA audit processes is preferred
• Experience conducting Clinical Quality Assurance audits is preferred.
• Knowledge of Good Clinical Practices (GCP) and applicable regulations/guidelines (e.g. FDA regulations, ICH E6 R2 is required.
• Ability to interpret global regulatory standards is preferred.
• Understanding of fundamentals of clinical trial risk management is required.
• Broad knowledge of management of standard operating procedures, good documentation practices, and records management is required.
• Inspection support experience (FDA, EMA and other inspectorates) is preferred
• Conflict management/negotiation skills is preferred.
• Strong networking and relationship building skills is preferred.
• Ability to plan and organize work in an efficient manner and work well under time constraints is required.
• Flexibility to respond to changing business needs is required.
• Experience managing multiple projects simultaneously is preferred.
• Travel Up to 30% required (national and international).
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
United States-New Jersey-Titusville-
Europe/Middle East/Africa-France, Europe/Middle East/Africa-United Kingdom, North America-United States-California, North America-United States-New Jersey-Raritan, North America-United States-Pennsylvania-Spring House, Europe/Middle East/Africa-Netherlands, Europe/Middle East/Africa-Switzerland, Europe/Middle East/Africa-Belgium, Europe/Middle East/Africa-Germany, Europe/Middle East/Africa-Spain
Janssen Research & Development, LLC. (6084)