Who is Janssen? We’re more than 30,000 people working hard to prevent, treat, cure and stop some of the most devastating and complex diseases of our time. From heart disease to HIV, Alzheimer’s disease to cancer, we are committed to issues that touch everyone’s lives. Our mission is to transform individual lives and fundamentally change the way diseases are managed, interpreted, and prevented. We believe that challenging something is the best way to change it. So every day, in more than 150 countries, we bring cutting-edge science and the most creative minds in the industry together to think differently about diseases. We aim not only to innovate but also to empower people with the tools they need to make informed decisions and achieve the best possible results for their health.
The NCC Compliance Specialist is responsible for performing activities within the assigned country/countries that (1) ensure an integrated and comprehensive quality and compliance approach for clinical trials in close collaboration with local and global quality and compliance functions, and (2) ensure clinical trials are performed in compliance with local laws and regulations, industry standards and Johnson & Johnson / Janssen global processes and procedures.
Quality Oversight Activities
Monitor compliance risk and ensure mitigation/remediation actions are defined
Monitor progress and confirm effectiveness of remediation plans, e.g. by performing QC checks or special investigations and plan, prepare, conduct and report QC checks and compliance assessments to ensure risk signals are addressed in a timely manner. More specifically perform the following risk-based activities:
Perform assigned reviews of Trial Master File, training compliance documentation and other checks per QP&S Integrated Quality Plan for the trial
Planning and execution of local QC checks
Support and advise local study teams in root cause analysis of significant observations
Ensure appropriate filing of the QC reports
Support Quarterly Quality Reviews with local GCO management addressing compliance issues and risk signals
Collaborate with local and central business partners to facilitate (local) inspections and office audits as needed
Collaborate with local and central business partners in timely CAPA setting and implementation. Provide Quality Event Management (QEM) CAPA Champion support. Moderate level of risk awareness and ability to translate risks into actions.
Support the local impact assessment of global procedural documents and if applicable support development and management of associated local procedural documents
Local Onboarding and Consultation
Support onboarding of new hires
Manage local workshops to support QMS and compliance awareness, Lessons Learned, etc
Provide advice regarding SOP, system and GCP questions of moderate complexity
Support managing risk at the country level, including assessing root causes and developing effective actions to mitigate risk
Local regulatory intelligence
Perform impact assessments of new/revised local regulations, guidance and standards
Support central functions in ensuring local intelligence is up to date
Collaboration with Business Quality
Support LOC Management Review in collaboration with LOC Business Quality partners
Support local vendor assessments as appropriate
Support annual Due Diligence update, certification and training of local vendors, if applicable
The NCC Compliance Specialist has a dual reporting line into the Director of the Non-Core Country Global Oversight Office and the NCC Compliance Leader, and is a member of the NCC Compliance Team and <regional> Compliance Team.
Education and Experience Requirements:
A minimum of a Bachelor Degree in Science (BSc) or Arts (BA) or 4-6 years relevant experience equivalent is required. A minimum of 3 years of previous Pharmaceutical Industry experience is required, with at least 2 years of GxP experience within clinical research and development and/or quality assurance.
Knowledge of the overall drug development process
Developing or developed skills and knowledge of business processes and practices (i.e., SOPs governing clinical research activities)
Experience in quality assurance activities, including audits of clinical investigative sites, systems and vendors, and audits of regulatory submissions is an asset
Ability to translate data into information and strategies into executable action plans improving the business
Ability to motivate professional colleagues and stakeholders
Conflict resolution/management and negotiation skills
Ability to independently plan, organize, coordinate, manage and execute assigned tasks
Experience of the key customers’ business processes and practices
Good working knowledge of FDA/ICH and country-specific regulations and guidelines related to clinical development;
Experience with regulatory submissions (NDA, BLA) is an asset
Highly committed to quality
Flexible and persistent
Good conflict handling/negotiation skills
Able to create win-win situations with internal and external partners
Knowledge of the corporate structure and culture
Impact - Complexity and Scope - Contributes to the definition and development of new processes, standards or operational plans in support of the organizational/ business strategies, with a direct impact on business unit/function overall results.
Typically has responsibility for smaller scope projects.
Manages limited number of projects, including some of moderate complexity. Leads smaller scope projects.
Contributes to local and regional strategy
Nature of Communication - Influences or persuades others within area of immediate responsibility, scope and level to accept new ideas, approaches and concepts.
Identifies issues; exercises judgment in developing new approaches/solutions and resolving issues within immediate area of responsibility and scope.
Other Skills and Abilities:
Requires limited supervision. Possess good written, oral communication, interpersonal skills, diplomacy, and presentation skills and customer service.
Excellent knowledge of English is required
Proficient in Microsoft Office applications
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.
Netherlands-South Holland-Leiden- Other Locations
Europe/Middle East/Africa-Belgium-Antwerp-Beerse, Europe/Middle East/Africa-United Kingdom-England-High Wycombe Organization
Janssen Biologics (7266) Job Function
R&D Requisition ID
Open Positions from Johnson & Johnson Family of Companies