Senior Compliance Analyst
Senior Compliance Analyst
Locations: Beerse, Belgium
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Requisition ID: 1905744947W
Janssen Research & Development, L.L.C., a division of Johnson & Johnson's Family of Companies is recruiting for a Senior Compliance Analyst located in Beerse, Belgium.
At the Janssen Pharmaceutical Companies of Johnson & Johnson, what matters most is helping people live full and healthy lives. We focus on treating, curing and preventing some of the most devastating and complex diseases of our time. And we pursue the most promising science, wherever it might be found.
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.
We are Janssen. Our mission drives us. Our patients inspire us. We collaborate with the world for the health of everyone in it.
Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.
* Provide guidance and Support to laboratory staff on GxP study data and supporting data.
* Work to ensure quality and compliance with the Biologics Development Sciences department.
* Lead teams to execute process improvements in compliance.
* Work cross-functionally with business partners to align and standardize best compliance practices.
* Provide independent regulatory guidance to laboratory staff.
* Perform process and data review supporting non-clinical and clinical analysis in the GLP and GCP environment in the BDS department
* Work cross-functionally to align GxP practices with other Janssen business partners.
* Collect user requirements and voice of customer input to deliver training solutions for new technology and processes.
* Maintain the highest level of GxP compliance and evaluate department policies for efficiencies.
* Ensure quality of and compliance to SOPs.
* Assist in execution of business process inspections.
* Organize and execute internal compliance monitoring and business assessment of outsourced vendors in alignment with BDS SOMT.
* Contribute to Regulatory submissions.
* Guide the work of project members to accomplish team objectives on time and within budget.
* Lead the development of departmental SOPs and process improvements.
BS in Biological Sciences or Communications required. A Master's degree or other advanced degree with a minimum of 3 years relevant pharmaceutical/scientific experience; or a Bachelor's degree with a minimum of 5 years of relevant pharmaceutical/scientific experience.
Experience and Skills:
* Strong oral and written communication skills.
* Attention to detail.
* Ability to function and potentially lead in a matrixed global team environment.
* Organizes time well.
* Demonstrates learning agility.
* Builds solid and positive relationships with cross-functional team members.
* Strong leadership skills (influencing, negotiating, assertiveness, taking initiative).
* Strong expertise in areas of GLP/GCP compliance is required.
* Familiarity with CAP/CLIA requirements.
Janssen Research & Development, LLC. (6084)