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Job Description:

Join Johnson & Johnson's R& D Quality Team!

Are you eager to learn, collaborate, and make a positive impact? As a Sr. Specialist in Process & Personnel Qualification Management, you will drive compliance and quality excellence in the pharmaceutical industry. In this role, you will lead process improvement projects and use the latest digital tools to support the transformation from traditional processes and training into a data centric content and qualification management system.

What You'll Do:

• You will lead process and training related projects, including process development, mapping, and training development/qualification and delivery.
• You will be a vital quality partner for PV/Medical Safety, promoting collaboration and serving as a link between business partners, quality groups, and governance. This role ensures that our GxP Quality Framework optimally adapts to both business and regulatory changes in a proactive manner.
• Your ability to manage tasks, timelines, and deliverables will be crucial for achieving successful project outcomes. Additionally, you will assist in addressing issues, managing risks, and providing timely updates to management and business owners regarding project progress.
• You will support the implementation of our digital transformation roadmap, driving our evolution towards data-centric content and a robust qualification management system.
• You may support additional projects, meetings, audits/inspections, etc. as directed.

Qualifications and Required Knowledge:

• Education: A Bachelor’s degree in Science or Business is required.
• Experience: A minimum of 3-5 years in a medium to large-scale matrix organization, with at least 3 years focused on pharmaceutical/device compliance. Preferred experience includes process design and training design.
• Interpersonal Skills: Outstanding proficiency in both oral and written English communication, with a talent for articulating complex ideas in a clear and effective manner.
• Regulatory Knowledge: Understanding of global (pre)clinical safety and pharmacovigilance compliance regulations and guidelines, coupled with experience in the life sciences industry's regulatory framework.
• Project Management Skills: Demonstrated expertise in leading intricate projects and encouraging collaboration among diverse teams and departments.
• Analytical Skills: Keen attention to detail and robust analytical thinking abilities to evaluate business processes and implement improvements.
• Leadership and Networking: Established track record in personal leadership, building relationships, working autonomously, and cultivating an inclusive work atmosphere that values diversity.