Sr. Specialist, Process & Personnel Qualification Management

Johnson & Johnson Innovative Medicine; High Wycombe; On-site; GBP 60,000 - 70,000; Full time

Job summary

Join a leading company as a Sr. Specialist in Process & Personnel Qualification Management where you will drive compliance and quality excellence in R&D. You will support training development and manage collaboration between diverse teams and business partners to ensure regulatory compliance and process improvement.

Qualifications

• A minimum of 3-5 years in a medium to large-scale matrix organization.
• Experience focused on pharmaceutical/device compliance.
• Exceptional proficiency in oral and written English communication.

Responsibilities

• Support business process and training-related projects.
• Manage tasks, timelines, and deliverables for project outcomes.
• Assist in implementing a digital transformation roadmap.

Skills

Communication Skills

Analytical Skills

Leadership

Education

Bachelor’s degree in Science or Business

Job description

Sr. Specialist, Process & Personnel Qualification Management

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Sr. Specialist, Process & Personnel Qualification Management

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At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions are personal.Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.Learn more at https://www.jnj.com

Job Function

Quality

Job Sub Function

Business Process Quality

Job Category

Professional

All Job Posting Locations:

Allschwil, Basel-Country, Switzerland, Beerse, Antwerp, Belgium, Breda, Netherlands, High Wycombe, Buckinghamshire, United Kingdom, Horsham, Pennsylvania, United States of America, Raritan, New Jersey, United States of America, Titusville, New Jersey, United States of America

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 R&D. In this role, you will support business process management projects and use the latest digital tools to support the transformation from traditional process development and training into a data centric content and qualification management system.

What You'll Do

• You will support business process and training related projects, including process development, process mapping, and training development/qualification and delivery.
• You will be a vital quality partner for PV/OCMO/Medical Safety, promoting collaboration and serving as a link between business partners, quality groups, and governance. This role ensures that our GxP Quality Framework effectively 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.
• Communication Skills: Exceptional 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 managing intricate projects and fostering 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.

Seniority level

• Seniority level

  Not Applicable

Employment type

• Employment type

  Full-time

Job function

• Job function

  Management and Manufacturing

• Industries

  Pharmaceutical Manufacturing

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