Data-Driven Process & Qualification Lead

6010-Biosense Webster Inc. Legal Entity; High Wycombe; On-site; GBP 80,000 - 110,000; Full time

Job summary

Johnson & Johnson is seeking a Manager, Process & Personnel Qualification Management Expert to drive compliance and quality excellence within the pharmaceutical industry. You will lead pharmacovigilance processes, training development, and digital transformation initiatives to move toward a data-centric content and qualification management system.

The role requires strong project management, leadership, and communication skills, with experience in global regulatory frameworks and a matrix

Qualifications

• Education: At a minimum a Bachelor’s degree in Science or Business is required (Masters degree is preferred).
• Experience: A minimum of 5 years in a medium to large-scale matrix organization, with at least 5 years focused on pharmaceutical/device compliance.
• Regulatory Knowledge: Understanding of global (pre)clinical safety and pharmacovigilance compliance regulations.
• Project Management: Demonstrated expertise in managing intricate projects and fostering collaboration among diverse teams.

Responsibilities

• Lead PV process and training related projects, including process development, mapping and training development/qualification and delivery.
• Act as quality partner for IM OCMO, promoting collaboration and linking business partners, quality groups and governance.
• Ensure GxP Quality Framework adapts to regulatory changes and business needs.
• Manage tasks, timelines and deliverables, address issues and risks, and provide updates to management.

Skills

BPM

BRD analysis

Coaching

Compliance management

Cross-functional collaboration

Fact-based decision making

ISO 9001

Process governance

Process improvements

Quality validation

Stakeholder engagement

SOP

Tactical thinking

Education

Bachelor’s degree in Science or Business

Master’s degree (preferred)

Job description

Johnson & Johnson is seeking a Manager, Process & Personnel Qualification Management Expert to drive compliance and quality excellence within the pharmaceutical industry. You will lead pharmacovigilance processes, training development, and digital transformation initiatives to move toward a data-centric content and qualification management system.

The role requires strong project management, leadership, and communication skills, with experience in global regulatory frameworks and a matrix