Quality & Qualification Process Lead (Pharma)

Biopharma Asia; High Wycombe; Hybrid; GBP 90,000 - 120,000; Full time

Job summary

Johnson & Johnson in High Wycombe, UK seeks a Manager, Process & Personnel Qualification Management Expert to drive compliance and quality excellence in the pharmaceutical field.

You will lead process improvements, qualification management, and training initiatives, partnering with IM OCMO and governance bodies to ensure the GxP framework adapts to changes in business and regulation, delivering timely project outcomes.

Qualifications

• Strong English communication, both written and verbal.
• Proven ability to manage complex projects with cross-functional teams.
• Analytical thinking and attention to detail in process evaluation.
• Proven leadership, relationship-building, and inclusive teamwork.
• Knowledge of global regulatory requirements in life sciences and pharmacovigilance.

Responsibilities

• Lead PV process and training projects, including development, mapping, and delivery of training/qualification.
• Serve as quality partner for IM Office of the Chief Medical Officer (IM OCMO), connecting business partners with governance and quality groups.
• Manage tasks, timelines and deliverables; identify risks and provide updates to management and stakeholders.
• Support implementation of the digital transformation roadmap toward data-centric content and qualification management.
• May lead or participate in additional projects, audits/inspections, and related activities as needed.

Skills

Communication Skills

Project Management

Analytical Skills

Leadership & Networking

Regulatory Knowledge

Education

Bachelor’s degree in Science or Business

Job description

Johnson & Johnson in High Wycombe, UK seeks a Manager, Process & Personnel Qualification Management Expert to drive compliance and quality excellence in the pharmaceutical field.

You will lead process improvements, qualification management, and training initiatives, partnering with IM OCMO and governance bodies to ensure the GxP framework adapts to changes in business and regulation, delivering timely project outcomes.