Manager, Process & Personnel Qualification Management Expert

On-site in High Wycombe·Full-time·Added 2 days ago (last checked 6 Nov)

Johnson & Johnson

55 open roles

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Our summary

Work mode: On-site, High Wycombe
Contract: Full-time
Experience: 5+ years

Skills

Nice to have

Requirements

Nice to have

Business Process Management (BPM), Business Requirements Analysis, Coaching, Compliance Management, Cross-Functional Collaboration, Fact-Based Decision Making, ISO 9001, Process Governance, Process Improvements, Process Optimization, Quality Control (QC), Quality Standards, Quality Validation, Stakeholder Engagement, Standard Operating Procedure (SOP), Tactical Thinking

Education & certifications

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. 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.

The role

What you'll do

You will lead Pharmacovigilance (PV) process and training related projects, including process development, mapping, and training development/qualification and delivery.
You will be a vital quality partner for Innovative Medicines Office of the Chief Medical Officer (IM OCMO), 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 address issues, manage risks, and provide 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 or lead additional projects, meetings, audits/inspections, etc. as directed.

Job Description

Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s):

Belgium R-109382, Switzerland R-109383, United Kingdom R-109384, United States of America R-107418

Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.

Job Function: Quality

Job Sub Function: Business Process Quality

Job Category: Professional

All Job Posting Locations: High Wycombe, Buckinghamshire, United Kingdom

We are searching for the best talent for a Manager, Process & Personnel Qualification Management Expert.

Join Johnson & Johnson's Process & Data Management Team!

Are you eager to learn, collaborate, and make a positive impact? As a Manager in Process & Personnel Qualification Management, you will drive compliance and quality excellence in the pharmaceutical industry.

Purpose: 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.

Hiring process

2 steps3 interviews

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Digital interview
Video call · 30–60 min
Either pre-recorded answers to sent questions (about 10 minutes, you can re-record twice) or a live video interview of 30 minutes to an hour.
Interviews with the team
With hiring manager, sometimes other team members · 1–2 sessions
Questions about your academic and work experience, with time for your own questions.
Offer

Reviewing applications for popular roles can take several weeks.
Interviewers are trained in fair hiring and ask behavioural, competency-based questions.