Manager, GD Quality Management

Johnson Johnson; High Wycombe; On-site; GBP 85,000 - 115,000; Full time

Job summary

Johnson & Johnson in Buckinghamshire (High Wycombe) seeks a Manager in Process & Personnel Qualification Management to drive compliance and quality excellence in pharma. You will lead process and training initiatives, develop mappings, and deliver qualification programs.

You will partner with Global Development, manage schedules and risks, and contribute to the digital transformation of qualification management using data-centric approaches.

Qualifications

• Bachelor’s degree in Science or Business required; Master’s preferred.
• Minimum 5 years in a medium/large matrix organization, 5 years in pharma/device compliance.
• Fluent English, strong written and oral communication.
• Knowledge of global (pre)clinical safety and pharmacovigilance regulations.
• Proven project management skills in cross-functional settings.
• Strong analytical and process-improvement capabilities.
• Proven leadership, networking, and autonomous working style.

Responsibilities

• Lead process and training projects including process development, mapping, and training delivery.
• Act as quality partner for Global Development, linking business, quality, governance.
• Manage tasks, timelines, deliverables; report progress and risks to management.
• Support digital transformation roadmap toward data-centric content and qualification management.
• Lead additional projects, audits/inspections as needed.

Skills

Leadership

Project management

Analytical thinking

Communication (English)

Regulatory compliance

Stakeholder engagement

Process improvement

Education

Bachelor''s degree in Science or Business

Master''s degree preferred

Job description

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions 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 jnj.com .

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function:

Quality

Job Sub Function:

Business Process Quality

Job Category:

Professional

All Job Posting Locations:

High Wycombe, Buckinghamshire, United Kingdom

Job Description:

Manager, Process & Personnel Qualification Management Expert Join Johnson & Johnson's R&D Quality 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. 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 Global Development, 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, 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 or lead additional projects, meetings, audits/inspections, etc. as directed.

Qualifications and Required Knowledge:

• 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.

Preferred Skills:

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