Manager, GD Quality Management

jj; High Wycombe; On-site; GBP 90,000 - 130,000; Full time

Job summary

Johnson & Johnson in the United Kingdom seeks a Manager, Process & Personnel Qualification Management Expert to drive compliance and quality excellence in the pharmaceutical industry. You will lead process improvement projects and support the transformation to a data-centric qualification management system.

This role collaborates with Global Development, ensures GxP alignment, manages timelines and risks, and champions digital tools as part of a broader transformation.

Qualifications

• Bachelor’s degree in Science or Business; master’s preferred.
• Minimum 5 years in a medium to large-scale matrix organization with at least 5 years focused on pharmaceutical/device compliance.
• Excellent written and spoken English.
• Knowledge of global regulatory requirements and pharmacovigilance in life sciences.
• Strong project management with cross-functional collaboration.
• Analytical thinking and attention to detail.
• Leadership and networking with a track record of autonomous work.

Responsibilities

• Lead process and training projects including development, mapping, and qualification delivery.
• Act as a quality partner for Global Development and coordinate with partners, quality groups, and governance.
• Manage timelines, deliverables, risks, and provide progress updates to stakeholders.
• Support the digital transformation roadmap toward data-centric content and qualification management.

Skills

Process Management

Quality Assurance

Regulatory Knowledge

Project Management

Leadership

Communication

Analytical Skills

Data Analytics

GxP Compliance

Education

Bachelor's degree

Masters preferred

Job description

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 jnj.com.

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