Manager, GD Quality Management (Open)

6084-Janssen Research & Development, LLC Legal Entity; Horsham (PA); On-site; USD 117,000 - 201,000; Full time

Job summary

Johnson & Johnson's R&D Quality Team seeks a Manager in Process & Personnel Qualification Management to drive compliance and quality excellence in the pharmaceutical industry. You will lead process improvement projects and support the transformation toward a data-centric content and qualification management system.

You will collaborate with Global Development, manage timelines and deliverables, address issues and risks, and communicate progress to stakeholders.

Qualifications

• Education: Bachelor’s degree in Science or Business is required, Masters preferred.
• Experience: 5+ years in a large matrix organization with pharmaceutical/device compliance.
• Communication Skills: Excellent English communication, both oral and written.
• Regulatory Knowledge: Familiar with global (pre)clinical safety and pharmacovigilance regulations.
• Project Management: Ability to manage complex projects and cross-functional teams.
• Analytical Skills: Strong attention to detail and data-driven thinking.
• Leadership and Networking: Proven leadership, collaboration, and inclusive work style.

Responsibilities

• Lead process and training projects including development, mapping, and delivery of training/qualification.
• Serve as a quality partner for Global Development, coordinating with business partners, quality groups, and governance.
• Ensure GxP Quality Framework adapts to regulatory and business changes.
• Manage tasks, timelines, and deliverables to achieve project outcomes.
• Address issues, manage risks, and provide updates to management and owners.
• Support the digital transformation roadmap toward data-centric content and qualification management.
• May support or lead additional projects, audits/inspections as directed.

Job description

Manager, Process & Personnel Qualification Management

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

Job Function: Quality

Job Sub Function: Business Process Quality

Job Category: Professional

All Job Posting Locations: Horsham, Pennsylvania, United States of America, Titusville, New Jersey, United States of America

Job Description

Manager, Process & Personnel Qualification Management 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.

Required 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

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

Pay

The anticipated base pay range for this position is : $117’000.00 - $201’250.00

Additional Description for Pay Transparency

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 https://www.jnj.com/.