Manager, GD Quality Management

Johnson & Johnson Innovative Medicine; Zug; Vor Ort; CHF 150.000 - 190.000; Vollzeit

Zusammenfassung

Johnson & Johnson Innovative Medicine in Zug seeks a Manager, Process & Personnel Qualification Management to drive compliance and quality excellence in the pharmaceutical field. You will lead process improvement projects and enable a data-centric qualification management system.

Collaborating with Global Development, quality groups, and governance, you will manage timelines, risks, and deliverables while supporting the digital transformation roadmap.

Qualifikationen

• 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.
• Communication Skills: Exceptional proficiency in both oral and written English communication.
• Regulatory Knowledge: Understanding of global (pre)clinical safety and pharmacovigilance compliance regulations.
• Project Management Skills: Demonstrated expertise in managing intricate projects and fostering collaboration.
• Analytical Skills: Robust analytical thinking to evaluate processes and improvements.
• Leadership and Networking: Track record in leadership, building relationships, autonomous work, and diversity.

Aufgaben

• Lead process and training related projects, including process development, mapping, and training development/qualification and delivery.
• Serve as a quality partner for Global Development, promoting collaboration and linking business partners, quality groups, and governance.
• Manage tasks, timelines, and deliverables, address issues, manage risks, and update management on progress.
• Support the implementation of the digital transformation roadmap toward data-centric content and qualification management.
• May lead or support audits/inspections and additional projects as directed.

Kenntnisse

Process Management

Project Management

Quality Assurance

Data Literacy

Leadership

Cross-functional Collaboration

Regulatory Knowledge

Communication Skills

Analytical Thinking

Stakeholder Engagement

Ausbildung

Bachelor's degree in Science or Business

Master's degree

Jobbeschreibung

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:

Zug, Switzerland

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