Manager, GD Quality Management

Johnson and Johnson; Zug; Vor Ort; CHF 120.000 - 160.000; Vollzeit

Zusammenfassung

Johnson & Johnson Zug, Switzerland, seeks a Manager in Process & Personnel Qualification Management to drive compliance and quality excellence within the pharmaceutical development pathway. You will lead process development, mapping, and training qualification and delivery, and partner with Global Development and governance.

You will address regulatory changes, manage complex projects, and support a data-centric qualification management system across teams, contributing to our digital

Qualifikationen

• Bachelor's degree in Science or Business is required.
• Minimum 5 years in a medium to large-scale matrix organization with at least 5 years focused on pharmaceutical/device compliance.
• Excellent proficiency in English (spoken and written).
• Regulatory knowledge of global (pre)clinical safety and pharmacovigilance, with life sciences regulatory exposure.

Aufgaben

• Lead process development, mapping, and training qualification and delivery.
• Serve as a quality partner for Global Development and governance across functions.
• Ensure GxP Quality Framework adapts to business and regulatory changes proactively.
• Manage tasks, timelines, risks, and deliverables and update management accordingly.

Kenntnisse

Process management

Project management

Leadership

Communication

Quality compliance

BPM

Cross-functional

Data analytics

Ausbildung

Bachelor's degree in Science or Business

Master's degree preferred

Jobbeschreibung

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:QualityJob Sub Function:Business Process QualityJob Category:ProfessionalAll Job Posting Locations:Zug, Switzerland

Job Description:

Manager, Process & Personnel Qualification Management ExpertJoin 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.

• 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: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