Manager, GD (Global Development) Quality Management

7555-Janssen Pharmaceutica NV Legal Entity; Geel; Sur place; EUR 80 000 - 138 000; Plein temps

Avantages offerts par ce poste

Annual bonus

Vacation days

Parental leave

Bereavement leave

Caregiver leave

Well-being reimbursements

Insurance plans

Résumé du poste

Johnson & Johnson in Belgium is seeking a Manager, Process & Personnel Qualification Management Expert to lead process improvement and qualification management within the R&D Quality Team. You will drive compliance, partner with Global Development, and guide digital transformation toward a data-centric system.

The role requires a Bachelor’s degree in Science or Business, 5+ years in a large matrix, and strong English communication, with expertise in BPM, SOP, and quality governance.

Qualifications

• Education: Bachelor’s degree in Science or Business; Master’s degree preferred.
• Experience: 5+ years in a medium to large-scale matrix organization with at least 5 years in pharmaceutical/device compliance.
• Communication: Exceptional English communication, both oral and written.
• Regulatory Knowledge: Familiar with global (pre)clinical safety and pharmacovigilance regulations and life sciences regulatory framework.
• Project Management: Proven ability to manage complex projects with cross-functional teams.
• Analytical Skills: Strong attention to detail and analytical thinking.

Responsabilités

• Lead process and training related projects, including process development, mapping, and training/qualification delivery.
• Act as a quality partner for Global Development, fostering collaboration between business partners, quality groups, and governance.
• Ensure GxP Quality Framework adapts to regulatory changes in a proactive manner.
• Manage tasks, timelines, and deliverables to achieve project outcomes.
• Support implementation of the digital transformation roadmap toward data-centric content and qualification management.
• May support or lead additional projects, audits/inspections as directed.

Connaissances

BPM

Business Requirements Analysis

Coaching

Compliance Management

Cross-Functional Collaboration

Data Savvy

Fact-Base Decision Making

ISO 9001

Leverages Information

Process Governance

Process Improvements

Process Optimization

Quality Control

Quality Standards

Quality Validation

Stakeholder Engagement

Standard Operating Procedure

Tactical Thinking

Technical Credibility

Formation

Bachelor’s degree in Science or Business

Master’s degree (preferred)

Description du poste

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. 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: Allschwil, Basel-Country, Switzerland, Beerse, Antwerp, Belgium, Breda, Netherlands, High Wycombe, Buckinghamshire, United Kingdom, Horsham, Pennsylvania, United States of America, Titusville, New Jersey, United States of America

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.

Required Skills: Preferred Skills:

• Business Process Management (BPM)
• Business Requirements Analysis
• Coaching
• Compliance Management
• Cross-Functional Collaboration
• Data Savvy
• Fact-Base 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

The anticipated base pay range for this position is:

€79’800.00 - €137’770.00

Benefits:

• an annual bonus with set target (% of pay) depending on pay grade / location, where the actual amount is based on the employees’ and companies’ performance of the previous calendar year, or sales commissions.
• Moreover, we offer vacation days, parental leave for a minimum of 12 weeks, bereavement leave, caregiver leave, volunteer leave, well-being reimbursement, programs for financial, physical and mental health.
• We also offer service anniversary and recognition awards, and subject to the terms of their respective plans, employees - and in some location’s eligible dependents - can participate in several insurance plans.
• For more information, visit Employee benefits | Supporting well-being & career growth | Johnson & Johnson Careers.
• *This is for informative purposes only. Amounts and actual benefits may vary by location and are subject to change.

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 https://www.jnj.com/.