Manager, Process & Personnel Qualification Management Expert

Johnson & Johnson Co.; Geel; In loco; EUR 81.000 - 141.000; Tempo pieno

Vantaggi offerti da questo lavoro

Annual bonus program

Flexible vacation policy

Well-being programs

Descrizione del lavoro

Johnson & Johnson in Beerse/Antwerp is hiring a Manager, Process & Personnel Qualification Management Expert. Lead PV processes and training initiatives, driving compliance and quality in the pharma space.

You will guide transformation toward data-centric qualification management and partner with Global Quality teams to deliver governance and process improvements. The role emphasizes project leadership, collaboration, and effective communication across diverse functions, ensuring timely delivery

Competenze

• Bachelor’s degree in Science or Business required; Master’s preferred.
• Minimum 5 years in a large matrix organ with pharma/device compliance.
• Strong English communication, both oral and written.
• Knowledge of global regulatory standards and pharmacovigilance.

Mansioni

• Lead PV process and training projects, including process development and training delivery.
• Drive compliance and quality excellence in pharma; partner with IM OCMO.
• Manage projects, timelines, risks, and communications to stakeholders.
• Support digital transformation toward data-centric qualification management.

Conoscenze

Quality management

Process governance

BPM

Regulatory compliance

Project management

Cross-functional collaboration

Analytical thinking

Leadership

Stakeholder engagement

Coaching

Formazione

Bachelor’s degree in Science or Business

Descrizione del lavoro

About Johnson & Johnson

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

Job Posting Locations

Beerse, Antwerp, Belgium

Job Description

We are searching for the best talent for a Manager, Process & Personnel Qualification Management Expert. Join Johnson & Johnson's Process & Data Management 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.

Purpose: 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. You will be responsible for:

You will lead Pharmacovigilance (PV) process and training related projects, including process development, mapping, and training development/qualification and delivery.

You will be a vital quality partner for Innovative Medicines Office of the Chief Medical Officer (IM OCMO), 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, manage risks, and provide 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 / Requirements

• 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
• Fact-Based Decision MakingISO 9001
• Process Governance
• Process Improvements
• Process Optimization
• Quality Control (QC)
• Quality Standards
• Quality Validation
• Stakeholder Engagement
• Standard Operating Procedure (SOP)
• Tactical Thinking

Preferred Skills

• Business Process Management (BPM)
• Business Requirements Analysis
• Coaching
• Compliance Management
• Cross-Functional Collaboration
• Fact-Based Decision Making
• ISO 9001
• Process Governance
• Process Improvements
• Process Optimization
• Quality Control (QC)
• Quality Standards
• Quality Validation
• Stakeholder Engagement
• Standard Operating Procedure (SOP)
• Tactical Thinking

Salary

The anticipated base pay range for this position is: €81,400.00 - €140,530.00

Benefits

• In addition to base pay, we offer the following 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.

Company Culture

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/. Our Credo calls on us to respect the dignity of every individual and create an environment for all people to thrive.

Throughout the recruitment process - from application through hiring - we are committed to providing reasonable accommodations/adjustments for qualified candidates with disabilities.