Manager, Process & Personnel Qualification Management Expert

Biopharma Asia; Antwerpen; Hybrid; EUR 81,000 - 141,000; Full time

Benefits offered by this job

Annual bonus

Vacation days

Parental leave

Bereavement leave

Well-being reimbursement

Service anniversary / recognition

Job summary

Johnson & Johnson is seeking a Manager, Process & Personnel Qualification Management to lead PV process and training projects, driving compliance and quality in the pharmaceutical industry.

You will collaborate with the Innovative Medicines Office of the Chief Medical Officer and cross-functional teams, managing timelines, risks, and deliverables while supporting a digital transformation toward data-centric qualification management.

Qualifications

• Bachelor’s degree in Science or Business required, Master’s preferred.
• Minimum 5 years in a medium/large matrix organization with at least 5 years in pharmaceutical/device compliance.
• Strong English communication, both oral and written.
• Knowledge of global (pre)clinical safety and pharmacovigilance compliance regulations.
• Proven project management skills and ability to lead complex, cross-functional initiatives.
• Analytical mindset with attention to detail and ability to drive improvements.
• Demonstrated leadership, networking, and collaboration across teams.

Responsibilities

• Lead PV process and training projects, including process development, mapping, training development/qualification and delivery.
• Partner with IM OCMO and governance groups to ensure GxP Quality Framework adapts to changes.
• Manage tasks, timelines and deliverables; address issues and risks; provide updates to management.
• Support digital transformation roadmap toward data-centric content and robust qualification management.
• Lead or support audits, inspections, and other related activities as directed.

Skills

Business Process Management

Business Requirements Analysis

Coaching

Compliance Management

Cross-Functional Collaboration

Fact-Based Decision Making

ISO 9001

Process Governance

Process Improvements

Process Optimization

Quality Control

Quality Standards

Quality Validation

Stakeholder Engagement

SOP

Tactical Thinking

Education

Bachelor’s degree in Science or Business

Job description

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.

Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s):

Belgium R-109382, Switzerland R-109383, United Kingdom R-109384, United States of America R-107418

Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.

Job Function:

Quality

Job Sub Function:

Business Process Quality

Job Category:

Professional

All 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:

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

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.