Compliance Project Manager

Compliance Project Manager

Location: Geel

Working mode: On-site or Hybrid

Duration: Contract initially running until the end of 2025 (opportunity for a contract extension)

Hours: 40 hours (Employment Consultant/Temporary Worker) or 32 hours per week (Freelancer)

Pay rate range: Competitive hourly rate

Today, Janssen Belgium is an indispensable link in the worldwide production network of Johnson & Johnson. We make a distinction between the chemical production at our site in Geel and the pharmaceutical production at our sites in Beerse and Olen. The Janssen site in Geel is a high-tech chemical production site that is responsible for as much as 60% of the total production of active pharmaceutical ingredients (APIs) of the pharmaceutical companies of Johnson & Johnson.

At the moment, we are looking for Compliance Project Managers to join the team to support a system based compliance exercise and to lead compliance projects.

roles and responsibilities

Lead compliance projects in a multidisciplinary team setup under supervision of program manager.

• Strategic Planning: Develop and oversee the project plan, ensuring compliance aspects are integrated into the MES implementation strategy.

• Stakeholder Engagement: Collaborate with cross-functional teams, including, operations, quality assurance, and the MES core team, to ensure that all compliance requirements are understood and met.

• Risk Management: Identify, assess, and mitigate risks related to compliance and data integrity throughout the project lifecycle.

• Documentation Management: Ensure proper documentation of compliance processes, including the creation and maintenance of validation protocols, Standard Operating Procedures (SOPs), and change control documents.

• Training and Knowledge Transfer: Facilitate training programs for team members and end-users to ensure understanding of compliance requirements and system usage.

• Reporting and Feedback: Provide regular updates to senior management and other stakeholders on the status of compliance activities and any issues encountered.

how to succeed

Specific knowledge 

Required:

• Experience in Compliance: Demonstrated experience in managing compliance aspects related to manufacturing processes, in regulated industries such as pharmaceuticals.

• Project Management Skills: Strong project management skills, including proficiency in project planning, execution, and monitoring.

• Cross-Functional Collaboration: Proven ability to work collaboratively with multidisciplinary teams, 

Preferred:

• Knowledge of pharmaceutical manufacturing processes & products and/or equipment & facility engineering (if applicable) especially for the involved technology platform. 

• Knowledge of manufacturing site systems and procedures.

• Understanding of ICH, FDA, EMA… guidelines.

Personal and interpersonal skills / Leadership skills 

• Ability to work under pressure, handle conflicting interests, and take decisions.

• Strong analytical skills are a must

• Excellent verbal and written communication skills

• Ability to work independently under general direction, having a good sense of prioritization of assigned tasks goals and manage time accordingly.

• Customer and business focus.

• Problem solving skills and attitude.

• Hands-on, result oriented attitude.

• Facilitator in decision -making process with stakeholders.

Personal attitude and mindset 

• Motivated, self-starter able to work independently with demonstrated problem solving skills. Team player.

Good Manufacturing Practices (GxP)

• Adhere to applicable cGxP’s and procedures 

Safety, Health and Environment Performance

• Adhere to applicable EH&S and procedures (role model)

Degree

Bachelor or Master Degree in Science, Math, Engineering, Automation or other science related field

Languages

Required: Fluent in written and spoken English

benefits

This role offers a very competitive hourly rate. This contract will run for until the end of 2025 and has a strong chance of extension. 

you are welcome here

Johnson & Johnson Innovative Medicine/Janssen is working to create an inclusive environment where diverse backgrounds, perspectives, and experiences are valued and each and every one of our people feels that they belong and can reach their potential. No matter who they are.

about Johnson & Johnson Innovative Medicine

Patients inform and inspire our science-based innovations, which continue to change and save lives. Applying rigorous science and compassion, we confidently address some of the most complex diseases of our time and unlock the potential medicines of tomorrow.

Our diverse portfolio spans multiple therapeutic areas — Oncology, Immunology, Neuroscience, Cardiovascular, Pulmonary Hypertension, and Retina.

We are continuously working to develop treatments, aspiring to find cures, pioneering the path from lab to life, and championing patients every step of the way.

application process

We are looking to process the first round of applications within the next 2 working days.

We do not accept applications via email. The pay rate for this role will depend on how you are paid. Options are available. 

Diversity, Equity & Inclusion

For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo.

We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences. That is why we are working to create an inclusive environment where diverse backgrounds, perspectives and experiences are valued and each one of our people feels that they belong and can reach their potential. No matter who they are. Diversity, Equity & Inclusion at Johnson & Johnson means “You Belong”.