QMS Deviation Specialist

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:

Quality

Job Sub Function:

Quality Systems

Job Category:

Professional

All Job Posting Locations:

Beerse, Antwerp, Belgium

Job Description:

About Innovative Medicine

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

Learn more at https://www.jnj.com/innovative-medicine

 

Johnson and Johnson Innovative Medicines is recruiting for QMS Deviation Specialist to be based at the Beerse, Belgium site.

 

The role of the QMS Deviation Specialist

In the IMSC Beerse & Olen Quality Systems team we are currently looking for a QMS Deviation Specialist. The QMS Deviation Specialist has responsibility and oversight of the NC/CAPA process and related records and activities stemming from this. The position will work in partnership with and support the entire IMSC Beerse & Olen organization, the Site and Quality Leadership team, and liaise closely to and influence the global oragaisation.

The position will be the NC/CAPA Business Process Owner (BPO) for the site. The position will work effectively to facilitate deployment of NC/CAPA training, changes and guidance. This includes tracking NC/CAPA KPI performance, facilitating actions to address risks, and ensuring compliance with the process throughout the site.

 

 The responsibilities and the impact YOU will have: 

• Act as the IMSC Beerse & Olen Business Process Owner for the NC/CAPA process. Effectively collaborate with the global NC/CAPA and other QMS teams as appropriate to assure alignment and compliance with global regulations.
• Provide leadership on the NC/CAPA process through partnerships/collaboration with SMEs, Record Owners and Quality Leaders and key stakeholders, to oversee execution of program management activities for compliance improvements, and if necessary, remediation programs.
• Use site data (e.g., audits, inspections, QMS trends, etc.) to identify needs and facilitate the implementation of compliant solutions where appropriate.
• Establish, monitor and report on key performance measures to ensure compliance is on track.
• Perform gap assessments in their area as needed and required.
• Collect and review relevant metrics regarding the NC/CAPA process and act as appropriate.
• Ensure inspection readiness across the site for the NC/CAPA process.

  

We would love to hear from YOU, if you have the following essential requirements:

• University degree, preferably with a scientific orientation, or equal by experience.
• Minimum of 5 years of experience in a Quality oriented role within a Pharmaceutical, Medical Device and/or OTC Drug Industry environment is preferred.
• Must have excellent written and oral communication skills in English and in Dutch.
• Experience in pharmaceutical supply chain and/or Quality Assurance is an asset.
• Knowledge of GMP, Quality Management Systems and Operational Quality is an asset.
• Inspection and spokesperson experience is an asset.
• Demonstrated ability to work independently while staying connected with key stakeholders.
• Ability to prioritize, perform risk assessment and develop action plans.
• Understands the business implications regarding quality positions and decisions.

 

 Required Skills and Abilities:

• Strong interpersonal skills, including ability to communicate with individuals and groups at all levels. Experience establishing relationships with other functions within the company.
• Strong decision making and analysis skills.
• Demonstrated conflict and change management skills.
• Strategic Thinking – ability to view bigger picture and translate complex issues into solution based answers that drive real and sustainable change.
• Sense of Urgency - ability to lead and deliver on multiple projects in a timely manner.
• Confidentiality – ability to maintain confidentiality as appropriate.
• Adjustment – self-confidence and self-control in high pressure environments, effective stress management.
• Demonstrates an understanding of AI concepts and frameworks, including awareness of responsible and ethical AI practices, and has experience generating effective prompts to boost efficiency and productivity.

 

 

Are you ready to make an impact?

 

If you want to leave your personal mark and be valued for who you are, Johnson & Johnson offers an unusual experience to professionals looking for an opportunity to work with hardworking people who share your real passion for caring in an environment that empowers you to drive your own career and that you feel you can bring your whole self to work.

We provide you an environment to fulfil your career aspirations as well as promoting your physical and mental wellbeing. You will receive a competitive compensation and benefits package as well as benefits that can be tailored to what is valuable to you throughout different stages of your life.

Johnson & Johnson Innovative Medicine

Explore how Johnson & Johnson Innovative Medicine applies rigorous science and patient-centered innovation to transform healthcare—with breakthrough treatments in oncology, immunology, neuroscience.

#SCQuality

 

 

Required Skills:

 

 

Preferred Skills:

Agility Jumps, Analytical Reasoning, Analytics Dashboards, Coaching, Collaborating, Communication, Compliance Management, Data Compilation, Data Quality, Data Savvy, Document Management, Problem Solving, Quality Auditing, Quality Control (QC), Quality Management Systems (QMS), Quality Services, Quality Standards, System Audits, Systems Analysis

  

 

The anticipated base pay range for this position is:

€72,500.00 - €115,230.00

 

 

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.