QMS Deviation Specialist

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at .

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

As a QMS Deviation Specialist you will:

In the IMSC Beerse & Olen Quality Systems team we are currently looking for a Senior QA Associate Quality Systems. The Senior QA Associate Quality Systems 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 IMSC Beerse & Olen Quality Leadership team the QA/QS team and the IMSC organisation.

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.
• 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:

• Excellent written and oral communication skills.
• 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.

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.

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