Qms Deviation Specialist

Johnson & Johnson Johnson & Johnson · Pharma · Beerse, Antwerp, Belgium

Johnson & Johnson is seeking a QMS Deviation Specialist in Beerse, Belgium. This role is responsible for the Non-Conformance/Corrective and Preventive Action (NC/CAPA) process, acting as the Business Process Owner. The specialist will collaborate with global teams, provide training, monitor KPIs, identify compliance needs through data analysis, and ensure inspection readiness. The role requires strong communication skills in English and Dutch, experience in a pharmaceutical quality role, and knowledge of GMP and Quality Management Systems. While the role is primarily focused on quality systems, it also mentions an understanding of AI concepts and prompt generation for efficiency.

What you'd actually do

  1. 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.
  2. 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.
  3. Use site data (e.g., audits, inspections, QMS trends, etc.) to identify needs and facilitate the implementation of compliant solutions where appropriate.
  4. Establish, monitor and report on key performance measures to ensure compliance is on track.
  5. Perform gap assessments in their area as needed and required.

Skills

Required

  • University degree, preferably with a scientific orientation, or equal by experience.
  • Excellent written and oral communication skills in English and in Dutch.
  • Ability to prioritize, perform risk assessment and develop action plans.
  • Strong interpersonal skills, including ability to communicate with individuals and groups at all levels.
  • Strong decision making and analysis skills.
  • Demonstrated conflict and change management skills.
  • Strategic Thinking
  • Sense of Urgency
  • Confidentiality
  • Adjustment

Nice to have

  • 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.
  • 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.

What the JD emphasized

  • Must have excellent written and oral communication skills in English and in Dutch.