Senior Csq Associate

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

This role is for a Senior CSQ Associate in the Clinical Supply Quality team at Johnson & Johnson. The primary focus is on reviewing and approving complaint investigations, ensuring scientific soundness and compliance. The role also involves contributing to complex investigations, process improvements, and acting as a Quality Lead for investigations related to Clinical Supply Planning and Logistics. While the role mentions an understanding of AI concepts and frameworks for efficiency, it is not core to the job function.

What you'd actually do

  1. In this role, you review and approve complaint records throughout the full investigation lifecycle. This includes confirming that investigations are complete, that root cause analyses are well supported, and that conclusions are based on clear evidence.
  2. You assess risks, review corrective and preventive actions, and check that the right stakeholders are involved. You also consider broader supply chain impacts to ensure decisions are consistent and practical.
  3. You contribute to improving how complaint processes work by identifying patterns, suggesting improvements, and supporting implementation. You also support escalation of critical issues by preparing clear, structured information for decision making.
  4. In addition, you act as Quality Lead for complex NC/CAPA investigations related to Clinical Supply Planning and Logistics. You collaborate with cross‑functional teams, support inspection readiness, and contribute to preparation for Health Authority inspections.
  5. As a subject matter expert, you represent the complaint process in projects and help strengthen quality practices across the organization. Building strong working relationships and sharing clear, practical feedback is an important part of this role.

Skills

Required

  • University degree in a scientific discipline (pharmaceutical, chemical, or biological sciences) or equivalent experience
  • Strong knowledge of investigations, complaint handling, and CAPA processes
  • Understanding of cGMP, Good Documentation Practices, and global regulatory expectations
  • Ability to review technical data (e.g., batch records, test results, protocols) and identify gaps or inconsistencies
  • Strong critical thinking and ability to assess whether conclusions are supported by evidence
  • Ability to evaluate risk and apply appropriate escalation
  • Clear communication skills, with the ability to provide structured and practical feedback
  • Strong organizational skills and ability to manage multiple priorities
  • Comfortable working independently and collaborating across teams
  • Demonstrates an understanding of AI concepts and frameworks, including awareness of responsible and ethical AI practices, and uses effective prompting techniques to support efficiency and productivity

Nice to have

  • Business Alignment
  • Business Savvy
  • Coaching
  • Communication
  • Compliance Management
  • Continuous Improvement
  • Fact-Based Decision Making
  • Human-Centered Design
  • ISO 9001
  • Issue Escalation
  • Problem Solving
  • Quality Control (QC)
  • Quality Management Systems (QMS)
  • Quality Standards
  • Regulatory Environment
  • Standard Operating Procedure (SOP)

What the JD emphasized

  • At least 5 years of experience in a regulated environment, including complaint or quality investigations
  • Demonstrates an understanding of AI concepts and frameworks, including awareness of responsible and ethical AI practices, and uses effective prompting techniques to support efficiency and productivity