Senior Associate, Quality Systems Risk Management

Job Title

CSQ Senior Associate, Quality Systems – Risk Management

Job Location(s)

Beerse, Antwerp, Belgium and Latina, Italy (Requisition Number: R- ). Switzerland (R- ). The Netherlands (R- ).

Job Description Summary

Enforces quality requirements, establishes quality systems for new technologies, reviews development data, approves master clinical production records and executed records, sets inventory status, delivers training on standard operating procedures, approves investigations and supports activities related to regulatory submissions and inspections.

Role Purpose

The CSQ Senior Associate, Quality Systems – Risk Management is a key contributor to the Clinical Supply Quality organization, responsible for coordinating and overseeing quality systems with a strong focus on risk management, governance, and quality oversight in support of clinical trial supplies.

The role ensures compliance with GMP, quality, regulatory, and internal compliance requirements and partners closely with cross‑functional stakeholders to maintain inspection readiness and drive continuous improvement.

Key Responsibilities

• Prepare for and participate in quality governance and oversight meetings (e.g., QOR, GGB, QSMR) as assigned.
• Collect, monitor, analyze, and present key quality metrics and risk‑based indicators in accordance with established procedures.
• Leverage digital and AI‑enabled tools, where approved, to support:
  • Trend analysis and metrics evaluation
  • Risk identification and data review
  • Drafting and reviewing quality documentation (with appropriate QA oversight)
• Develop and maintain trend analyses (e.g., monthly/quarterly trend reports) to identify systemic risks and improvement opportunities.
• Provide insights and recommendations to Quality Systems management to support risk‑based decision‑making.
• Attend and/or lead operational oversight meetings (e.g., NC and Change Control focus teams).
• Ensure consistent application and integration of quality systems across clinical supply activities.
• When needed, provide hands‑on support across other Quality CoEs, including NC/CAPA, Change Control, Training & Documentation, Inspections & Audits processes.

Required Qualifications

• Bachelor’s degree in Life Sciences or a related field.
• Minimum 5 years of experience in an FDA and/or EMA regulated pharmaceutical, biotech, or clinical manufacturing environment (R&D experience is an asset).
• Strong working knowledge of:
  • GMP and quality systems
  • Risk management, deviation, CAPA, and change control processes
  • Quality governance and metrics trending
• Familiarity working with digital and AI‑enabled tools to support data analysis, documentation, and quality system activities, with a clear understanding of validation, compliance, and data integrity expectations.
• Ability to operate effectively with minimal supervision and manage multiple priorities.
• Proven capability to lead complex quality issues and drive resolution across stakeholders.
• Fluent knowledge of English language.

Preferred Qualifications & Skills

• Familiarity with quality systems such as COMET, SUMMIT, TruVault, VMP and other analytical tools.
• Experience working in data‑driven or digitally enabled quality environments.
• Strong analytical, problem‑solving, and communication skills.
• Ability to work effectively in a matrix, cross‑functional, and global environment.

Why Join CSQ

• Be part of a high‑impact clinical supply quality organization.
• Contribute to risk‑based quality governance supporting early‑ and late‑phase clinical development.
• Gain exposure to multiple Quality Centers of Excellence and global quality systems.
• Work in a collaborative environment focused on quality excellence and continuous improvement.

Additional Skills

• Project Quality.
• Quality Services, Quality Standards.