Senior Associate, Quality Systems Risk Management

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 .

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.

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Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings we recommend focusing on the specific country(s) that align with your preferred location(s):

• Italy and Belgium- Requisition Number: R-071431
• Switzerland - Requisition Number: R-071435
• The Netherlands - Requisition Number: R-071388

J&J IM is recruiting for a CSQ Senior Associate Quality Systems Risk Management reporting to the Sr Manager Clinical Supply Quality and to be based in one of the locations where the role has been posted.

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.

Job Description

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 crossfunctional stakeholders to maintain inspection readiness and drive continuous improvement.
When required the role provides operational and subjectmatter support to other Quality Centers of Excellence (CoE) including NC/CAPA Change Control Documentation & Training and Audits.

Key Responsibilities

Quality Governance & Risk Management

• • 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 riskbased indicators in accordance with established procedures.

  • Leverage digital and AIenabled 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 riskbased decisionmaking.

Operational Quality Oversight

• • 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.

Support to Quality Centers of Excellence (CoE)

When needed provide handson support across other Quality CoEs including NC/CAPA Change Control Training & Documentation Inspections & Audits processes.

Required Qualifications

• • Bachelors 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 AIenabled 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.

Preferred Qualifications & Skills

• • Familiarity with quality systems such as COMET SUMMIT TruVault VMP and other analytical tools.

  • Experience working in datadriven or digitally enabled quality environments.

  • Strong analytical problemsolving and communication skills.

  • Ability to work effectively in a matrix crossfunctional and global environment.

Why Join CSQ

• • Be part of a highimpact clinical supply quality organization

  • Contribute to riskbased quality governance supporting early and latephase 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.

The anticipated base pay range for this position is EUR 64000 to EUR 103040 on an annual basis and includes 8% holiday allowance

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