Associate Quality Systems Audits and Inspections

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through 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 humanity. Learn more at jnj.com .

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.

Job Function:

Non-Standard

Job Sub Function:

Workday Associate 01

Job Category:

Non-Standard

All Job Posting Locations:

Beerse, Antwerp, Belgium

Job Description:

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 https://www.jnj.com/innovative-medicine

About the Role

We are seeking a detail-oriented Associate, CSQ Quality Systems – Audits & Inspections to join our Clinical Supply Quality (CSQ) team. This role is supporting the Sr Associate in planning and coordination of internal and external audits and for the preparation of inspections by health authorities across CSQ, including Beerse (DPDS), Leiden (ex-Vaccines), and External Clinical Supply Quality (ECSQ). The ideal candidate brings solid expertise in GxP quality systems, audit management, and inspection readiness, with a strong focus on planning, documentation, and cross-site coordination.

Key Responsibilities

Audit Planning & Coordination: Support in the maintenance, scheduling and execution of the annual internal and external audit plan across CSQ (Beerse DPDS, Leiden ex-Vaccines, and ECSQ), ensuring identified lead and support auditors, and timely scheduling as per approved audit plan(s).

Internal Audits: Support the execution of internal (self-inspection) audits, tracking scope, timelines, findings, and completion of corrective and preventive actions (CAPAs).

External Audits: Support the coordination of external audits of suppliers, contract manufacturers, and service providers, aligning stakeholders and consolidating outcomes.

Inspection Readiness: Support Sr Associate in the preparation for inspections by health authorities, ensuring sites and teams are inspection-ready through gap assessments, mock inspections, and documentation reviews.

Inspection Support: Provide logistical and documentation support during health authority inspections, including management of front-room/back-room activities and request tracking.

CAPA & Follow-up: Monitor audit and inspection findings to closure, ensuring responses and CAPAs are robust, timely, and inspection-defensible.

Metrics & Reporting: Track and report key audit and inspection metrics (KPIs), providing actionable insights and status updates to CSQ leadership.

Documentation & Compliance: Maintain accurate, complete, and audit-ready records in alignment with GxP requirements, ALCOA+ principles, and J&J global standards.

Qualifications

Bachelor’s degree in Life Sciences, Pharmacy, Engineering, or a related field; advanced degree preferred.

Minimum 2 – 4 years of experience in quality assurance, quality systems, or audits and inspections within a regulated environment (e.g., pharma, biotech).

Strong knowledge of GxP regulations, ICH guidelines, and health authority inspection expectations (e.g., FDA, EMA).

Demonstrated experience in audit planning, execution, and inspection readiness; auditor certification is a plus.

Experience with electronic quality systems (e.g., COMET, Veeva, TruVault, SUMMIT or similar) and data reporting tools (e.g., Power BI, Quickbase, Tableau).

Excellent organizational, analytical, and communication skills, with the ability to manage multiple priorities across sites.

Dutch and English proficiency is a must; additional European languages are an asset.

What We Offer

A collaborative and mission-driven team environment

Opportunities for professional growth and career development

A dynamic and inclusive workplace environment

Competitive compensation and benefits package

The chance to make a meaningful impact on clinical supply quality and patient outcomes.

At Johnson & Johnson, we want every candidate to feel supported throughout the hiring process. Our goal is to make the experience clear, fair, and respectful of your time.

Here’s what you can expect:

Application review: We’ll carefully review your CV to see how your skills and experience align with the role.

Getting to know you: If there’s a good match, you’ll be invited to a short call with one of our recruitment team to understand more about you and answer any questions that you might have.

Staying informed: We know waiting can be hard and processes can evolve; our recruitment team will keep you updated and make sure you know what to expect at each step.

Final steps: For successful candidates, you will need to complete country-specific checks before starting your new role. We will help guide you through these.

Finally, at the end of the process, we’ll invite you to share feedback in a short survey, your input helps us continue improving the experience for future candidates. Thank you for considering a career with Johnson & Johnson. We’re excited to learn more about you and wish you the best of luck in the process! #RPOEMEA

Required Skills:

Preferred Skills:

The anticipated base pay range for this position is:

€0,00 - €0,00

Benefits:

In addition to base pay, we offer the following benefits*: an annual bonus with set target (% of pay) depending on pay grade / location, where the actual amount is based on the employees’ and companies’ performance of the previous calendar year, or sales commissions. Moreover, we offer vacation days, parental leave for a minimum of 12 weeks, bereavement leave, caregiver leave, volunteer leave, well-being reimbursement, programs for financial, physical and mental health. We also offer service anniversary and recognition awards, and subject to the terms of their respective plans, employees - and in some location’s eligible dependents - can participate in several insurance plans. For more information, visit Employee benefits | Supporting well-being & career growth | Johnson & Johnson Careers.

*This is for informative purposes only. Amounts and actual benefits may vary by location and are subject to change.