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.

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Job Function:

Quality

Job Sub Function:

Quality Assurance

Job Category:

Professional

All Job Posting Locations:

Beerse, Antwerp, Belgium

Job Description:

About Innovative Medicine:

Our expertise in Innovative Medicine is informed and passionate about 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 Clinical Supply Quality Laboratories:

The Clinical Supply Quality Laboratories team is part of the Clinical Supply Quality (CSQ) department.

CSQ provides end-to-end Quality & Compliance oversight for the internal and external clinical supply leading up to the release and certification of Investigational Medicinal Products used in clinical trials.

The group is forward-looking, working on improving processes, being customer oriented and supporting innovation and agility.

We are searching for the best talent for the Beerse laboratory team responsible for quality oversight and support of Synthetics laboratories located at Beerse and their contract laboratories.

Sr. QA Associate CSQ Lab

Purpose:

We are looking for a person with an analytical, scientific and quality mindset to join our dynamic multidisciplinary team as a Sr. QA Associate that will be responsible for the Beerse site compliance and operational compliance of the clinical laboratories. The Sr. QA Associate will operationally support the daily activities including review and approval of procedures and documents for the analytical and microbiological activities, support external audits from heath authorities and customers, support/complete internal audits, participate in check rounds to supervise the compliance of the laboratory areas and the performance of the processes and activities, review and approve quality investigations and change controls, provide data for quality metrics in support of quality reporting. The Sr. QA Associate will closely interact with the other CSQ team members, our TDS business partners and other business and quality departments. Together with this exciting function in a dynamic and international environment, we ensure diversity in your work and support personal development.

Your responsibilities:

• Serves as quality point of contact for SMPD Analytical Development and Drug Product Development and their contract laboratories.

• Acts as Quality specialist for assigned analytical techniques and quality processes ensuring an appropriate quality and compliance level by applying risk management in line with the intended use and phase of development.

• Establishes and develops collaborative working relationships within and across SMPD and the global quality organization, including single quality voice in the analytical area

• Reviews and approves laboratory related documents such as validation/transfer/investigation protocols and reports

• Reviews and approves procedures and work instructions

• Handles Quality Issues, Corrective/Preventive Actions, and Change Controls related to the SMPD laboratories as well as their contract laboratories

• Ensures that Quality and Compliance operational targets are met

• Supports quality oversight via periodic quality reviews e.g. internal audits, quality metrics, check rounds.

• Works with the supported departments to maintain and continuously improve the quality culture to positively influence Quality metrics.

• Reports Quality trends and makes a positive contribution via ideas for improvement

• Supports and acts as spokesperson during Health Authority inspections and customer audits

• Travels occasionally for training or business purposes

Required skills

• Experience and affinity with the laboratory environment e.g. method development method validation, release & stability testing, microbiology, pharmaceutical development, instrument qualification, IT, automation

• Ability to work across organizational boundaries through influencing, negotiation and partnering in a global environment.

• General knowledge of pharmaceutical product development and understand how analytics contribute to this process.

• Experience with regulatory inspections as spokesperson, backroom role, preparation is an asset.

• Positively react to changes and show agile behavior e.g. dealing with different quality levels to support fit for purpose quality in an R&D environment.

• Excellent verbal and written communication skills to negotiate and connect with internal and external customers.

• Positively react to changes and show agile behavior e.g. dealing with different quality systems applied by service providers

• Capable of working under time pressure

Education / experience

• Bachelor or Master degree, scientific oriented (pharmaceutical, chemical or biological sciences) or equivalent by experience

• 3-5 years' experience in pharmaceutical industry

Language proficiency

• Excellent verbal and written communication skills (Dutch & English)

IT proficiency

• MS Office suite

Required Skills:

Preferred Skills:

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)

The anticipated base pay range for this position is:

€72 500,00 - €115 230,00

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.