Senior QA Associate Commercial

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.

Job Function:

Job Sub Function:

Job Category:

All Job Posting Locations:

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 Johnson & Johnson Innovative Medicine Supply Chain we are recruiting aSenior QA Associate Commercial.You will be a member of our QA commercial API team overseeing Small Molecule Active Pharmaceutical Ingredients (Synthetics) based in Geel Belgium. You will be part of an enthusiastic team responsible for the quality oversight of the production plants and timely release of commercial APIs ensuring compliance with applicable regulations.

Innovative Medicine Supply Chain Geel serves as Centre of Excellence for the development and manufacturing of Synthetics used in treatments that improve the health and lifestyle of people worldwide. Innovative Medicine Supply Chain Quality supports the Geel site in its mission as Launch & Grow site.

As a Senior QA Associate Commercial Synthetics you are responsible for the quality oversight and timely release of an assigned product portfolio of commercial APIs ensuring compliance with applicable regulations. You will also provide quality support to the production plants.

We are looking for a Senior QA Associate Commercial who is responsible to:

• Build and sustain strong partnerships with Business and Quality stakeholders to ensure alignment of objectives and results. Promote and strengthen the quality culture by providing coaching and training on cGMP requirements.
• Have Quality oversight of commercial APIs manufactured at the Supply Chain site in Geel.
• Work as one team with QA and Supply Chain partners ensuring timely release in support of a reliable supply chain.

• Ensure that nonconformances CAPAs Change Controls and Product Quality Complaints are thoroughly and timely investigated by providing quality compliance and technical expertise meeting internal and external customer expectations.
• Ensure that nonconformances and complaints with potential impact on patient safety and/or product supply are appropriately addressed and escalated.
• Review and approve Annual Product Review (APR) and Continued Process Verification (CPV) reports for the assigned product portfolio of commercial APIs.
• Review and approve GMP documentation such as procedures work instructions protocols and reports.
• Serve as Subject Matter Expert for assigned Quality Processes.
• Act as spokesperson during Health Authority inspections and customer audits.
• Drive a culture of innovation within Quality activities by benchmarking training and participating in industry forums. Challenge the status quo by identifying opportunities for continuous improvement and lead the implementation of initiatives that enhance organizational quality and compliance performance.
• Take part in the standby / on-call rotation outside regular office hours (evenings and weekends) to support 24/7 manufacturing operations and ensure timelyquality decision-making during continuous production.

We would love to hear from YOU if you have the following essential requirements:

• Master Scientific degree (chemistry pharmaceutical sciences bioengineer ).
• Experience in Chemical and/or Pharmaceutical Supply Chain and/or Quality Assurance and experience as release responsible is an asset.
• Demonstrated ability to work independently while staying connected with key stakeholders.
• Demonstrated ability to work across organizational boundaries through influencing negotiation and partnering. Negotiation communication and presentation skills across all levels of the organization are important.
• Strong analytical thinking skills and able to work in a flexible way under time pressure.
• Ability to make riskbased decisions in a timely manner and understand the business implications of qualityrelated decisions.
• In-depth knowledge in cGMP (domestic & international) ICH guidelines policies standards and procedures.
• Experience with Quality Systems.
• Experience with regulatory inspections and preparedness.
• Fluent in Dutch and English both spoken and written.
• Strong team player

Are you ready to make an impact

If you want to leave your personal mark and be valued for who you are Johnson & Johnson offers an unusual experience to professionals looking for an opportunity to work with hardworking people who share your real passion for caring in an environment that empowers you to drive your own career and that you feel you can bring your whole self to work.

We provide you an environment to fulfil your career aspirations as well as promoting your physical and mental wellbeing. You will receive a competitive compensation and benefits package as well as benefits that can be tailored to what is valuable to you throughout different stages of your life.

Required Skills:

Preferred Skills: