Operational Quality Manager

At SGS, you can choose. First of all, out of our various vacancies.
However, SGS also gives you another choice.
Do you choose to expand or to enrich? We are not only looking for colleagues who can go in to depths of their discipline. We are equally as much looking for colleagues who we call ‘connectors’, people who can connect our diversity to our services. To each other. And this way, enrich our business.

SGS is the world’s leading inspection, verification, testing and certification company. We’re also the worldwide benchmark for quality and integrity. And that makes us very proud. This can only happen thanks to more than 90 000 colleagues worldwide, with 1650 employees in Belgium only. Our employees give 110% of themselves every day, divided over all expertises, branches and cultures. Our coworkers build their own way inside the company, the services and the expertise.

The Quality Assurance Department is an independent department within SGS Clinical Research. It is responsible for the Quality Management System, which covers all quality documents, training and qualification, resolution and documentation of deviations, auditing activities and dedicated quality support to all operational teams (i.e. Clinical Pharmacology Unit (CPU), Business Development and Support, Clinical Operations, Biometrics and Medical Safety & Regulatory (including Business Technology, Data Technology and Document Management)).

We are currently looking for an Operational Quality Manager (Edegem)

As Operational Quality Manager (OQM) you are welcomed in a smaller, amiable, and enthusiastic
QA team where you will have day-to-day interaction with other QA experts in the field, such as other OQMs, Quality Compliance Managers, Auditors, …

As OQM, you will be an indispensable partner of the operational teams - specifically at our Clinical Pharmacology Unit (CPU) in Edegem - in the management of their part of the quality system. As such, you will gain insight into the different investigator site processes applicable for the conduct of clinical trials for pharma and biotech companies from start to finish.

Your responsibilities:

Your main responsibilities are the following:

• Collaborate with the assigned operational teams at CPU to improve quality and maintain high quality standards throughout the organization by:
  • Developing and maintaining operational quality (SOPs, WIs, CDs, and manuals and various guidance documents) and personnel documents
  • Leading the non-conformance management process by guiding the teams through the risk assessment of non-conformances, Root Cause Analyses and formulation of CAPA Plans or corrections
  • Supporting the teams by providing additional explanation on topics relating to quality documents/process improvements, development of trainings (eLearnings, classroom trainings) together with the QA training department
  • Proposing changes to operational quality documents and associated training to improve the quality system
  • Initiating process improvements / efficiencies where needed
  • Supporting the teams in performing their daily work in a consistent and efficient way, by the creation of operational checklists, guidance documents, etc.
• As assigned, assist in the further development of the new SGS CR electronic Quality Management System.
• In general, participate in / facilitate cross-functional discussions and working groups related to any aspect of quality at the CPU, to create or optimize cross-functional procedures, or to look for efficiencies in processes, systems, and collaboration.

What do you need to be successful in this role?!

• Minimum of 2 years of experience in a site, CRO or university research (department, laboratory) setting, or in a pharmaceutical, biotech, medical devices (or similar) company, or equivalent by combination of education, training and experience
• Good knowledge of ICH-GCP and good documentation practices are a plus
• Experience in an investigator site setting is considered to be a significant asset!
• Fluently writing and speaking English and very good knowledge of Dutch is a must!
• Excellent communication and problem-solving skills
• Strong organizational skills
• Proficient in writing
• Good knowledge of MS office
• Assertive and motivated, stress resistant and flexible
• Open for discussion and constructive attitude
• Strive for quality and eye for detail

Important note: we cannot support a work permit.
Candidates must already be resident in Belgium!
 

Were you already considering a big switch in your career?
Maybe this could be your next step!

At SGS we can offer you the following:

• An interesting position where you can take responsibility
• An open work atmosphere in an international setting with equal opportunities for all employees
• A dynamic environment that fosters (digital) innovation and inspires employees to drive the business forward proactively and generate success
• Opportunities for personal development by continued education
• Good work-life balance with possibility of working from home
• Coffee corners
• Regular social events
• A permanent contract with competitive salary package (incl. company car, work laptop/cellphone, retirement plan, meal vouchers, …)
  
  We are looking for someone who is passionate about quality and ready to work on exciting projects within Clinical Research. If you are looking to advance your career, enhance your skills and build connections, this position is definitely for you!

Do you want to be part of this?

We are looking forward hearing from you!
Send us your story and your resume via the apply button and maybe you will soon join us for work and coffee breaks.

Still have questions? Heidi Aerts can give you more details about the job ([email protected]).