BMclinical, part of the BModesto Group is looking for a Quality Manager. We are looking for a quality conscious and result-oriented specialist. The BModesto Group is an international, ambitious and fast-growing company based in Lelystad. Are you the one we are looking for?
The Quality Manager is responsible for the execution of the day-to-day operations within the Quality Department for BMclinical. The Quality Manager receives guidance from the Director of BMclinical and functional management from the Quality Manager of the BModesto Group. The Quality Manager does not have line management responsibilities.
BMclinical offers a refreshing approach to clinical trial supply. Through experience and collaboration, we offer unrivalled commercial drug sourcing, supply management and global distribution services. Our end goal is to simplify our customer’s supply chains, whilst providing the highest level of service and patient safety.
We are the BModesto Group
A collection of contrarious adventurers, with a sharp eye for details, who work together towards a higher goal: to make a positive contribution to the care and well-being of our loved ones. We therefore work hard every day to ensure optimal availability, accessibility and affordability of healthcare resources in the Netherlands and beyond. How do we do this? By supporting clinical trials with BMclinical, supplying (parallel-imported) medicines to hospitals and pharmacies with BModesto and supplying (parallel-imported) medical devices with BMmedical. As an employee of BMclinical you contribute to this!
This will be your work
- Responsible for maintaining, developing and complying with the quality system of BMclinical;
- Responsible for drafting, reviewing quality documents and identifying gaps;
- Responsible for the generation and maintenance of SOPs, Forms and Work Instructions;
- Provides improvement plans for the processes between BMclinical and BModesto and executes agreed plans;
- Leads quality projects and directs/supports the department heads and BMclinical team;
- Keeps training schedules up to date, gives practical trainings, signals when retraining is needed and keeps accurate records;
- Investigates the root causes of bottlenecks and executes risk analyses together with colleagues;
- Independently proposes improvement plans (substantiated with data) for changes and expansion in the quality system;
- Responsible for the supplier and customer (re)assessment/onboarding;
- Performs internal audits of the entire process independently on a regular basis, identifying deviations, issues and changes and uses the right actions or solutions for improvements and minutes them in a report;
- Responsible for the preparation, execution and elaboration of (system) validations alongside internal IT department;
- Takes the lead on customer and supplier audits;
- Liaise with customers and suppliers regarding quality technical agreements, complaints and procedures;
- Present a quality overview on a quarterly basis to internal stakeholders;
- Be listed as the Responsible Person on the BMclinical license;
- Responsible for the disposition of returned products;
- Keep up to date on industry regulatory changes and discuss with internal stakeholders;
- Acts as a potential back-up for the QO’s in other entities of the BModesto Group;
- Is a team player, result-oriented and knows how to achieve an optimal result together with colleagues;
- Works in accordance with GDP/GMP/GCP guidelines and gives an alert in case of non-compliance with guidelines;
- Performs any other work in the department at the direction of the Director and Quality Manager of BModesto.
This is you!
- Attention to detail, with an accurate, careful and considered approach;
- Quality conscious/ responsible;
- Understanding of the commercial business;
- Flexible and pragmatic mind;
- Strong communication and organisational skills;
- Ability to work independently as well as part of a team.
- Certified Responsible Person in the EU;
- Several years’ experience working in a quality function within the pharmaceutical industry, ideally in Clinical Trial Supply;
- Excellent knowledge of GDP having worked in a GDP environment;
- Experience in making quality-conscious decisions;
- Experience in hosting and performing customer and supplier audits;
- Experience in GMP within clinical trial supply is desirable but not essential.
For you, from the BModesto Group
- Exclusive onboarding box with unique items;
- Competitive salary;
- Awesome company parties;
- Company laptop;
- Lots of fun every day in an enthusiastic team with adventurous and razor-sharp colleagues.
Do you recognize yourself in this profile? Send your resume and motivational letter to firstname.lastname@example.org and maybe we will see you soon!
Do you have any questions about the vacancy? Do not hesitate to contact our HR department by calling +31 320 216 387 or e-mail email@example.com.