Are you passionate about developing in-depth knowledge of GMP standards and fostering a quality mindset in Quality Control within QC for Clinical Production, Design Verification Test Lab, and Investigation Lab for Customer Complaints? Do you enjoy driving quality improvement initiatives and engaging with many stakeholders across a department in an ever-changing and growing environment, to discover the best solutions? If this sounds like your ideal position, then the Senior GMP Expert opportunity in Device Manufacturing Development (DMD), Product Control and Global Support will be the perfect fit for you!
The position
As a Senior GMP Expert in Product Control and Global Support, your role involves managing different quality related activities across the department. Occasionally also across DMD. The nature of these activities can vary, ranging from those closely tied to enhancing our local laboratory processes to those associated with more cross functional activities in our development processes of our Devices and Combination Products. Depending on the quality activity, you will take the lead in guiding team members of highly skilled technicians and Engineers in charge of developing and optimizing systems and processes. You will have a holistic and pragmatic view in ensuring a high level of quality and compliance within Product Control and Global Support. This will involve setting appropriate standards anchored in our Quality Management System (QMS), enabling us to meet all relevant GMP requirements and implementing efficient structures to prepare for future audits and inspections.
You will be focusing on:
In this position, you will have a high level of independence, guiding and teaching the department, colleagues, and management.
Qualifications
To succeed in this role, we imagine you:
On a personal level, you see yourself as being self-driven, independent, proactive and solution oriented. You are a strong communicator who works systematically and strive for simplicity. You enjoy collaboration, thrive building networks and working with individuals at all levels of the organisation.
About the department
You will be part of DMD, Product Control & Global Support, where we assist device development from the early R&D development stages into production for clinical trials and eventually into production to market. Reporting to the Senior Manager of Projects and Product Control Development, you will be a member of a diverse team of highly skilled professionals, Specialists and Project managers who also working across the department and the organisation.
As a high-potential collaborator in our department, you will embrace significant responsibility and receive guidance to foster your personal and professional growth. You will work alongside positive and agile colleagues who will share their expertise to for future challenges. Our diverse team includes international colleagues with various backgrounds and experiences.
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