Life Sciences Quality Auditor

at  Deloitte

DESCRIPTION OF THE POSITION

Can’t wait to make an impact on the world? You’re not alone. Join us in driving progress in the working world and beyond.

YOUR JOURNEY WITH US

For our life science regulatory compliance team, we are looking for an Experienced Auditor with a scientific background, who has experience conducting quality audits in the Life Sciences industry, is familiar with GxP standards such as Good Manufacturing Practices, and is passionate about Innovative Medicines, Regulatory, Compliance, Regulatory Affairs, Medical Affairs and/or Medical Devices.

Role description:

• Participating in end-to-end quality audit processes (from audit preparation to execution and reporting)
• Leading audits in EMEA, to assess compliance with regulatory requirements (GxP such as GMP, GCP, GPV, GLP, etc.) in the field of Advanced Therapeutic Medicinal Product (ATMP) manufacturing;
• Leading Regulatory Compliance projects;
• Providing Regulatory Compliance guidance, expertise and support; and
• Supporting the creation regulatory strategies.

We are currently seeking ambitious team players with a good knowledge on regulatory topics and a well-rounded personality to become part of our dynamic Quality & Compliance team in our offices in Belgium.
Join our team and you will operate at the cutting edge, enjoying the kind of professional development that will set your potential free.

TECHNICAL REQUIREMENTS:

• A background in either biology, immunology, chemistry, biomedical sciences, biotechnology, or bio-engineering;
• At least 5 years of experience in life sciences/healthcare industry;
• At least 3 years of audit experience;
• Proven experience with Regulatory Compliance in Life Sciences and preferably also in the field of ATMPs;
• Able to translate regulations and regulatory requirements into business requirements;
• Good understanding of Regulatory Information Management Systems and Quality Management Systems;
• Proven experience with at least two of the following GxP areas:
• Good Manufacturing Practices (GMP);
• Good Clinical Practices (GCP);
• Good Laboratory Practices (GLP);
• Good Pharmacovigilance Practices (GPV);
• Good Distribution Practices (GDP); and
• The EU Medical Device Regulation (EU MDR) and ISO13485.

GENERAL REQUIREMENTS:

• You are fluent in English; French or Dutch are a plus;
• You are an excellent communicator and can communicate effectively with stakeholders at all levels and from different departments (business users, IT project leaders, leadership, etc.);
• You are able to convey impactful presentations to our clients;
• You are able to plan and execute a project to deliver a superior client experience;
• Eager to build in-depth knowledge of the client’s business and stay up-to-date on industry activities, marketplace trends, innovation efforts, and leading practices;
• Willing to travel abroad throughout Europe to conduct onsite audits; and
• You have an analytical mindset, always looking to broaden your expertise.

• Participating in end-to-end quality audit processes (from audit preparation to execution and reporting)
• Leading audits in EMEA, to assess compliance with regulatory requirements (GxP such as GMP, GCP, GPV, GLP, etc.) in the field of Advanced Therapeutic Medicinal Product (ATMP) manufacturing;
• Leading Regulatory Compliance projects;
• Providing Regulatory Compliance guidance, expertise and support; and
• Supporting the creation regulatory strategies