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Performs quality oversight of BIAL Group and its subcontractors, according to GMDP, applicable guidelines, regulatory requirements, and aligned with the company's strategy.
The Impact You'll Make
- Assure that GMDP operations are carried out in accordance with the applicable guidelines and regulatory requirements (e.g., European and US);
- Contribute to the Audit Program (internal and external) execution;
- Prepare, review, and approve GMDP documents;
- Act as a quality subject matter expert, supporting the quality oversight of BIAL group and its subcontractors;
- Provide GMDP training;
- Manage the electronic Quality Management System;
- Manage quality events;
- Collaborate on quality strategic and continuous improvement projects.
What You'll Bring
- Degree in Pharmaceutical Sciences, Chemical Engineering, or similar;
- Typically 3 to 5 years of experience in a similar role or in a GMP operational area;
- Good knowledge of Quality, cGMP, cGDP, and ICH guidelines;
- Experience in an FDA-approved manufacturing site (preferential);
- Excellent communication skills and ability to enhance partnerships with internal and external stakeholders;
- Analytical mindset with strong attention to detail;
- Capable of setting priorities and quickly solving problems;
- Ability to adapt to a dynamic and fast-paced work environment; experience in cross-functional teams and projects (preferential).
Create Your Path@BIAL
"The innovative projects continue to motivate me, and the people as well because they are incredibly passionate about what they do, very curious, and unafraid to face the unknown."
Seniority level
- Associate
Employment type
- Full-time
Job function
- Quality Assurance
Industries
- Pharmaceutical Manufacturing
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