Industria Farmaceutica-Jobs in United States

Quality Assurance Director CDMO Job Description

This role involves leading a QA team in a contract development and manufacturing organization (CDMO) environment. The successful candidate will oversee regulatory compliance and quality control activities, ensuring full adherence to FDA and GMP standards.

The main responsibilities of this position include :

• Leading a QA team in a dynamic setting.
• Overseeing regulatory compliance and quality control activities.
• Supporting clients in preparing for Pre-approval Inspection (PPQ) and FDA submission.
• Ensuring compliance with current GMP regulations.

Key qualifications for this role include :

• Strong QA experience in the pharmaceutical industry.
• Background working with clients in clinical and development phases.
• Solid understanding of regulatory processes, especially with the FDA.
• Proven leadership skills to manage multidisciplinary teams in dynamic settings.
• Fluency in both Spanish and English.

Benefits of this position include :

• Opportunity to make a real impact on regulatory submissions for the U.S. FDA.
• Relocation support available for the right candidate.
• Chance to work directly with a key client in Valencia, Spain.

Please note that this is a 6-month contract to lead a strategic QA project onsite. We are reviewing applicants on an ongoing basis. To apply, please submit your resume or CV with a few sentences about why you are applying.