Associate Director, QC & External Testing

UniQure NV; Lexington (MA); On-site; USD 188,000 - 228,000; Full time

Job summary

uniQure, a leader in gene therapy, seeks an Associate Director, Quality Control to oversee in-process, release, and stability testing for clinical and commercial products. You will partner with Operations, QA, and Regulatory Affairs to maintain a robust QC program across the production lifecycle.

You will manage CTO relationships, SOWs and MSAs, coordinate annual reviews, implement new technologies, and lead deviation investigations while ensuring timely data analysis and reporting.

Qualifications

• Bachelor’s degree in a scientific discipline.
• 10–12 years of GMP experience in pharma/biotech.
• Experience in a GMP testing environment.
• Experience managing CTOs.
• Well versed in cGMP/ICH/FDA/EU regulations and guidelines.
• Proficient in Microsoft Office applications.
• Experience using risk management tools (FMEA, 5Ms, 5 Whys).
• Project management experience preferred.

Responsibilities

• Manage external quality testing at CTOs including documentation for CGMPs.
• Maintain CTO relationships and manage SOW, MSAs.
• Oversee testing programs: Assay Controls, Starting Materials, Reference Standards, Product Release, Stability.
• Oversee CTO budgeting incl contracts and purchase orders.
• Support deviations and investigations.
• Coordinate implementation of new technologies into CTO network.

Skills

Strong communication skills

Strong organizational skills

Decision making and problem solving

Attention to detail

Capable of working with minimal superv

Diversity collaboration

Managing multiple activities

Education

Bachelor’s degree in scientific discipline

Tools

MS Word

MS Excel

MS PowerPoint

Electronic QMS

Job description

uniQure, a leader in gene therapy, seeks an Associate Director, Quality Control to oversee in-process, release, and stability testing for clinical and commercial products. You will partner with Operations, QA, and Regulatory Affairs to maintain a robust QC program across the production lifecycle.

You will manage CTO relationships, SOWs and MSAs, coordinate annual reviews, implement new technologies, and lead deviation investigations while ensuring timely data analysis and reporting.