Hybrid QC Associate Director - GMP/CTO Oversight

UniQure Biopharma B.V.; Lexington (MA); Hybrid; USD 188,000 - 228,000; Full time

Benefits offered by this job

Hybrid work

Job summary

uniQure is seeking an Associate Director, Quality Control to lead external QA testing at CTOs and ensure compliant processes for in-process, release, and stability testing across clinical and commercial products.

You will manage CTO relationships, quality agreements, SOWs, and MSAs while overseeing budgeting and change-control activities within a collaborative, cross-functional environment.

Qualifications

• Bachelor’s degree in a scientific discipline.
• 10–12 years of GMP experience in pharma/biotech.
• Experience working in a GMP testing environment.
• Experience managing CTO’s.
• Well versed in cGMP/ICH/FDA/EU regulations and guidelines.
• Proficient in using Microsoft applications (MS Word, MS Excel, MS PowerPoint).
• Proficient in an electronic document management system/electronic QMS.
• Experience using Risk Management Tools such as FMEA, 5Ms, 5 Whys, etc.
• Project management skills preferred.

Responsibilities

• Oversee external QA testing at CTO’s and ensure compliant documentation.
• Maintains relationships with CTO’s to ensure Quality Agreements, SOW, and MSA are initiated and updated.
• Oversee testing programs including: Assay Controls, Starting Materials, Reference Standards, Product Release, Stability.
• Oversees budgeting for CTO’s; including contracts and purchase orders.
• Support and facilitate deviations and investigations.
• Support long-term planning of QC lab capabilities and capacity.
• Responsible for coordinating with AD and QCTS for the implementation of new technologies into CTO network.
• Change notification management.
• Data analysis for release data.
• Coordination and drafting of Annual Product Review sections.
• Coordination of Annual Method Reviews
• Coordination/review of compendial methods for compliance.
• Active participant in the management and direction of the overall QC programs and requirements.

Skills

GMP experience

Quality control

CTO management

cGMP/ICH/FDA/EU regulations

Project management

MS Office proficiency

QMS experience

Attention to detail

Education

Bachelor’s degree in Scientific discipline

Tools

MS Word

MS Excel

MS PowerPoint

Electronic QMS

FMEA

5Whys

5Ms

Job description

uniQure is seeking an Associate Director, Quality Control to lead external QA testing at CTOs and ensure compliant processes for in-process, release, and stability testing across clinical and commercial products.

You will manage CTO relationships, quality agreements, SOWs, and MSAs while overseeing budgeting and change-control activities within a collaborative, cross-functional environment.