Associate Director, Quality Control

uniQure; 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

Place in the Organization

At uniQure, we are delivering on the promise of gene therapy and delivering hope for patients facing urgent unmet medical needs. Every role in our organization carries profound purpose; whether you're in research, operations, access, or support, your contributions impact patients. We're seeking passionate professionals who thrive in high-stakes environments, uphold rigorous quality standards, and share our relentless commitment to transforming the lives of patients. Join us in making the impossible possible, where your expertise becomes a catalyst for life-changing treatments.

Place in the Organization

At uniQure, we are delivering on the promise of gene therapy and delivering hope for patients facing urgent unmet medical needs. Every role in our organization carries profound purpose; whether you're in research, operations, access, or support, your contributions impact patients. We're seeking passionate professionals who thrive in high-stakes environments, uphold rigorous quality standards, and share our relentless commitment to transforming the lives of patients. Join us in making the impossible possible, where your expertise becomes a catalyst for life-changing treatments.

The Associate Director, Quality Control is responsible for managing all operational activities for in-process, release, and stability testing for clinical and commercial products. The candidate will be responsible for relationship management, Contract Testing Organization (CTO) selection, and CTO strategies. This position works closely with Operations, Quality Assurance, and Regulatory Affairs to develop and maintain a comprehensive program that ensures consistent quality throughout the production platform and lifecycle.

Key Result Areas (major Duties, Accountabilities, And Responsibilities)

• Responsible for external quality testing at CTO’s (including in-process, release, and stability); ensures complete documentation for compliance with cGMPs
• Maintains relationships with CTO’s to ensure Quality Agreements, Statement of Work (SOW), and Manufacturing Service Agreements (MSA) are initiated and updated accordingly
• 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

Qualifications

• Bachelor’s degree in Scientific discipline
• 10 - 12 years of relevant GMP experience in pharma/biotech company
• 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

Core competencies

• Strong communication skills
• Strong organizational skills
• Decision making and problem solving skills
• Attention to detail
• Capable of working with minimal supervision
• Ability to work well with diverse groups
• Ability to manage multiple activities with challenging timelines

The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant, relevant years of experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from where they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.

US Salary Range

$188,000—$228,000 USD

uniQure is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, sexual orientation, or gender identity), national origin, age, disability, genetic information, marital status, veteran or military status, or any other characteristic protected by applicable federal, state, or local laws. If you need assistance or a reasonable accommodation during the application process, please contact [e-mail].