New · posted Oct 31
UniQure Biopharma B.V. · Biotechnology
Associate Director, Quality Control
- Lexington, MA
- Hybrid
- Full-time
- Director
The role
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.
What you need
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
- 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 posts all open positions exclusively on our official Careers page and LinkedIn. We do not recruit through any other job boards, third-party websites, or unsolicited outreach via text or messaging apps. All legitimate communication from uniQure’s Talent Acquisition team will come from an @uniqure.com email address. We will never request financial information nor payment of any kind during the application process. If you receive suspicious outreach claiming to be from uniQure, do not respond or share personal information. Inquiries can be made via [email protected].
Pay
$188,000 – $228,000 a year
Employer providedWhere you'll work
Lexington, MAHybridOpen in Maps (opens in a new tab)
More jobs in Lexington, MAEqual opportunity, accessibility and legal noticesUniQure Biopharma B.V.'s statements, word for word
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 [email protected].
uniQure processes personal data submitted through this application for recruitment and hiring purposes only. Depending on your location, you may have specific rights regarding your personal data. For full details on how we collect, use, store, and protect your information — including disclosures for California residents under the CCPA and for applicants under the GDPR — please review our applicant privacy notice.
Job intelligence
The context around this role
Live data · October 31, 2026
Salary intelligence
How the pay compares
This role's midpoint is 5% above the US median for Quality Control roles at this level.
This roleEmployer provided
Director roles in Massachusetts7 roles publishing pay
Director roles in the US25 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $188,000 | — | $228,000 |
| Massachusetts (middle half) | $193,250 | $215,500 | $258,750 |
| All US (middle half) | $188,000 | $198,500 | $245,000 |
This role: UniQure Biopharma B.V.'s own published range. Comparisons: the base pay employers published on open Quality Control roles at the same level on Regulatory Jobs, October 31, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Quality Control
The general path across 345 open Quality Control roles on Regulatory Jobs, with the titles they carry most. Not uniQure's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 35 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Lab testing and methods6
- GMP and compliance5
- Documentation and SOPs2
- Quality systems and risk2
- Collaboration and leadership2
- Investigations and CAPA1
- Data and digital systems1
Regulatory intelligence
The rules behind this role
Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.
- FDA21 CFR Parts 210 and 211(official source, opens in a new tab)FDA current good manufacturing practice for finished pharmaceuticals
- ICHICH quality guidelines(official source, opens in a new tab)Q1 stability, Q2(R2) analytical validation, Q7, Q9 risk management, Q10 quality systems
- USPUSP compendial chapters(official source, opens in a new tab)Bioburden (USP <61>), endotoxin (USP <85>), TOC (USP <643>) and water testing
Company hiring pulse
uniQure on Regulatory Jobs
- 5
- Open roles
- 5
- Distinct roles
- 2
- Locations
By discipline
- Regulatory2 40%
- Quality2 40%
- Clinical1 20%
By level
- Director3 60%
- VP & Executive2 40%
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Associate Director, Quality Control at uniQure
Open until filled. $188K–$228K a year, employer provided.