Associate Director, Quality Control
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.
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
#LI-Hybrid
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.
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 careers@uniqure.com.
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 careers@uniqure.com.
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.
Skills
As published by greenhouse · 11 questions
Basics
First Name, Last Name, Email, Phone, Resume/CV, Cover Letter, Location
Short answers (6)
- Preferred First Name optional
- Address
- City
- Zipcode
- Desired Salary
- LinkedIn Profile optional
Pick from a list (5)
- State
- Do you have work authorization to work in the U.S. for any employer?
- Do you now or will you in the future require sponsorship, including H-1B/TN/O-1/E-3 sponsorship or I-485 portability?
- Are you able to work out of the Lexington office 3 days/week?
- Do you have 8+ years of relevant GMP experience in the pharma/biotech industry?