Associate Director, QC Data Management

Role Summary

Associate Director, QC Data Management responsible for overseeing QC data management processes across development phases (clinical and commercial) for uniQure’s gene therapy products, with a focus on data integrity, governance, and timely product release.

Responsibilities

• Developing/continuously improving the overall data management strategy within the context of an outsourcing model (testing performed by CLOs).
• Working with data integrity & reliability experts to provide a framework for internal and external QC data generation, acquisition, and reporting.
• Mentoring on data management within QC and within the broader organization.
• Gathering program-specific data into data overviews used for communication, study reports, and regulatory submissions.
• Partnering with internal and external teams to meet timelines and objectives; collaborate within QC/QA to enable timely release and supply of products.
• Supporting QC quality events such as change controls, deviations, stability trends, OOS/OOT/OOE investigations, root cause analysis, and CAPAs.
• Presenting QC data findings to senior management, highlighting trends and opportunities for improvement.
• Providing technical input to study reports and regulatory submissions to ensure data accuracy and proper interpretation.

Qualifications

• 8+ years of analytical and/or quality control experience in a clinical and commercial Biotech and/or Pharmaceutical company under GMP environment
• Advanced degree (PhD or MSc) in Life Sciences or equivalent experience
• Strong experience with data management, data management strategies
• Experience with CLOs/CDMOs and obtaining QC data from external sources
• Experience with analytical methods related to cell & gene therapy products
• Strong knowledge of QC principles, industry standards, and cGMP regulations
• Regulatory knowledge (ICH/FDA/EMA/USP/Ph. Eur.)
• Skilled in investigations and root cause analysis
• Excellent written and verbal communication and interpersonal skills
• Ability to work independently with minimal supervision and collaborate across groups
• Strong attention to detail and results-driven mindset
• Hybrid role based in Lexington, MA; onsite minimum 3 days/week; some travel to CLOs/CROs/CDMOs or Amsterdam site may be required

Skills

• Data management strategies
• QC data generation, acquisition, and reporting
• Deviations, investigations, CAPAs
• Regulatory submissions support
• Cross-functional collaboration
• Change controls and deviations management

Education

• Advanced degree (PhD or MSc) in Life Sciences or equivalent

Additional Requirements

• Onsite at Lexington, MA minimum 3 days per week; some travel may be required