Quality Assurance Manager

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 Quality Assurance Manager supports the day-to-day quality operations of all elements of the Quality Management System (QMS), including but not limited to deviations, Corrective and Preventive Actions (CAPAs), investigations, excursions, Out of Specifications (OOS), change control, internal audits, and data integrity for all GMP departments. The incumbent makes quality decisions and performs problem solving, however high-risk items such as major and critical deviations, change controls and CAPAs will require input and agreement from the head of the department.

Key result areas (major duties, accountabilities, and responsibilities)

• Perform reviews of GMP documentation from a quality perspective to ensure compliance to GMP requirements.
• Perform reviews of protocols, data and reports relating to Supply Chain, Ext. MFG,   QC,   Facilities,   and   Engineering   for   commissioning   and qualification/requalification,  process/method  validation,  analytical  method transfer protocols and data/reports relating to compendial testing, and other cGMP activities from a quality perspective to ensure compliance to GMP requirements and sound technical rational.
• Review and approve deviations and CAPAs, including performing Failure Mode Effect Analyses (risk assessments) where applicable, participating in root cause analysis  investigations,  evaluating CAPA  effectiveness,  and  oversight  of departmental training.
• Review and approve change controls ensuring quality impact, validation impact, procedural impact, regulatory impact, and prescribed testing is adequate and well justified.
• Leads quality investigations at CMO/CTLs in conjunction with appropriate SMEs to ensure that all critical and major quality issues are thoroughly investigated with appropriate corrective actions.
• Review and approve Out of Specifications and other Laboratory investigations including subsequent deviations and CAPAs.
• Support the continuous improvement and oversight of Quality Management System procedures and platforms (Veeva).
• Lead or oversee internal and external audits.
• Provide inspection readiness support for third-party audits and regulatory inspections.
• Support the supplier quality program through review and approval of vendor change notifications, part number requests, and raw material specifications, as necessary.
• Maintain Approved Suppler List and responsible for implementing and maintaining Quality Agreements with Suppliers.
• Provide metrics related to Document Control, Training, and QMS metrics including, but not limited to, those related to deviations, CAPA, Change Controls, OOS, and external audits performance to Management.
• Collaborate with other Quality leaders to ensure compliance with all relevant Quality Management Systems and processes are maintained and in line with global regulations and in alignment with the company's strategy.

Qualifications

• A minimum of a bachelor’s degree.
• Post graduate studies in Pharmaceutical Business and/ or Technology
• 6 - 10 years of relevant GMP experience in pharma/biotech company, working within a quality system and regulated GMP environment
• Experience working in a GMP manufacturing environment
• 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 is highly preferred
• Experience using Risk Management Tools such as FMEA, 5Ms, 5 Whys, etc.
• Internal and/or External audit experience is 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