Quality Assurance Manager

uniQure; Amsterdam; Hybrid; EUR 90,000 - 140,000; Full time

Benefits offered by this job

Hybrid work model

Equal opportunity employer

Job summary

uniQure is seeking a quality professional to ensure GMP compliance across documentation, protocols, and investigations. You will review and approve deviations, CAPAs, change controls, and risk assessments in collaboration with SMEs across Supply Chain, Manufacturing, QC, Facilities, and Engineering.

This role requires a bachelor’s degree, 6–10 years GMP experience, familiarity with ICH/FDA/EU guidelines, and proficiency in MS Office and electronic QMS; audit experience highly valued.

Qualifications

• Bachelor’s degree required.
• Postgraduate studies in Pharmaceutical Business and/or Technology.
• 6–10 years of GMP experience in pharma/biotech with a quality system.
• Experience working in a GMP manufacturing environment.
• Well versed in cGMP/ICH/FDA/EU regulations.
• Proficient in 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.

Responsibilities

• Review GMP documentation from a quality perspective to ensure compliance.
• Review protocols, data and reports relating to multiple functions for commissioning, qualification/requalification, process/method validation, analytical method transfer, and cGMP activities.
• Review and approve deviations and CAPAs, including risk assessments and root cause investigations.
• Review and approve change controls ensuring quality, validation, procedural, regulatory impact and justified testing.
• Lead quality investigations at CMO/CTLs with SMEs to ensure corrective actions.
• Review and approve OOS and other laboratory investigations including CAPAs.
• Support continuous improvement and oversight of QMS procedures and platforms (Veeva).
• Lead or oversee internal and external audits.
• Provide inspection readiness support for third-party audits and regulatory inspections.
• Support supplier quality via vendor change notifications, part number requests, and raw material specs.
• Maintain Approved Supplier List and implement Quality Agreements with Suppliers.
• Provide metrics on Document Control, Training and QMS performance to Management.
• Collaborate with Quality leaders to ensure compliance with global regulations.

Skills

Strong communication skills

Strong organizational skills

Decision making and problem-solving

Attention to detail

Autonomy / self-management

Team collaboration

Multitasking

Education

Bachelor’s degree

Postgraduate studies in Pharmaceutical Business/Technology

Tools

MS Office

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.

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

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].