GMP Quality Assurance Lead - Audits & Compliance

UniQure NV; Amsterdam; Hybrid; EUR 90.000 - 140.000; Vollzeit

Benefits dieser Stelle

Hybrid work model

Equal opportunity employer

Zusammenfassung

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.

Qualifikationen

• 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.

Aufgaben

• 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.

Kenntnisse

Strong communication skills

Strong organizational skills

Decision making and problem-solving

Attention to detail

Autonomy / self-management

Team collaboration

Multitasking

Ausbildung

Bachelor’s degree

Postgraduate studies in Pharmaceutical Business/Technology

Tools

MS Office

Electronic QMS

Jobbeschreibung

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.