Head of Quality Assurance (m/f/d)

#LI-DNI

We are a specialty vaccine company that develops, manufactures, and commercializes prophylactic vaccines for infectious diseases addressing unmet medical needs. We take a highly specialized and targeted approach, applying our deep expertise across multiple vaccine modalities, focused on providing either first-, best- or only-in-class vaccine solutions.

We have a strong track record, having advanced multiple vaccines from early R&D to approvals, and currently market three proprietary travel vaccines, including the world's first and only chikungunya vaccine, as well as certain third-party vaccines.

Revenues from our growing commercial business help fuel the continued advancement of our vaccine pipeline. This includes the only Lyme disease vaccine candidate in advanced clinical development, which is partnered with Pfizer, as well as vaccine candidates against the Zika virus and other global public health threats.

Responsibilities

• Site functional lead for Quality Assurance (QA) and local line management responsibilities for QA
• Recruit, lead and develop local site QA Team
• Cost center management
• Quality oversight of the site (GxP), including CMOs, material and service suppliers
• Ensure inspection readiness of the site
• Responsible for the local QMS and implementation of and adherence to the Global QMS
• Develop, monitor, improve and maintain local standard operating procedures (SOP) and other controlling documents to ensure adherence to the Global QMS as well as compliance with the relevant GMP/GDP regulations
• Oversee batch release duties and support to the Qualified Person (QP) and Responsible Person (RP)
• Drive and oversee that deviations, CAPAs, CCs and other QMS activities are addressed in a GMP/GDP compliant and timely manner
• Ensure quality issues are escalated in an appropriate and timely manner
• Ownership of local Quality Review Board and ensure reporting of quality related KPIs
• Drive and oversee systems for self-inspections, internal audits and supplier audits as well as fulfillment of inspection- and audit-plans
• Take part in or lead Global Quality Focus Groups as per area of expertise
• Provide Quality/GxP guidance/advice at site level
• Lead and engage quality culture at all levels of the organization
• Act as role model for process excellence culture and drive continuous improvement