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Head of Quality Assurance
vor 4 Monaten
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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 improvementRequirements
Minimum Bachelor Degree in Natural Sciences, with extensive work experience (5+ years) in the Life science or Pharmaceutical industry Extensive work experience within Quality Assurance and Quality Control in GxP (GMP, GDP, GCP, GCLP) regulated Life Science or Pharmaceutical industry Experience in hosting authority inspections Profound knowledge of relevant GxP (GMP, GDP, GCP, GCLP) legislation for the EU, US and Canadian territories Used to work in an international environment with various cultures is desirable Strong management and leadership skills with ability to motivate and engage High standards and knowledge with regards to all quality and regulatory related standards, regulations and internal procedures Experience in Lean Management, open-minded team-player and able to work cross functional Good communication and influencing skills (especially in English) Proactive, solution-oriented and able to react in a fast changing environment Able to make timely, balanced and compliant decisions aligned with business needs Ability to analyse information in a structured way, to manage and prioritise workload both for the organisation as well as on a personal levelBenefits
Open, appreciative company culture with innovative spirit and attractive assignments International surrounding with flat hierarchies Good team spirit in a strong and highly motivated team Wide range of benefits like flexitime, compensation days, performance-related bonus, lunch vouchers, child care center (“Kindergarten”), company events, myClubs, etc.Due to legal reasons we are obliged to disclose the minimum salary for this position, which is € ,- gross per year based on full-time employment. However our salaries are market oriented and in line with your qualifications and experience.
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