Senior Quality Assurance Manager CMO (m/f/d)
Valneva, Austria
Job Description
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 Ramp;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
- Work as primary Quality Assurance point of contact to internal and external partners (Contract Manufacturing Organizations (CMOs), other Valneva sites)
- Lead/support projects in the life-cycle of Valneva’s products at external partners from a QA perspective
- Perform review,QA approval and administration of external documents (e.g. Reports, Deviations, Changes)
- Take over responsibilities for certain Valneva’s Quality Systems
- Responsible for the maintenance and continuous improvement of QM-Systems related to the oversight of external partners/CMOs (e.g. handling of external non-conformance records, documents and Change Controls)
- Interact with QP's as well as other internal stakeholders regarding Quality Oversight of CMO operations for marketed products
- Tracking and reporting of key performance indicators
- Participate in compilation of Product Quality Reviews
- Contribute to the continuous improvement of the quality assurance management system for all aspects of the activities of Valneva Austria, compliant with coordinated policies for Quality Assurance which are consistent with current GMDPs, relevant Health and Safety Regulations and other relevant current legislation
- Actively support Quality Assurance activities related to administration amp; training of Quality Systems
Requirements
- HTL, Bachelor or Master Degree or equivalent in a relevant field (e.g., Biotechnology, Bioengineering, Chemistry, Molecular Biology, Biology)
- At least 3-5 years of experience within QA/ GMP regulated environment, preferably at a manufacturing site in Biotechnology / Pharmaceutical Industry
- Good knowledge of GMP regulatory framework and regulatory bodies
- Excellent communication skills and able to work cross-functional, independently but also in a team
- Experience with CMO’s
- Skills in transferring knowledge (trainings), presentation skills for miscellaneous customers (experienced, non-experienced audience)
- Ability to organize and schedule work within a busy office with experience of writing and working to SOP documentation
- Proactive and solution-oriented in a fast-changing environment
- Detail oriented, quick grasp of understanding
- Excellent command of German amp; English (spoken and written) and excellent IT skills
Benefits
- 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, performance-related bonus, lunch vouchers, child care center (Kindergarten), company events
Due to legal reasons we are obliged to disclose the minimum salary for this position, which is 55.000,- gross per year based on full-time employment. However our salaries are market oriented and in line with your qualifications and experience.