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Director Quality Operations
vor 3 Monaten
We are a specialty vaccine company that develops, manufactures, and commercializes prophylactic vaccines for infectious diseases addressing unmet medical needs.
We have leveraged our expertise and capabilities both to commercialize three vaccines, including the world’s first and only chikungunya vaccine, and to rapidly advance a broad range of vaccine candidates into and through the clinic, including candidates against Lyme disease, Shigella and Zika.
Responsibilities
We are currently looking for a Director Quality Operations (m/f/d) to join our team. In this role you will interact with diverse relationships (internal/external) across all functions required to routinely ensure/oversee quality in the development/testing/supply of the commercial vaccines and the manufacture of vaccines/materials used in clinical trials.
To ensure that all operations on site are being conducted according to all internal and external quality and regulatory compliance requirements by leading and managing an integrated quality function (i.e. QA Operations, Quality Systems, and Quality Control) as well as acting as the local contact for the oversight and coordination of activities related to Vienna site licensing, product licenses and registered processes.
Reporting to the global VP of Quality, this position is part of the Global Quality Leadership Team and has routine interactions with other sites regarding Quality strategy and direction. Your Key Responsibilities will be the following:
- Site functional lead for Quality and compliance with applicable pharmaceutical regulatory requirements, Local line management responsibilities for Quality Assurance and Quality Control
- Recruit, lead and develop local site Quality teams and budgetary control for the function at the site
- Quality and GMDP/GCLP oversight of the site, including the performance of CMOs, Suppliers, Consultants and service providers
- Responsible for the local QMS and implementation of (and adherence to) the Global QMS
- Ensure the site is ready for GMDP inspection at all times
- Ensure Regulatory Compliance by supporting the Regulatory Affairs department where appropriate and ensuring that all licensing conditions, regulatory authority guidance and expectations are respected
- Assist in setting Valneva’s GxP quality standards, as part of the Global Quality Leadership Team
- Lead the site’s Quality escalation to senior management (primarily the Site Head and the Vice President Global Quality)
- Develop, collate and report key quality metrics and use these to drive a culture of continuous process improvement and compliance, fostering the development of Valneva Livingston’s quality culture
Requirements
- Degree in the Life Sciences, with not less than 8-10 years’ work experience in the lifescience or pharmaceutical industry, ideally including vaccines
- Extensive (a minimum of 5 years’) senior management experience within Quality Assurance, Quality Systems and Quality Control in GxP regulated lifescience or pharmaceutical industry
- Experience as a QP/RP in EU is desirable. Eligibility to become an RP and/or QP is a requirement
- Profound knowledge of relevant GxP (GMP, GDP, GCP, GCLP) legislation for EU, US and other global highly-regulated markets
- Accustomed to work in an international environment with multilingual teams composed of various cultures is desirable
- Strong management and leadership skills with the ability to motivate and engage
- High standards of professional/healthcare ethics and integrity with an extensive knowledge of all applicable quality and regulatory related standards, regulations and internal procedures
- Open-minded and innovative/creative team-player
- Good interpersonal communication and influencing/assertiveness skills
- Proactive, solution-oriented and able to react flexibly in a fast-changing environment
- Able to make timely, correct and compliant decisions that, as applicable, are aligned with business needs
- Ability to analyze information in a structured, rational and scientific/balanced way
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, compensation days, performance-related bonus, lunch vouchers, child care center (“Kindergarten”), company events, myClubs, LinkedIn Learning etc.
Due to legal reasons we are obliged to disclose the minimum salary for this position, which is € 110.000,00 gross per year based on full-time employment. However our salaries are market oriented and in line with your qualifications and experience.
