Director of Quality Assurance and Compliance

vor 1 Woche

Wien, Wien, Österreich Valneva Vollzeit

Job Description for Director Quality Operations

We are a specialty vaccine company that develops, manufactures and commercializes prophylactic vaccines for infectious diseases addressing unmet medical needs. Our team is committed to ensuring the highest standards of quality in the development, testing and supply of our vaccines.

As a Director Quality Operations, you will oversee the quality function at our site, including Quality Assurance and Quality Control. Your key responsibilities will include leading and managing an integrated quality function, acting as the local contact for quality and regulatory compliance, and ensuring the site is ready for inspections at all times.

Key Responsibilities

  • Site functional lead for Quality and compliance with applicable pharmaceutical regulatory requirements
  • Recruit, lead and develop local site Quality teams and budgetary control for the function at the site
  • Quality and GMP/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.

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