Director of Quality Operations
vor 2 Wochen
We are a global specialty vaccine company that develops, manufactures, and commercializes prophylactic vaccines for infectious diseases addressing unmet medical needs.
With a strong track record of innovation, we have leveraged our expertise and capabilities to commercialize three vaccines, including the world's first and only chikungunya vaccine, and have rapidly advanced a broad range of vaccine candidates into and through the clinic, including candidates against Lyme disease, Shigella and Zika.
Key Responsibilities
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.
You will lead and manage an integrated quality function (QA Operations, Quality Systems, and Quality Control) and act as the local contact for the oversight and coordination of activities related to site licensing, product licenses and registered processes.
Reporting to the global VP of Quality, you will be part of the Global Quality Leadership Team and have routine interactions with other sites regarding Quality strategy and direction.
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 €68,000.00 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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