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Head of Quality Control
vor 3 Wochen
We are a specialty vaccine company that develops, manufactures, and commercializes prophylactic vaccines for infectious diseases addressing unmet medical needs.
**Responsibilities**
We are currently looking for an experienced and proactive **Head of Quality Control (M/F/d)** on-site in **Vienna**. Reporting directly to the Site Director of Quality, you will be contributing to strategic decisions while **leading the QC team** in a dynamic and purpose-driven environment. Your role will be pivotal in ensuring that all testing processes align with stringent internal quality standards and external regulatory requirements, including compliance with -70 AMG and -9 AMBO 2009. Your Key Responsibilities will include:
- **Lead and develop the local QC team**, including QC Center of Expertise, QC Lab Operations, and Lab Support teams
- Oversee QC testing for release, stability, and raw materials, as well as sample management for QC and Development labs
- Maintain facilities and equipment to ensure functionality and suitability for QC purposes
- Collaborate with stakeholders in Supply Chain and Development to align QC testing with **project timelines**:
- Ensure compliant operations of the in-vivo QC testing in collaboration with the Laboratory Animal Facility
- Manage analytical method transfers and external QC testing activities effectively
- Stay updated on** cGMP guidelines**, pharmacopeia requirements, and scientific advancements in QC testing methods
- Ensure compliance with all internal and external Environment, Health, and Safety regulations for QC staff, facilities, and processes
- Define and manage the **QC budget** (CAPEX and OPEX) to ensure efficient operations and timely delivery of QC results
- Proactively **escalate significant quality issues** related to QC operations to ensure resolution and transparency
**Requirements**:
- Master’s degree (or higher) in **Life Sciences with a minimum of 5 years of relevant industry experience**:
- Extensive **management experience within Quality Control**, Lab operations in GxP regulated life science or pharmaceutical industry
- Proven experience **hosting inspections by FDA** and other global regulatory authorities
- Deep knowledge of **GxP regulations** (GMP, GDP, GCP, GCLP) for EU, US, and other highly regulated markets
- Strong **management and leadership** abilities to inspire and engage multicultural, diverse teams
- Excellent interpersonal communication and assertiveness skills, with the ability to influence and **collaborate across functions**:
- A proactive, innovative, and solution-oriented mindset, able to thrive in a dynamic and fast-changing environment
- High **professional integrity and healthcare ethics**, with in-depth knowledge of quality and regulatory standards
- Ability to make timely, well-balanced decisions that align with compliance and business needs
- Excellent English skills are required, knowledge of German is a plus
**Benefits**
Working with Valneva means being part of a **global biotech company** with a clear vision to make a meaningful **impact in the world**. At Valneva, you can expect a dynamic and **innovative** work environment characterized by an open, appreciative company culture and exciting, **impactful assignments**. Enjoy the benefits of **flat hierarchies**, an international atmosphere, and regular company events that foster **collaboration**and connection.
Additionally, we offer:
- **Work Life Balance**: flexitime & compensation days
- **Financial perks**:Performance-related bonus & Lunch vouchers
- **Lifelong learning**: Unlimited access to LinkedIn Learning & German/English courses for free
- **Health & Wellbeing**: Free access to sports and fitness activities via myClubs
Join us and shape the future of biotechnology
- Due to legal reasons we are obliged to disclose the minimum salary for this position, which is € 90.000 gross per year based on full-time employment. However our salaries are market oriented and in line with your qualifications and experience._
