Manager QA Operations
Vor 4 Tagen
We are a specialty vaccine company that develops, manufactures, and commercializes prophylactic vaccines for infectious diseases addressing unmet medical needs.
**Responsibilities**
As **Manager QA Operations**, you will play a key role in ensuring the smooth and compliant execution of our Quality Management System (QMS) at the **Vienna** site. You will l**ead a motivated team** and help **maintain the highest standards of quality and regulatory compliance** (cGxP), while fostering a culture of continuous improvement and collaboration. Your key responsibilities will be:
- Lead and inspire the QA Operations team to ensure high performance, motivation, and stability
- Oversee and continuously **improve day-to-day QA operations**, including batch record review, quality event handling, and CMO oversight — ensuring timely and compliant execution
- Ensure the effective implementation and **maintenance of the local QMS** in alignment with global standards and applicable GxP regulations (GMP/GDP)
- Act as lead host during regulatory and customer inspections, representing Valneva with professionalism and confidence
- Collaborate closely with the Head of QA and other key stakeholders to drive continuous improvement and ensure lean, best-practice quality operations
- **Function as lead auditor** for both internal and external audits
- Ensure full cGxP compliance in all QA operational and QMS-related processes
- Promote lean and efficient quality operations aligned with industry best practices
- Drive proactive stakeholder engagement across departments
- **Provide support to the Director QA Operations on strategic initiatives**, projects, and quality improvements as needed
- Collaborate closely with QA Systems, QA Center of Excellence (CoE), and other cross-functional teams
**Requirements**:
- Academic **degree in Natural Sciences or equivalent** (e.g. BSc, MSc, Mag., CTA/HTL, MTA) and significant experience in the **pharmaceutical or life sciences industry** required
- **Several years** of hands-on experience in Quality Assurance and/or Quality Control in a **GxP-regulated environment**:
- Deep understanding of EU, US, and Canadian GxP regulations (GMP, GDP, GCP, GCLP)
- Proven experience in **leading internal and external audits**, and hosting health authority inspections
- Strong knowledge of quality systems and **QMS processes**, including SOP development and continuous improvement
- Demonstrated **ability to lead and develop teams**, with strong organizational and project management skills
- Proactive, solution-oriented mindset with a **high sense of accountability and integrity**:
- Excellent communication, collaboration, and stakeholder management skills - comfortable working cross-functionally and internationally
- Fluent in English (written and spoken), German is an asset
**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 & Office Massages
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 € 60.000 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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