**Job Description**:
Our Animal Health division is a global leader in veterinary medicine and digital solutions dedicated to the health and well-being of animals and the people who care for them. We are a global team of professionals working together to make a positive difference in animal health and well-being and supporting a safe food supply. Through our commitment to the Science of Healthier Animals®, we offer one of our industry’s most innovative portfolio of pharmaceuticals, vaccines and digital health management solutions including traceability and monitoring products that serve to prevent, treat, and control diseases across all major farm and companion animal species.Our Manufacturing Operations teams are the people that make our products. We work in the manufacturing plants with a “Safety First, Quality Always” mindset striving for continuous improvement. We work in the local plant connected to our global manufacturing network to ensure the highest quality of raw materials, intermediates and finished products.For our new production facility in **Krems a.D. Donau** we are looking for an experienced**Head of Quality Systems & Compliance (M/F/d)**Full-time, as soon as possiblewith several years of experience within the Pharmaceutical Industry. You will lead the Quality Systems organization and report directly to the Head of Quality Krems.The mission of the position is to develop and lead the Quality Systems and maintain the regulatory compliance for the manufacturing of medicinal products at the company in Krems. Another goal is to drive the digitalization initiatives and ensure the validation of computerized systems and data integrity.**Key attributes of the position**:
- Lead the Quality Systems organization and maintain the regulatory compliance for the manufacturing of medicinal products at the local site- Managing the team within Quality Systems- Drive the digitalization initiatives and support the quality unit in the digitalization pathway - ensure the validation of computerized systems and data integrity at the site- System Owner for the quality systems for all Quality Systems, guide and develop the sub-system Owners- Implement and maintain the relevant laws, regulations, guidelines, and the company Quality Manual as well as the SDLC rules- Provide oversight on computerized systems, automated systems as well as equipment, provide advice, review and approve qualification and validation documents- Be the primary contact for Global Regulatory Affairs for regulatory activities, partner and support the Global and Regional Quality Functions- Writing, review and approval of GMP documents at the site**Qualification and Experience**:
- Degree in Chemistry, Biology, Biotechnology, Pharma or an equivalent natural science- At least 10 years of experience in a Pharmaceutical Company- Practical experience in Quality Systems in the industry- Experience or knowledge in CSV and Data Integrity- Experienced people manager- Experience or knowledge in change management, deviations, and CAPAs management- Energetic and enthusiastic team player with innovative mindset, strategic, analytical and problem-solving skills- Excellent communication, interpersonal and organizational skills- Good text writer, accuracy, versatility, adherence to delivery dates and love for details- Flexibility, positive attitude, cooperativeness, and friendliness- Fluency in written and spoken German and English**We offer**:
- Unique possibility to participate in the establishment of a state-of-the-art production site- Diversified responsibilities in an international surrounding- Collaboration with professional and highly motivated team members- Participation in a respectful and positive working climate- Attractive career opportunities as well as good training and development possibilities**Who we are**We are known as Merck & Co., Inc., Rahway, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.**What we look for**Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us—and start making your impact today.We are proud to be a company that embraces the value of bringing diverse, talented, and commi