**Company Overview**: Bluestone Pharma is a dynamic and innovative medical probiotics company dedicated to enhancing health and wellness through cutting-edge probiotic solutions. We specialize in the development and distribution of high-quality probiotic products designed to meet the diverse needs of consumers worldwide. Our products are curently sold in approxiumately 40 countries worldwide.
As a Quality Assurance & Regulatory Affairs Manager at Bluestone Pharma, you will play a pivotal role in ensuring the integrity, safety, and compliance of our probiotic product portfolio. Working within a small yet highly dedicated team, you will be responsible for overseeing all aspects of Quality Assurance and Regulatory Affairs, with a focus on maintaining the highest standards across our new product development projects and existing finished product portfolio.
**Key Responsibilities**:
- Lead and manage Quality Assurance functions for our probiotic product portfolio, ensuring adherence to industry regulations and standards.
- Provide expertise and guidance on regulatory compliance requirements, particularly within the European regulatory framework for food supplements.
- Collaborate closely with cross-functional teams tsuch as sales, marketing and operations to ensure adequate QA & RA support is provided for new product development initiatives, country registrartion and customer regulatory support.
- Ensure that any company communicaitons are inline with currentl legislation covering the food supplements/probiotics market.
- Conduct thorough assessments of product quality and safety, implementing effective strategies for continuous improvement. Maintain all documentation up to date.
- Develop and maintain robust Quality Management Systems (QMS) to support compliance efforts and drive operational efficiency.
- Serve as the primary point of contact for regulatory agencies, representing the company's interests and facilitating interactions as needed.
**Qualifications**:
- Bachelor's degree in a relevant scientific discipline; advanced degree preferred.
- Proven experience in Quality Assurance and Regulatory Affairs within the pharmaceutical or healthcare industry.
- Familiarity with QA/QC principles and practices, with a strong understanding of regulatory requirements for food supplements, cosmetics, and/or medical devices.
- Excellent communication skills, with the ability to effectively collaborate with cross-functional teams and external stakeholders.
- Strong organizational skills and attention to detail, with the ability to manage multiple priorities in a fast-paced environment.
- Demonstrated ability to work independently and take initiative, while also thriving in a collaborative team environment.
Tipo de puesto: Jornada completa, Contrato indefinido
Incentivos:
- Flexibilidad horaria
Horario:
- De lunes a viernes
Retribución complementaria:
- Bonus anual
Posibilidad de trasladarse/mudarse:
- 08870 Sitges, Barcelona provincia: Desplazarse al trabajo sin problemas o planificar mudarse antes de comenzar a trabajar (Deseable)
Idioma:
- Inglés (Obligatorio)
Ubicación del trabajo: Teletrabajo híbrido en 08870 Sitges, Barcelona provincia