GxP Compliance Manager

Sobi Group is committed to transforming the standards of care and improving the lives of people living with rare diseases.As a pioneering leader in the field, we strive for an inclusive, sustainable, and flexible workplace that fosters growth and development.The GxP e-Compliance Manager will be responsible for leading and managing Computer System Validation...

We are seeking a highly motivated and detail-oriented QA Specialist to join our team at Recipharm AB. In this role, you will play a crucial part in supporting the implementation of a new quality management system and ensuring the organization's adherence to global quality standards.Your primary responsibilities will include:Managing and leading GxP Training...

We are looking for a highly skilled individual who can drive digital transformation in our Quality Management System (QMS). As the GxP e-Compliance Manager, you will lead the development and implementation of CSV standards, ensuring compliance with global GxP regulations.Key ResponsibilitiesDefine, maintain, and serve as the SPOC for corporate CSV...

As a GxP quality assurance professional, you will be responsible for managing, maintaining, and supporting the eQMS. This includes entering quality-related issues and tracking actions and tasks.Main Tasks & Responsibilities:Manage and lead GxP training, perform SOP training, and lead training in the eQMS.Track KPIs for deviations, change controls, CAPAs,...

We are seeking a results-driven QA Specialist to lead our quality assurance efforts at Recipharm AB. As a key member of our team, you will be responsible for implementing our eQMS, identifying areas for improvement, and ensuring the organization's compliance with global quality standards.Your key responsibilities will include:Developing and delivering...

This QA Specialist role requires a detail-oriented and organised individual with strong analytical and problem-solving skills. You will be responsible for managing and maintaining the eQMS, tracking KPIs, and supporting the QA team in Continuous improvements work. Effective communication and interpersonal skills are essential, along with a strong...

We are seeking a seasoned Quality Assurance professional to lead our GxP system lifecycle management efforts. As the GxP e-Compliance Manager, you will be responsible for overseeing the Computer System Validation (CSV) process and ensuring compliance with GxP regulations.Key ResponsibilitiesOversee GxP system lifecycle management, manage Quality Data...

The System Administrator Manager plays a critical role in ensuring the security and integrity of IT systems at ITBMed. This position involves managing user accounts, troubleshooting access issues, and conducting regular system reviews to ensure compliance with regulatory requirements.Key Responsibilities:User Account Management: Manage user accounts to...

We are seeking an experienced compliance officer to join our team as a QA Specialist. The ideal candidate will have a strong understanding of GxP regulations and experience working in a virtual organisation.Key Responsibilities:Manage and lead GxP training, perform SOP training, and lead training in the eQMS.Track KPIs for deviations, change controls, CAPAs,...

Job DescriptionSobi is a dynamic organization that aims to redefine the standards of care for people living with rare diseases. As a Quality Engineer and GxP e-Compliance Specialist, you will play a pivotal part in ensuring e-compliance and driving digital quality decisions through effective GxP system lifecycle management and quality data stewardship.This...

Head of Quality and ComplianceSobi encourages candidates to apply regardless of their qualifications.We are a global biopharmaceutical company dedicated to rare diseases. Our work redefines care and transforms lives.As a diverse team, we strive for growth towards becoming a global leader, prioritizing patients and innovation.We value an inclusive workplace...

About UsWe are a diverse team of entrepreneurial individuals passionate about growth and innovation. Our mission is to create an inclusive, sustainable, and flexible work environment that fosters growth and development.The role we are hiring for plays a crucial part in achieving this goal by overseeing GxP systems and its data processed in GMP, GDP, GCP, and...

This System Administrator Manager role is critical in ensuring the integrity and security of our IT systems at ITBMed. The successful candidate will oversee user account management, troubleshoot access issues, and conduct regular system reviews to ensure compliance with regulatory requirements.Key Responsibilities:User Account Management: Manage user...

About Sobi GroupWe strive to be at the forefront of innovation and maintain high standards of regulatory compliance.This role will report to our GxP e-Compliance Manager and oversee Quality Data Stewards to ensure adherence to relevant quality and regulatory requirements within the GxP field.Key Responsibilities:Drive the digital Quality roadmap and process...

We strive to create a workplace that empowers our employees to innovate and make a meaningful difference in the field of rare disease treatment.The GxP e-Compliance Manager will be responsible for ensuring the quality and integrity of our systems and processes.Main Responsibilities:eCompliance Oversight: Manage the entire lifecycle of GxP systems, ensuring...

This is a hybrid role that offers the flexibility to work from home or from one of our offices in Sweden (Stockholm HQ) or UK (office located in Cheadle). As a QA Specialist, you will be responsible for managing and maintaining the eQMS, providing support during MHRA/Health Authority inspections, customer audits, and internal audits. Strong analytical and...

The QA Specialist role is crucial to ensuring the quality and integrity of our pharmaceutical products. The successful candidate will have a strong background in quality management and be familiar with GMP regulations.Main Responsibilities:Support the management of QMS processes in a virtual organisation with staff across 7 countries.Manage, maintain, and...

The role of the System Administrator Manager is pivotal in ensuring the integrity, security, and compliance of our IT systems across multiple platforms. This key position involves overseeing user account provisioning, de-provisioning, and modification on various platforms such as Veeva Vault, Trial Interactive eTMF, Simple Trials CTMS, Microsoft 365/Entra...

The ideal candidate will have a strong understanding of GxP regulations, including FDA and EMA requirements. They will possess excellent leadership skills, with experience in managing quality systems and teams.QualificationsBachelor's degree in Life Sciences, Engineering, Computer Science, or related field.Minimum 10 years of experience in the pharmaceutical...

About the JobWe are seeking an individual to facilitate the streamlined integration of new companies and their GxP systems into our e-compliance framework by developing and implementing adaptive GxP processes.Key Responsibilities:Implement Sobi standards and verify compliance through periodic reviews. Ensure adherence to current GxP and Sobi requirements.