
Compliance Manager GxP
2 days ago
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 (CSV) and ensuring e-compliance of GxP systems. This role involves overseeing Quality Data Stewards, evaluating and approving high-level quality concepts and documents, and supporting CSV inspections and internal audits.
Main Responsibilities:
- eCompliance Oversight: Oversee GxP system lifecycle management, manage Quality Data Stewards, evaluate and approve high-level quality concepts and documents, and support Computerized System Validation (CSV) inspections and internal audits with follow-up activities and remediation guidance.
- CSV Standards and Implementation: Define, maintain, and serve as the single point of contact (SPOC) for corporate Computerized Systems Compliance (CSV) standards across the company. Enable divisions and business units to implement these global CSV standards.
- Compliance Verification: Implement Sobi CSV standards and verify compliance through periodic reviews, ensuring adherence to current GxP and company requirements.
- Digital Quality Roadmap: Develop and drive the digital Quality roadmap and process quality automation across the GxP arena. Provide strategic leadership in the digital transformation of quality processes.
- Training and Guidance: Provide training and guidance to the team and other stakeholders on CSV standards and eCompliance requirements.
- Regulatory Monitoring: Monitor and analyze global regulatory updates related to GxP and integrate relevant regulatory requirements into the Quality Management System (QMS).
- Continuous Improvement and Leadership: Lead initiatives to enhance GxP compliance processes and engage with stakeholders to ensure alignment in GxP practices. Develop and manage a high-performance team, fostering collaboration and driving continuous improvement and innovation in compliance processes.
We are seeking an individual who demonstrates honesty, transparency, and strong ethical standards in all interactions, ensuring trustworthiness and ethical conduct.
You inspire your team with collaborative leadership, fostering cross-functional cooperation and innovation. As an entrepreneurial company, you adapt quickly to changing environments with resilience.
Key qualifications include:
- Bachelor's degree in Life Sciences, Engineering, Computer Science, or related field.
- Minimum 10 years of experience in the pharmaceutical industry within Quality systems, manufacturing, R&D, or regulatory affairs, with at least 4 years in a leadership role.
- Strong understanding of GxP regulations, including FDA, EMA, and other relevant requirements.
- Proven experience in GxP system lifecycle management, quality data stewardship, and defining/implementing CSV standards.
- Experience in digitalizing QMS, writing procedural documents, and developing digital quality roadmaps.
-
GxP Compliance Manager
7 days ago
Stockholm, Stockholm, Sweden Recipharm AB Full timeWe 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...
-
GxP Compliance Manager
4 days ago
Stockholm, Stockholm, Sweden Sobi group Full timeAbout the RoleThe specialist will oversee GxP systems and its data processed in GMP, GDP, GCP, and GVP field and ensure the lifecycle for appropriate governance and oversight.Key Responsibilities:Ensure eCompliance through comprehensive GxP system lifecycle management, including acting as Business Admin for GxP systems (i.e., Veeva QMS, SQM, and training...
-
GxP System Lifecycle Manager
4 days ago
Stockholm, Stockholm, Sweden Sobi - Swedish Orphan Biovitrum AB (publ) Full timeWe 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...
-
GxP Quality Assurance Professional
7 days ago
Stockholm, Stockholm, Sweden Recipharm Full timeAs 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,...
-
Compliance Quality Manager
7 days ago
Stockholm, Stockholm, Sweden Recipharm AB Full timeWe 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...
-
GxP Training Lead
7 days ago
Stockholm, Stockholm, Sweden Edmond Pharma S.R.L. Full timeThis 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...
-
Quality Assurance Manager
4 days ago
Stockholm, Stockholm, Sweden Sobi - Swedish Orphan Biovitrum AB (publ) Full timeWe 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...
-
Provisioning and Compliance Expert
4 days ago
Stockholm, Stockholm, Sweden ITBMed Full timeThe 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...
-
Compliance Officer
7 days ago
Stockholm, Stockholm, Sweden Recipharm Full timeWe 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,...
-
Digital Quality Assurance Specialist
4 days ago
Stockholm, Stockholm, Sweden Sobi group Full timeJob 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 Compliance
4 days ago
Stockholm, Stockholm, Sweden Sobi group Full timeHead 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...
-
Regulatory Compliance Manager
4 days ago
Stockholm, Stockholm, Sweden Sobi group Full timeAbout 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...
-
Manager of IT Infrastructure
4 days ago
Stockholm, Stockholm, Sweden ITBMed Full timeThis 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...
-
Regulatory Compliance Professional
7 days ago
Stockholm, Stockholm, Sweden Edmond Pharma S.R.L. Full timeThis 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...
-
Validation Specialist
2 days ago
Stockholm, Stockholm, Sweden Sobi group Full timeWe 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...
-
Digital Quality Engineer
4 days ago
Stockholm, Stockholm, Sweden Sobi group Full timeAbout 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...
-
System Administrator Manager
4 days ago
Stockholm, Stockholm, Sweden ITBMed Full timeThe 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...
-
Quality Management Specialist
7 days ago
Stockholm, Stockholm, Sweden Recipharm Full timeThe 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...
-
Compliance Expert
4 days ago
Stockholm, Stockholm, Sweden Sobi - Swedish Orphan Biovitrum AB (publ) Full timeThe 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...
-
Regulatory Affairs Specialist
4 days ago
Stockholm, Stockholm, Sweden Sobi group Full timeAbout 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.