Sobi - Swedish Orphan Biovitrum AB (publ)

Product Manager

• Subject matter expert (SME) and process owner for Drug Product (DP) manufacturing of a small molecule used in non-sterile dosage forms.
• Oversee all technical drug product manufacturing aspects (fully under GMP) for a small molecule manufactured at an external manufacturer.
• Lead the technical workstreams of product transfers from development to commercial site and between commercial sites, scale-up activities, process validations and oversees manufacturing of Drug product with a small molecule at external manufacturers for projects in clinical and commercial phase.
• Lead internal activities related to external manufacturing such as process change assessments, major/critical deviations, risk assessments and CAPAs
• Review and supervise set up, execution and documentation of DP related technical studies (CMC development and commercial operations), process and equipment qualifications and validations.
• Write and review applicable sections in registration files, variations and market expansion
• Issue, review and approve applicable internal and external SOP's and external manufacturer manufacturing instructions.
• Contribute during set up of new analytical specifications and stability programs and review changes thereof
• Support in sourcing evaluation of new Drug product small molecules, hard-gelatine capsule based alternative contract manufacturers and participation in developing supply and quality agreements.

Manufacturing Science and Technology Drug Product Lead

Program Manager

• Lead an international cross-functional technical CMC team
• Project manage all key CMC deliverables
• Assure integrated program plans are in place
• Coordinate the identification and mitigation of program issues and risks
• Build holistic, scientifically sound and relevant scenarios as decision proposal
• Coordinate the review process of technical documents
• Responsible for program budget and long-term projections

Technical Operations Program Manager – Associate Director

• Lead an international cross-functional technical CMC team
• Project manage all key CMC deliverables
• Assure integrated program plans are in place including cross-functional interdependencies
• Coordinate the identification and mitigation of program issues and risks
• Build holistic, scientifically sound and relevant scenarios as decision proposal at all governance levels
• Coordinate the review process of technical documents
• Responsible for program budget and long-term projections
• Follow the invoices and confirm the corresponding work execution to the budget owner

• Lead an international cross-functional technical CMC team
• Coordinate team interactions ensuring team meetings have structure and purpose
• Document clear decisions/actions and communicate them to team members and stakeholders
• Assure integrated program plans are in place including cross-functional interdependencies
• Facilitate the setting and tracking of program objectives and priorities
• Coordinate the identification and mitigation of program issues and risks
• Build holistic, scientifically sound and relevant scenarios as decision proposals at all governance levels
• Coordinate the review process of technical documents
• Coordinate the preparation for governance and executive management program presentations
• Responsible for program budget and long-term projections
• Follow the invoices and confirm the corresponding work execution to the budget owner

• Subject matter expert (SME) and process owner for Drug Product (DP) manufacturing of a small molecule used in non-sterile dosage forms
• Oversee all technical drug product manufacturing aspects (fully under GMP) for a small molecule manufactured at an external manufacturer
• Lead the technical workstreams of product transfers from development to commercial site and between commercial sites, scale-up activities, process validations and oversees manufacturing of Drug product with a small molecule at external manufacturers for projects in clinical and commercial phase
• Lead internal activities related to external manufacturing such as process change assessments, major/critical deviations, risk assessments and CAPAs
• Review and supervise set up, execution and documentation of DP related technical studies (CMC development and commercial operations), process and equipment qualifications and validations
• Write and review applicable sections in registration files, variations and market expansion
• Issue, review and approve applicable internal and external SOP's and external manufacturer manufacturing instructions
• Contribute during set up of new analytical specifications and stability programs and review changes thereof
• Support in sourcing evaluation of new Drug product small molecules, hard-gelatine capsule based alternative contract manufacturers and participation in developing supply and quality agreements
• Be aware of external manufacturing technology advancements, understand and introduce new technologies and how they may be applicable to process innovation, cost or yield improvement
• Other job related tasks

Manufacturing, Science and Technology Lead

Manager

• Join Sobi’s mission to improve the lives of people with rare diseases by ensuring the highest standards of product quality and patient safety
• Act as the primary point of contact for external manufacturing partners
• Ensure compliance with GMP/GDP requirements
• Support release products to Markets
• Guide defining & monitoring remediation plans to address quality issues
• Ensure a good collaboration is maintained within the Global Quality Operations and cross-functionally

External Quality Operation Manager – GMP

• Subject matter expert (SME) and process owner for Drug Product (DP) manufacturing of a small molecule used in non-sterile dosage forms.
• Oversee all technical drug product manufacturing aspects (fully under GMP) for a small molecule manufactured at an external manufacturer.
• Lead the technical workstreams of product transfers from development to commercial site and between commercial sites, scale-up activities, process validations and oversees manufacturing of Drug product with a small molecule at external manufacturers for projects in clinical and commercial phase.
• Lead internal activities related to external manufacturing such as process change assessments, major/critical deviations, risk assessments and CAPAs.
• Review and supervise set up, execution and documentation of DP related technical studies (CMC development and commercial operations), process and equipment qualifications and validations.
• Write and review applicable sections in registration files, variations and market expansion.
• Issue, review and approve applicable internal and external SOP's and external manufacturer manufacturing instructions.
• Contribute during set up of new analytical specifications and stability programs and review changes thereof.
• Support in sourcing evaluation of new Drug product small molecules, hard-gelatine capsule based alternative contract manufacturers and participation in developing supply and quality agreements.
• Be aware of external manufacturing technology advancements, understand and introduce new technologies and how they may be applicable to process innovation, cost or yield improvement.

• Act as the global System Administrator for the Veeva Vault CRM platform
• Configure and evolve core Vault CRM modules (e.g. Account Management, Call Reporting, CLM, Events Management, Campaign Manager, Approved Email, Surveys, Medical Inquiry, Cycle Plans, Event Meetings)
• Translate complex business needs into scalable, compliant system solutions
• Manage roles, permissions, security, and data governance
• Provide operational support, troubleshooting, and user enablement
• Develop and maintain technical documentation, configuration records, and training materials
• Lead integrations with downstream data platforms and external digital ecosystems
• Collaborate with Commercial, Medical Affairs, Compliance, Regulatory, and Data teams to streamline processes and improve field efficiency
• Identify and implement innovative solutions—including generative AI and predictive analytics—to enhance HCP engagement and field productivity.
• Partner with Data Science teams on proof-of-concept initiatives such as AI-powered call note summarization, smart segmentation, and next-best-action recommendations.

Commercial Cloud Manager

QA Engineer

• Ensuring quality oversight and quality assurance and quality by design activities related to GCP/GCLP area
• Guide and support from a quality perspective the GCP/GCLP and GPP related activities within Sobi
• Support the collection of the data needed for Audit program risk assessment
• Ensure qualification of global and local ESP, as applicable, in GCP regulated area per Sobi procedures
• Ensure GCP Audits management excellence of the end to end audit management process and overview of the assigned audits
• Assess and approve from quality perspective the GCP deviations (global and local, as applicable), GCP related CAPAs.

QA Manager, GCP

Operations

• Veeva Ecosystem Ownership (CRM & Network)
• System Administration: Serve as the primary owner for Veeva CRM and Veeva Network.
• Manage configuration, data stewardship, and the integration between these platforms.
• MDM & Data Integrity: Oversee the Data Change Request (DCR) process within Veeva Network to ensure field teams have accurate customer data.
• Serve as the primary liaison to the Enterprise Data team (Informatica MDM owners) to resolve data discrepancies and ensure seamless integration.
• Territory & Roster Management: Manage the operational execution of territory alignments.
• Responsible for bulk data loading of territory assignments (ATL), roster changes, and target lists directly into Veeva CRM.
• Operational Health: Maintain system integrity through regular audits of user access, security profiles, and data segmentation.
• Business Analysis & Solution Delivery Requirements Gathering: Partner with Sales Leadership, Marketing, and Medical to document business requirements for new field strategies.
• Solution Design: Translate business needs into technical user stories and functional specifications.
• Identify opportunities to reduce 'clicks' and improve field efficiency.
• Release Management: Prioritize and implement system enhancements.
• Lead the end-to-end release cycle, including sandbox configuration, UAT coordination, and production deployment.
• Launch Readiness: Lead the technical workstream for new product launches, ensuring call plans, targeting, and content are configured and validated prior to Day Field Enablement & User Support Adoption & Training: Create and maintain training materials, job aids, and release notes to drive system adoption.
• Tier 2/3 Support: Serve as the escalation point for complex technical issues that cannot be resolved by the help desk, troubleshooting data visibility or sync errors.
• Digital Asset Management: Ensure the availability and proper functional deployment of digital assets (CLM, Approved Email) within the CRM.

Senior Manager, Field Operations – Commercial Systems Operations

• Own the end-to-end lifecycle of Pharmacovigilance Agreements (PVAs), including development, execution, maintenance, and termination where applicable, along with all associated deliverables
• Contribute to strategy setting in collaboration with line management as required, ensuring compliant and efficient solutions for all parties
• Collaborate with global functions to provide expert advice and support on commercial agreements, named patient use supplies, and other managed access programs, ensuring optimal and compliant pharmacovigilance obligations are embedded
• Work closely with internal Patient Safety functions and cross-functional Sobi departments to ensure full alignment with Global Pharmacovigilance (GPV) agreements
• Oversee and manage pharmacovigilance collaborations and alliances with external business partners, including co-marketing, co-development, distributor partners, and healthcare organizations
• Lead the negotiation and establishment of pharmacovigilance agreements, clearly defining roles, responsibilities, and conditions to enable seamless collaboration
• Partner efficiently with the Sobi Global Pharmacovigilance group and other key stakeholders to ensure PVAs are effectively implemented, maintained, and monitored
• Provide subject matter expertise on current and evolving pharmacovigilance regulations and guidelines, both internally and externally
• Develop and implement a comprehensive pharmacovigilance collaboration strategy focused on effective communication, data exchange, compliance, and risk management
• Represent the PVA function in internal and external meetings, providing updates, insights, and guidance on pharmacovigilance collaborations and activities
• Support pharmacovigilance audits and inspections related to collaborations, including contribution to corrective and preventive action (CAPA) plans
• Train and educate internal teams on pharmacovigilance standards, procedures, and collaboration requirements
• Continuously identify opportunities for process improvement, efficiency gains, and risk mitigation across pharmacovigilance collaborations
• Act as deputy for the Global PV Licensing Director as required

Senior Pharmacovigilance Licensing Manager

Account Manager

• Drive strategic engagement and long-term partnerships across priority hospital and regional accounts
• Lead the development and execution of strategic account plans for key nephrology centers and regional stakeholders
• Build trusted, long-term partnerships with KOLs, clinicians, payers, and decision-makers
• Drive cross-functional collaboration across medical, market access, and marketing to deliver aligned customer solutions
• Capture, analyze, and share actionable insights to inform brand strategy, market access, and lifecycle management
• Support launch readiness, omnichannel initiatives, and local adaptation of marketing materials
• Navigate local market access and HTE frameworks, translating insights into value-based stakeholder discussions
• Analyze market trends, competitor activity, and treatment pathways to identify growth opportunities
• Ensure high standards of compliance, ethics, and CRM reporting
• Represent Sobi at national congresses and lead impactful stakeholder engagements

Key Account Manager

Medical Director

• Own the end-to-end medical strategy – Lead pre-launch, launch, and lifecycle planning across FCS and sHTG, ensuring scientific coherence and impact.
• Drive evidence generation & data strategy – Define and evolve the Medical Affairs Plan, overseeing RWE, ISS, NIS, HEOR, and disease-understanding initiatives with scientific rigor and compliance.
• Lead scientific engagement – Shape KOL strategy, sponsor advisory boards and congress activities, and act as senior medical expert internally and externally.
• Ensure medical content excellence – Oversee scientific narrative, publications planning, and medical materials with high standards of accuracy and clarity.
• Strengthen cross-functional partnership – Represent Medical strategically across Commercial, Market Access, Regulatory, Clinical Development, and Patient Advocacy teams.
• Champion Medical Excellence & governance – Implement planning standards, KPI tracking, compliance oversight, and continuous improvement initiatives.
• Drive launch readiness & lifecycle expansion – Ensure medical leadership during launch and support future indication development.

Associate Medical Director

• Oversee the ISS review and approval process, including proposal validation, coordination of reviews, and communication of decisions to stakeholders.
• Manage the MAP/PTA review and approval process, including coordination of case reviews, decision documentation, and communication with relevant parties.
• Serve as the global point of contact for ISS and MAP management for designated products, working with cross-functional internal and external stakeholders.
• Maintain comprehensive databases for ISS and MAP/PTA, tracking proposals, studies, and decisions with relevant documentation.
• Facilitate contract development and negotiation between sponsors/requestors and Sobi, collaborating with legal, MPL, and other functions as required.
• Support supply chain set-up in conjunction with Affiliate teams and Sobi Supply Chain for both ISS and MAP/PTA programs
• Provide regular status updates on ISS and MAP/PTA programs to responsible teams and leadership.
• Monitor milestone payments and report ISS budget to budget owners.
• Coordinate with vendors on the set-up and management of MAP and PTA programs as needed.

Manufacturing Science and Technology Drug Product Lead

Technical Operations Program Manager – Associate Director

Technical Operations Program Manager – Associate Director

Technical Operations Program Manager – Associate Director

Manufacturing, Science and Technology Lead

External Quality Operation Manager – GMP

Manufacturing, Science and Technology Lead

Commercial Cloud Manager

QA Manager, GCP

Commercial Cloud Manager

Senior Manager, Field Operations – Commercial Systems Operations

Senior Pharmacovigilance Licensing Manager

Key Account Manager

Associate Medical Director

Medical Excellence Manager, ISS, MAP