Compliance Manager

Sobi - Swedish Orphan Biovitrum AB (publ)

Compliance Manager supporting DACH region to implement Sobi's Global Compliance Program. Collaborating with stakeholders to ensure compliance in healthcare legislation.

Posted 7/25/2026full-timeRemote • 🇩🇪 GermanyMid-LevelSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in developing and implementing compliance programs within the pharmaceutical or life sciences industry, ensuring adherence to local legislation and global standards. Proficient in conducting compliance risk assessments, delivering training, and managing stakeholder relationships effectively.

Highest-signal resume keywords

Compliance Program DevelopmentRisk Assessment and ManagementStakeholder EngagementTraining and Awareness Program DeliveryProject Management

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Compliance Program ImplementationCompliance Risk AssessmentCAPA ManagementInternal Controls DevelopmentRegulatory ComplianceAudit ReadinessMonitoring ActivitiesCompliance InvestigationsPolicy and Procedure DevelopmentData Protection (GDPR)

Soft Skills

Excellent Communication SkillsInfluencing SkillsAnalytical SkillsProblem-Solving SkillsRelationship Building

Industry Keywords

Pharmaceutical IndustryLife SciencesCompliance StandardsFSA CodesLocal LegislationTrade Association PracticesGlobal Compliance InitiativesCross-Functional CollaborationCompliance MonitoringStakeholder Management

About the role

Key responsibilities & impact

Will act as a business partner to support the affiliate to achieve its strategic business objectives with integrity and high ethical standards
Develop, implement, and continuously improve the company’s Compliance Program
Be the first point of contact for DACH affiliate compliance questions related
Act as Affiliate Subject Matter Expert (SME) for Compliance in the Sobi Global Compliance Network
Liaise with the Regional Compliance Office, or with the Global Compliance Department
Identify, assess, and communicate affiliate risks, including compliance Register, remediation action plan.
Provide guidance and partner with business stakeholders on risk management
Be the first point of contact in relation to any correspondence from the FSA codes
Keep abreast with relevant local legislation and trade association practice, take relevant steps to ensure compliance
Where applicable, represent Sobi in local trade association compliance forum
Ensure the affiliate policies, procedures and standards are up to date and aligned with global standards and where necessary CAPA (corrective action & preventive action) are developed and implemented
Develop a local training curriculum, and deliver regular compliance training and awareness
Perform monitoring activities, share the results with business management and Regional/Corporate Compliance Office and ensure mitigation plans are in place and followed through
Support or drive local compliance investigations and assure the right mitigation action of all observed incidents
Ensure prompt communication of potential compliance issues to the GM and Regional Compliance Office
Support and/or drive local implementation of global compliance projects
Provide regular compliance updates to the General Manager and local management team
Ensure audit readiness (e.g., proper record keeping of meeting minutes, decision points, training records, etc.)
Be the first point of contact for affiliate questions and queries related to personal data protection (GDPR)

Requirements

What you’ll need

Bachelor's degree in Law, Business Administration, Life Sciences, Pharmacy, or a related discipline
Minimum of 5 years of compliance experience in the pharmaceutical or life sciences industry
Experience developing, implementing, and maintaining compliance programs, policies, procedures, and internal controls.
Proven experience conducting compliance risk assessments, monitoring, investigations, audits, and CAPA (Corrective and Preventive Action) management.
Experience partnering with cross-functional stakeholders and providing practical, risk-based compliance guidance to business leaders.
Demonstrated ability to design and deliver engaging compliance training and awareness programs.
Experience working with global and regional compliance teams to implement corporate compliance initiatives and manage local regulatory requirements.
Strong project management, analytical, and problem-solving skills, with the ability to manage multiple priorities in a fast-paced environment.
Excellent communication, influencing, and stakeholder management skills, with the ability to build trusted relationships across all levels of the organization.
Excellent written and verbal communication skills in both German and English are required.

Benefits

Comp & perks

Competitive compensation for your work
Emphasis on work/life balance
Collaborative and team-oriented environment
Opportunities for professional growth
Diversity and Inclusion
Making a positive impact to help ultra-rare disease patients who are in need of life saving treatments