Compliance Manager

🕒 July 29

🇩🇪 Germany – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

🚔 Compliance

👻 Ghost score 11%

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Sobi - Swedish Orphan Biovitrum AB (publ)

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 1991

🏥 Healthcare

🧬 Biotechnology

💊 Pharmaceuticals

Healthcare • Biotechnology • Pharmaceuticals

Sobi - Swedish Orphan Biovitrum AB (publ) is a global leader in providing innovative treatments for people with rare diseases. Specializing in therapeutic areas such as haematology and immunology, Sobi is committed to improving patient access to medicines for rare and debilitating conditions. With a strong R&D pipeline, the company is actively pursuing new therapies and collaborating globally to transform patient care in areas such as haemophilia and immune thrombocytopenia. Sobi also engages in extensive sustainability and humanitarian aid programs, demonstrating a firm commitment to patient-centric care and societal contributions.

📋 Description

• Compliance Advisor • Point of contact for the German Affiliate in compliance related questions covering Code of Conduct, Anti-Bribery & Anti-Corruption, Healthcare Compliance, Data Privacy, and Third-Party Risk Management • Point of contact in relation to any correspondence from the local industry codes of practice and to lead on any compliance related issues • Represent Sobi in FSA compliance forum • Act as Affiliate Compliance contact in the Sobi Global and Regional Compliance Network • Liaise with the Regional Compliance Office, or with the Global Compliance Department when needed • Ensure prompt communication of potential compliance issues to the GM and Regional Compliance Office • Provide regular compliance updates to the General Manager and local management team • Embed Global Compliance Program in the German Affiliate and establish local policies, SOPs and other supportive documents as needed • Ensure local policies, procedures and standards are in-line and up to date with local laws and industry Code of Practices and where necessary ensure CAPA (corrective action & preventive action) are developed and implemented • Keep abreast with relevant local legislation and trade association practice, and take relevant steps to ensure compliance • Drive local implementation of global and regional compliance projects • Ensure audit readiness (e.g., proper record keeping of meeting minutes, decision points, training records etc.) • Perform monitoring activities, share the results with business management and Regional Compliance Office and ensure mitigation plans are in place and followed through in accordance with the annual Global Monitoring Plan • Identify, assess and communicate subsidiary risks, including compliance, through maintaining the German risk register and remediation action plan • Provide guidance and partner with business stakeholders on local compliance risk assessments and risk management • Point of contact for questions and queries related to personal data protection, liaising with the regional head Legal & Compliance, or if necessary, with the Sobi group Data Protection Office (“DPO”) • Ensure local vendor assessment is conducted and recorded in accordance with Sobi Policy • Develop a local training curriculum, and deliver regular compliance training and awareness ensuring the subsidiary organisation is adequately trained

🎯 Requirements

• Graduate – ideally life sciences degree • >5 years pharmaceutical industry experience including having worked in compliance roles in Germany • Expert knowledge of regional and local Code of Practices • Excellent knowledge of key regulations relating to broader aspects of compliance - e.g., ABAC, Data Protection, TPRM, HCP/HCO engagements and transparency reporting • Working knowledge of the healthcare systems in Germany

🏖️ Benefits

• 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