Compliance Manager

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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

• 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

• 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

• 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