Compliance Manager DACH

Sobi

1d • Hybrid

About The Position

This position can be based in Germany. The objective for the company is to act as a business partner to support the affiliate in achieving its strategic business objectives with integrity and high ethical standards by leading the local implementation and adherence to the Global Sobi Compliance Program in healthcare compliance (including e.g. transparency, data protection and contract management).

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.

Responsibilities

• Develop, implement, and continuously improve the company’s Compliance Program
• Be the first point of contact for DACH affiliate compliance questions
• 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
• In collaboration with the Global Compliance Department, 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), liaising with the regional head Legal & Compliance, or if necessary, with the Sobi group Data Protection Officer (“DPO”)
• Support local implementation of the global personal data protection program
• Responsible for affiliate transparency reporting in line with Global process as well as local regulations

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
• competitive benefits package

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level