Compliance Manager DACH

Sobi

3d•Hybrid

About The Position

The Compliance Manager will act as a business-partner to support the German Affiliate, to achieve its strategic business objectives with integrity and high ethical standards by leading the local implementation and adherence to the Global Sobi Compliance Program. Advising the General Managers and local management to ensure robust governance/compliance processes/systems are in place with well-defined resources & accountabilities and continuously flagging new potential risk areas and proposing mitigation actions. This includes: Compliance with local industry code of practice compliance, Sobi Code of Conduct and relevant Compliance Policies and SOPs Monitoring and risk identification (risk register) and remediation/mitigation action planning Data protection Driving and contributing assurance projects such as monitoring in Germany Implementing and advising on policies, procedures and standards.

Requirements

Graduate degree, ideally in life sciences.
More than 5 years of experience in the pharmaceutical industry, including compliance roles in Germany.
Expert knowledge of regional and local Codes of Practices.
Excellent knowledge of key regulations related to compliance, such as ABAC, Data Protection, TPRM, HCP/HCO engagements, and transparency reporting.
Working knowledge of the healthcare systems in Germany.
Proven track record in compliance roles within the pharmaceutical industry.
Good analytical skills and strategic thinking.
Excellent communication skills on all organizational levels.
Ability to influence in a matrix organization.
Business partnering capabilities.
Capacity to challenge the status quo.
Strong ability to prioritize.
Independent judgment and self-confidence.
Leadership skills to set and drive the compliance agenda.
Demonstrated ability to be trusted and to live Sobi's core values (Care, Ambition, Urgency, Ownership, Partnership) and adhere to codes and policies.

Responsibilities

Act as the primary point of contact for the German Affiliate on compliance-related matters, including Code of Conduct, Anti-Bribery & Anti-Corruption, Healthcare Compliance, Data Privacy, and Third-Party Risk Management.
Serve as the point of contact for local industry codes of practice and lead on compliance-related issues.
Represent Sobi in the FSA compliance forum.
Act as the Affiliate Compliance contact within the Sobi Global and Regional Compliance Network.
Liaise with the Regional Compliance Office and/or the Global Compliance Department as needed.
Ensure prompt communication of potential compliance issues to the General Manager and Regional Compliance Office.
Provide regular compliance updates to the General Manager and local management team.
Embed the Global Compliance Program within the German Affiliate and establish local policies, SOPs, and supportive documents as necessary.
Ensure local policies, procedures, and standards align with local laws and industry Codes of Practices, and implement corrective and preventive actions (CAPA) where needed.
Stay informed about relevant local legislation and trade association practices to ensure compliance.
Drive the local implementation of global and regional compliance projects.
Ensure audit readiness by maintaining proper records of meeting minutes, decision points, and training records.
Perform monitoring activities, share results with business management and the Regional Compliance Office, and ensure mitigation plans are in place and followed through according to the annual Global Monitoring Plan.
Establish an extended local risk-based monitoring plan.
Be responsible for transparency reporting in line with the Global process and local regulations.
Identify, assess, and communicate subsidiary risks, including compliance risks, by maintaining the German risk register and remediation action plan.
Provide guidance and partner with business stakeholders on local compliance risk assessments and risk management.
Act as the point of contact for personal data protection queries, liaising with the regional head of Legal & Compliance or the Sobi group Data Protection Office (DPO) if necessary.
Support the local implementation of the global personal data protection program.
Ensure local vendor assessments are conducted and recorded in accordance with Sobi Policy.
Develop a local training curriculum and deliver regular compliance training and awareness programs to ensure the subsidiary organization is adequately trained.