Compliance Manager DACH

This position can be based in Germany.

Objective for the company:

Will act as a business partner to support the 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 in healthcare compliance (including e.g. transparency data protection and contract management).

Key Responsibilities:

• Develop implement and continuously improve the companys Compliance Program
• To 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
• 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 

Qualifications :

• Bachelors 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.

Additional Information :

All Sobi employees need to demonstrate behaviors in line with Sobis core values: Care Ambition Urgency Ownership and Partnership. Are you ready to be on the Sobi team Come join a culture that empowers every person to be the person that makes a difference for rare disease.

Why Join Us

We are a global company with over 1900 employees in more than 30 countries and are committed to the societies where we operate. With a deeply skilled management team directing our day-to-day wins and a Board with a stellar track record were ready to take on the worlds diseases ailments and adversity. Our people believe they have the power to make a positive impact in others lives because thats exactly what we do here. If youre seeking a career that taps into your talents in a way that makes the world a better healthier place we just may have a job for you.

We know our employees are our most valuable asset and our culture conveys that. We offer a competitive benefits package to support the health and happiness of our staff.

Sobi Culture

At Sobi we refuse to accept the status quo. This is because we have witnessed first-hand the challenges facing those affected by rare diseases and have used this knowledge to shape our business to find new ways of helping them.

As a specialized biopharmaceutical company we are dedicated to rare diseases. And we see this focus as a strength. By effectively turning our research into ground-breaking treatments we help make medicine more accessible and open up more possibilities for patients and more opportunities for those caring for them. This has been our approach since day one but we know we cant change the world of rare diseases on our own. Accomplishing this requires strong partnerships with patients partners and stakeholders across the entire value chain. Together we define how our business can create solutions that serve the needs of those affected by rare diseases while facilitating sustainable growth.

An Equal Opportunity Employer

Sobi is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. All employment decisions at Sobi are based on business needs job requirements and individual qualifications without regard to race color religion or belief national social or ethnic origin sex (including pregnancy) age physical mental or sensory disability HIV Status sexual orientation gender identity protected veterans and/or expression marital civil union or domestic partnership status past or present military service family medical history or genetic information family or parental status or any other status or protected groups by the laws or regulations in the locations where we operate.

Sobi is an affirmative action and equal opportunity employer. Disabled/Veterans. If you are a qualified individual with a disability or a disabled veteran you may request a reasonable accommodation if you are unable or limited in your ability to use or access this website to apply for a vacancy as a result of your disability. You can request reasonable accommodations by sending an email to

Remote Work :

Yes

Employment Type :

Full-time