Compliance Manager DACH

Company Description

Statistics show that women and underrepresented groups tend to apply to jobs only if they meet 100% of the qualifications. Sobi encourages you to change that statistic and apply. Rarely do candidates meet 100% of the qualifications. We look forward to your application!

At Sobi, each person brings their unique talents to work as a team and make a difference. We are dedicated to developing and delivering innovative therapies to improve the lives of people who live with a rare disease. Our edge comes from our team of people and our commitment to patients.

Here at Sobi, our mission and culture get us excited to come to work every day, but here are a few more reasons to join our team:

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

Job Description

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 company’s 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

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.

Additional Information

All Sobi employees need to demonstrate behaviors in line with Sobi's 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 1,900 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, we’re ready to take on the world’s diseases, ailments and adversity. Our people believe they have the power to make a positive impact in others’ lives because that’s exactly what we do here. If you’re 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 can’t 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.