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:

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.

Key Responsibilities:

Compliance Advisor

• Point of contact for the German Affiliate in compliance related questions covering Code of Conduct, Anti-Bribery & Anti-Corruption, Healthcare Compliance, Data Privacy, and Third-Party Risk Management
• Point of contact in relation to any correspondence from the local industry codes of practice and to lead on any compliance related issues
• Represent Sobi in FSA compliance forum
• Act as Affiliate Compliance contact in the Sobi Global and Regional Compliance Network
• Liaise with the Regional Compliance Office, or with the Global Compliance Department when needed
• Ensure prompt communication of potential compliance issues to the GM and Regional Compliance Office
• Provide regular compliance updates to the General Manager and local management team

Global Compliance Program

• Embed Global Compliance Program in the German Affiliate and establish local policies, SOPs and other supportive documents as needed
• Ensure local policies, procedures and standards are in-line and up to date with local laws and industry Code of Practices and where necessary ensure CAPA (corrective action & preventive action) are developed and implemented
• Keep abreast with relevant local legislation and trade association practice, and take relevant steps to ensure compliance
• Drive local implementation of global and regional compliance projects
• Ensure audit readiness (e.g., proper record keeping of meeting minutes, decision points, training records etc.)

Monitoring

• Perform monitoring activities, share the results with business management and Regional Compliance Office and ensure mitigation plans are in place and followed through in accordance with the annual Global Monitoring Plan

Establish extended local risk-based monitoring plan.

Transparency Reporting

• Responsible for the transparency reporting in line with Global process as well as local regulations

Risk Assessment

• Identify, assess and communicate subsidiary risks, including compliance, through maintaining the German risk register and remediation action plan
• Provide guidance and partner with business stakeholders on local compliance risk assessments and risk management

Data Privacy

• Point of contact for questions and queries related to personal data protection, liaising with the regional head Legal & Compliance, or if necessary, with the Sobi group Data Protection Office (“DPO”)
• Support local implementation of the global personal data protection program

Third Party Risk Management

• Ensure local vendor assessment is conducted and recorded in accordance with Sobi Policy

Training

• Develop a local training curriculum, and deliver regular compliance training and awareness ensuring the subsidiary organisation is adequately trained

Scope of the role

• Accountable for all aspects of the compliance program for the German Affiliate
• Work closely with other functions such as Legal and Medical in relation to compliance
• Work closely with the Legal Department in relation to compliance and contract management
• Work cross functionally within the German Affiliate to ensure compliance training and processes are in place and effectively implemented
• Work with above country (Europe, International and Corporate) compliance and legal colleagues ensuring implementation of company-wide initiatives relating to all aspects of compliance, including healthcare compliance, risk management, GDPR and HCP/HCO transparency

Qualifications

• Graduate – ideally life sciences degree
• >5 years pharmaceutical industry experience including having worked in compliance roles in Germany
• Expert knowledge of regional and local Code of Practices
• Excellent knowledge of key regulations relating to broader aspects of compliance - e.g., ABAC, Data Protection, TPRM, HCP/HCO engagements and transparency reporting
• Working knowledge of the healthcare systems in Germany
• Proven track record of having undertaken compliance roles within the pharmaceutical industry

Critical competencies

• Good analytical skills and strategic thinking
• Excellent communication skills on all levels within an organization
• 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 – ability to set and drive the compliance agenda
• Being trusted, able to live the Sobi values and adhere to codes and policies

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.

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 talentacquisition@sobi.com.