Job Information
About the Position
Introduction
Werfen
Werfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain. We are a worldwide leader in specialized diagnostics in the areas of Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant. Through our Original Equipment Manufacturing (OEM) business line, we research, develop, and manufacture customized assays and biomaterials. We operate directly in 30 countries, and in more than 100 territories through distributors. Our Headquarters and Technology Centers are located in the US and Europe, and our workforce is more than 7,000 strong.
Our success comes from a specific focus in these rapidly evolving diagnostic areas, our commitment to customers, and our dedication to innovation and quality. We’re passionate about providing healthcare professionals the most valuable and complete solutions to improve hospital efficiency and enhance patient care.
Overview
Job Summary
The Director, Corporate Compliance, North America is responsible for leading the further development, implementation, and continued improvement of the compliance strategy for all Werfen subsidiaries and Technology Centers in the United States and Canada. This role requires strong business partnership and close coordination with the global compliance functions at Werfen’s parent company in Barcelona, Spain. As a result, this position may interact with the Board of Directors for the purpose of advising and making recommendations to the Board about compliance issues. This role additionally has the function of maintaining the effectiveness of the corporate compliance program and ensuring compliance with all applicable rules and regulations. This position will be based at Werfen’s Bedford, Massachusetts office and will report to the Chief Compliance Officer. This role requires a proactive approach to compliance, ensuring that Werfen North America's operations adhere to applicable laws and regulations while fostering an ethical corporate culture.
Responsibilities
Key Accountabilities
- Ensuring that the compliance program effectively prevents and/or detects violations of law, regulations, organizational policies, or the Werfen Code of Ethics, and is regularly assessed to ensure ongoing relevance and responsiveness to emerging risks.
- Ensuring the ongoing effectiveness of the compliance program by recommending appropriate enhancements and advising executive leadership of current and emerging compliance risk areas based on internal findings, external developments, and industry trends.
- Maintaining and operating in the region the Werfen Ethics Channel, an anonymous and accessible reporting system available to all employees and relevant stakeholders.
- Developing, updating, and delivering policies, procedures, educational programs, and training materials tailored to internal and external audiences, with a focus on clarity, relevance, and practical application.
- Ensuring that internal controls are capable of preventing and detecting significant instances or patterns of illegal, unethical, or improper conduct by employees, agents, or other third parties, and that such controls are regularly reviewed for effectiveness.
- Conducting and/or coordinating with other internal and external stakeholders in connection with auditing and monitoring activities, using available tools and data to identify trends and potential risk areas.
- Coordinating, as appropriate, with internal or external legal counsel, and conducting, authorizing, and overseeing investigations of reports that warrant review under the compliance program, ensuring a timely, thorough, and objective process.
- Overseeing follow-up and, as applicable, resolution of investigations and other issues detected by the compliance program, including monitoring corrective action plans.
- Tracking all issues referred to the North American Compliance Department, maintaining appropriate documentation, and escalating matters as needed based on risk and impact.
- Serving as the key advisor and subject matter expert for applicable healthcare regulations, including but not limited to fraud, waste, and abuse laws (e.g., the Anti-Kickback Statute and FCPA), and applicable domestic and international export laws and regulations.
- Overseeing and managing internal administrative compliance processes, including filing Sunshine Act
- reports; obtaining and maintaining export licenses; screening of restricted third parties; conducting third-party due diligence; and maintaining Werfen’s certification to the AdvaMed Code of Ethics.
- Reviewing and approving requests in accordance with Werfen policies, including but not limited to grants, charitable contributions, consulting arrangements, commercial sponsorships, marketing activities, and other interactions with healthcare professionals.
- Liaising with local and global Legal, Data Privacy, and Information Security teams on privacy and cybersecurity matters, including but not limited to HIPAA and GDPR requirements, ensuring a coordinated approach to regulatory compliance.
- Leading, training, and managing direct reports in the North American Compliance Department, providing recurring feedback, setting clear priorities, and fostering professional development.
- Preparing and managing the North American Compliance Department budget to ensure alignment with departmental goals and efficient resource allocation.
- Developing and implementing, with approval from global Werfen Legal and Compliance, an annual review and update to the Werfen North America compliance plan, incorporating insights from monitoring, investigations, and risk assessments.
- Reporting on a regular basis to executive management on matters involving the compliance program, including the preparation of relevant agendas, reports, and metrics to support effective decision-making.
- Performing other duties as assigned.
Networking/Key relationships
- Legal and Compliance Departments (across all locations and groups within Werfen).
- Leadership Team and specific client groups.
- Finance, IT, HR, and Internal Audit.
- Other departments as necessary.
Qualifications
Minimum Knowledge & Experience required for the position:
- University degree in law / compliance / other related field, required.
- For legal degree: Admitted to or qualified for admission to the bar in a jurisdiction within the U.S.
- A minimum of 10 years of experience, ideally with at least 3 years as a Compliance Officer or equivalent leadership position. Advanced leadership experience in a complex, matrixed, multicultural, and multijurisdictional environment.
- Significant knowledge and experience in healthcare regulations including but not limited to HIPAA, FCPA, Anti-Kickback, the Sunshine Act, and U.S. export compliance.
- Full professional proficiency in English and ideally in two other languages.
- Clear, concise, and persuasive writing and presentation skills.
- Strong orientation to deadline and detail.
- Decisive and ability to exercise good judgment under pressure.
- Proactivity and pragmatism.
- Strong emotional intelligence and people skills.
- Flexibility and adaptability to a fast-changing environment.
- Critical and strategic thinking.
- Excellent interpersonal and communication skills.
- Ability to foster teamwork and cooperation internally and with global teams.
- Prioritization, planning, and organization skills without losing focus and maximizingefficiency.
- Robust business acumen, talent, and organizational development skills.
- Ability to develop and maintain productive and congenial working relationships with employees at diverse levels.
- Collaborative and trustworthy leader with ability to share information cross-functionally.
- Excellent facilitator who is experienced in resolving conflicts.
- Unwavering commitment to ethics and integrity.
If you are interested in constantly learning and being challenged on a daily basis we encourage you to submit your resume or CV.
Werfen is an Equal Opportunity employer and is committed to a diverse workplace. Werfen strictly prohibits unlawful discrimination, harassment or retaliation based upon an individual’s race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other protected characteristic as defined by applicable state or federal law. If you have a disability and need an accommodation in relation to the online application process, please contact NAtalentacquisition@werfen.com for assistance.
We operate directly in over 30 countries, and in more than 100 territories through distributors. Annual revenue is approximately $2 billion and more than 7,000 employees around the world comprise our Werfen team.
www.werfen.com
