Compliance Director

Dompé is an Italian bio-pharmaceutical company that focuses on innovation, where a long tradition in the field of personal wellness goes hand-in-hand with a commitment to research and development to meet unsatisfied therapeutic needs. 

Established in 1940 in Milan, Dompé has an industrial and biotech research hub in L’Aquila, in addition to branches in Europe (Barcelona, Berlin, Paris and Tirana). The company has approximately 900 employees. The US headquarters of Dompé are based in Boston (R&D) and in the San Francisco Bay Area (Commercial Operations). 

Job Summary:

Deputy to U.S. Compliance Officer:

• Strategy: Collaborate closely with the U.S. Compliance Officer to achieve compliance goals through effective leadership, management, strategic direction, and budget and business planning.
• Management: Manage and direct the U.S. Compliance team and partner with global Compliance colleagues to maintain and further develop a strong culture of ethics and compliance throughout the organization.  Escalate issues as needed to the U.S. Compliance Officer.
• Reporting: Provide regular updates and reports to the U.S. Compliance Officer and executive management on the operation and progress of compliance efforts and initiatives, investigation outcomes, project status updates, as well as potential risks and proposed solutions.
• Representation: Represent U.S. Compliance in various governance bodies, including but not limited to the Global Policy Task Force, the Patient Assistance Program Steering Committee, the Grant Review Committee, and any working groups formed to evaluate business development transactions

Overall Compliance Program Support:

•  Implement and evolve the Company’s compliance program in the U.S. and globally, to the extent applicable, to ensure consistency with Dompé’s values and compliance with applicable local and global requirements.
• Develop trusted relationships with employees across the Company to promote a Speak Up culture.

Cross-Functional Business Partner:

• Provide solutions-oriented compliance advice/support to the business on compliance matters, to advance the proactive identification, assessment, and mitigation of compliance related risks.
• Collaborate cross-functionally with departments such as Legal, Commercial, Medical, HR, ITC, Finance, and business colleagues to, as needed, (i) advise, coordinate and/or facilitate implementation of policies, procedures or practices related to compliance, (ii) identify emerging risks and (iii) assist in implementation of identified remediation, as applicable.

Compliance Risk Assessment:

• Develop and execute the annual U.S. compliance risk assessment; assist in and oversee the implementation of corrective action plans, as necessary.
• Partner with global Compliance, Internal Audit, and the Enterprise Risk Management Lead to develop and update a holistic Company risk profile.

Investigations Support:

• Conduct and support investigations into allegations of misconduct and/or implement programmatic remediation, as required, including directing and working with outside counsel, as necessary. 
• Identify patterns of activity that require remediation and process improvements

Policies:

• Develop, implement, and/or update local and global policies and procedures, to ensure compliance with applicable local laws, regulations and industry codes and alignment with global policies.
• Continually assess identified issues from compliance investigations and other data to identify opportunities to improve U.S. and global policies and develop plans to address high priority opportunities.

Training and Communications:

• Ensure the existence of an effective training and communications program to ensure understanding of employee responsibilities and compliance, as well as related policies and procedures, including as applicable in-person sessions, campaigns, and others as applicable per Dompé U.S.’s needs.

Continuing Education Informs Program Evolution:

• Monitor and maintain a current understanding of regulatory and compliance trends and changes in local laws, applicable industry codes and/or guidelines relevant to Dompé’s operations in the U.S. to inform the continuous improvement of the compliance program.

Other:

• Additional responsibilities as may be assigned from time to time in the Company’s discretion

Experience and Education:

• Bachelor’s Degree required; 
• Minimum of 8 years of professional experience in ethics, compliance and/or legal in an organization subject to biopharmaceutical or other relevant healthcare compliance laws and regulations.
• Strong understanding of U.S. state and federal healthcare laws, regulations, and industry codes required.
• Demonstrated ability to work collaboratively and cross-functionally in a team environment with a wide variety of company personnel, across the broader organization on a broad range of matters, in a multi-cultural environment.
• Ability to manage multiple projects, deadlines, and priorities simultaneously and to flourish in a fast-paced and high energy environment.
• Able and eager to work autonomously and to manage and oversee discrete areas of responsibility with little direct supervision, with proper understanding of escalation principles.
• Excellent organization, communication (verbal and written – fluency in English required, any other additional language a plus) and prioritization skills, including the ability to communicate effectively in a global environment, to integrate compliance and business considerations, and to provide solutions-oriented advice regarding compliance risks.
• Some travel is required.

BENEFITS OF JOINING OUR TEAM: 

• Comprehensive medical benefits: we value access to healthcare for our patients as well as our employees
• Generous vacation / holiday time off: we care about our employees and encourage a balanced lifestyle
• Competitive 401(K) matching
• Bay Area office with great views, located in vibrant downtown San Mateo and within walking distance to restaurants, coffee shops, and the Cal Train
• A super cool team who’s excited to transform lives through innovative therapies

$210,000 - $250,000 a year 

At Dompe, we offer an attractive compensation package to our team members. Any offer would include a competitive base salary (estimate shared above), incentive bonus, and benefits package customary to the position. Actual individual pay is determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. 

We believe that the unique contributions of all employees create our success. To ensure that our products and culture continue to incorporate everyone’s perspectives and experience, we never discriminate based on race, religion, national origin, gender identity or expression, sexual orientation, age, or marital, veteran, or disability status. All your information will be kept confidential according to EEO guidelines