Global Compliance and Ethics Officer

Job Description

Global Compliance and Ethics Officer

About this opportunity/ Job Description :

The Global Compliance and Ethics Officer (GCE Officer) is responsible for leading the Align's Global Compliance and Ethics program (the GCE program), which operationalizes Align’s commitment to ethical and legally compliant operations.

The GCE Officer will lead and collaborate with the GCE committee to define and implement the strategic objectives for the GCE program, and to provide reasonable assurance to Align’s Board of Directors and senior management that the company has effective controls in place to comply with the law and company policy, and to foster an ethical culture.

Collaborating with senior leaders and working with Regional Compliance and Ethics (RCE) teams, the GCE Officer is responsible for creating a strategic and innovative program that furthers Align’s business goals while identifying and managing Align’s legal risks across the organization. This includes:

• conducting risk assessments;
• identifying and prioritizing risks;
• implementing effective internal controls; including, written policies, procedures, and standards of conduct;
• developing and leading Align’s strategic GCE training program;
• conducting internal monitoring and partnering with Internal Audit as required;
• managing Align’s incident reporting system (including hotline and other channels);
• directing investigations, responding promptly to detected offenses and undertaking appropriate corrective actions; and
• developing and providing regular reports on the effectiveness of Align’s GCE program.

Because there is significant complexity within Align – a matrixed organization driven by its global operations with diversity of technologies and services, customers, and channels – it is imperative that the successful candidate possess strong intellect, agility and sound judgment.

The GCE Officer will be based in Raleigh, NC (preferred), San Jose, California or Zug, Switzerland and report directly to the SVP, Chief Legal & Regulatory Officer who is based in San Jose, CA.

Responsibilities :

• Build and Manage the GCE Team

The GCE Officer will lead and manage the GCE team. The GCE Officer will work to assure the GCE program is adequately resourced and strategically aligned to address the functional and geographic needs of Align, a global, publicly traded medical device company. This includes identifying and mitigating legal risks and advising the company’s Board of Directors, senior leaders, employees and third parties on compliance and ethics matters.

• Foster an Ethical Culture & Values

The GCE Officer is responsible for promoting and enhancing Align’s culture to encourage ethical business conduct and business decisions that comply with applicable laws, company policy, and regulations. The GCE Officer will work collaboratively with Human Resources to define appropriate compliance and ethics goals and objectives for senior leaders as part of their annual development plans, and assure that discipline for both policy violations and for failing to detect and prevent policy violations is appropriate and consistent across the organization.

• Risk Management

The GCE Officer is responsible for assessing Align’s ethical and legal risks and for developing and executing plans to mitigate the risk of non-compliance with laws or non-compliance with Align’s Global Code of Conduct, policies and procedures. The GCE Officer is responsible for developing and conducting regular enterprise risk assessments and processes to identify and mitigate emerging risks and to improve processes. The GCE Officer will oversee and monitor mitigation plans to closure.

• Policies and Procedures

The GCE Officer will be responsible for developing, maintaining and revising GCE policies, procedures and the Global Code of Conduct so that they effectively and efficiently manage legal and ethical risks while supporting Align’s business imperatives. Relying on the results of risk assessments and working with Align’s RCE teams and subject matter experts, the GCE Officer will create or update policies and procedures so the company’s Board of Directors, senior leaders, employees and third parties have standards and guidance for ethical and compliant behavior. The GCE Officer will develop and maintain a systematic process for reviewing and updating policies and procedures as needed based on changing laws and regulations and as Align adapts its strategic business initiatives and plans to comply with these changes.

• Reporting and Monitoring

An innovative and creative compliance program must continuously improve to remain effective. The GCE Officer will develop and operationalize a reporting and monitoring system to provide Align’s Board of Directors and senior leaders with information on the effectiveness of the GCE program and to enable the board and senior leaders to provide strategic guidance and efficiently deploy resources to manage Align's legal risks. The GCE Officer will be responsible for developing a report for the Board of Directors and senior leaders that identifies and prioritizes risks; summarizes significant compliance incidents and investigations; and informs on the effectiveness of the GCE program. The GCE Officer is responsible for modifying the GCE program as needed based on results of any monitoring, auditing, or investigations.

The GCE Officer will manage Align’s GCE reporting systems, including the hotline and other reporting channels. The GCE Officer is responsible for overseeing and conducting internal investigations related to alleged violations of Align's Code of Conduct, policies, procedures or alleged violations of law. The GCE Officer will identify and oversee any remediation required by the findings, including working with the Align Legal team and appropriate leaders to address the findings.

• Training and Communications

The GCE Officer is responsible for developing a strategic global training and communications plan to provide the company’s Board of Directors, senior leaders, employees and third parties a clear understanding of Align’s values and the legal risks it faces as well as the policies and procedures Align has implemented to mitigate these risks, comply with the law, and make ethical decisions. The structure and content of the training and communications plan will consider Align’s international structure, risk assessments and mitigation plans.

Requirements:

The candidate must have a proven ability to:

• make ethical and legal choices;
• comprehend and apply complex laws and regulations to a variety of scenarios;
• collaborate across the organization working with a culturally diverse population;
• promote trust and integrity in a global environment;
• communicate clearly and effectively with all stakeholders;
• provide innovative, practical judgment and counsel;
• proactively identify risks and manage crisis situations;
• develop innovative and creative solutions to problems; and
• work within tight deadlines and prioritize under pressure.

Additionally, the candidate must have:

• In-depth knowledge of applicable global legal and regulatory requirements relating to interactions with health care professionals and health care fraud and abuse laws; and how these requirements apply to the organization’s daily operations.
• In-depth knowledge and experience with developing and implementing compliance and ethics programs for global, publicly traded companies.
• Solid experience integrating compliance and ethics controls into business imperatives, goals, and compliance risks, and using those drivers to identify appropriate compliance strategies to facilitate business objectives while mitigating legal risks.
• Knowledge and experience in managing the risks faced by a global, publicly traded company such as fair trade, anti-bribery and anti-corruption, anti-money laundering, antitrust, and anti-human trafficking.
• In-depth knowledge and understanding of compliance and ethics risk management practices and methodologies, including risk assessment, monitoring/surveillance, and testing activities.
• Strong project management skills, including managing and prioritizing multiple concurrent projects, mapping budget and resource curves, and reporting progress and risks to colleagues and senior management.
• Experience working with functional divisions of a global business such as finance, human resources, marketing, business development, supply chain, engineering and other operational functions.
• Experience working with IT teams to develop technological solutions for compliance and ethics program needs to foster efficient and effective internal controls.
• Strong business and financial acumen, with demonstrated understanding of core business processes (e.g., prior contribution to/participation in strategic planning, product development processes and budgeting).
• Experience in conducting investigations and managing the entire investigations process, including management and tracking of the investigation lifecycle and closeout process.
• Experience executing action plans to remediate issues identified in risk assessments and in investigations.
• Experience developing and implementing programs for effectively managing third party relationships to include due diligence processes, contracting processes, financial and audit controls, and training.
• Ability to act as a clearinghouse for compliance and ethics lessons learned and best practices.
• Experience in developing and maintaining effective lines of communication, including management of hotline and other reporting channels.
• Experience in development, initiation, maintenance, and revision of internal controls, policies and procedures to mitigate identified compliance and ethics risks as well as to detect and prevent illegal, unethical, or improper conduct.
• Experience in monitoring the performance of a compliance and ethics program and related activities on a continuing basis, and taking appropriate steps to improve effectiveness.

Specific Qualifications:

• Bachelor of Science or Bachelor of Arts degree required.
• 10+ years medical device or drug manufacturer compliance professional experience; 8+ years’ experience managing people strongly preferred; 5+ years legal operations experience strongly preferred
• Juris Doctor or Masters of Business Administration preferred.
• Experience with a global, publicly traded company preferred.
• Compliance certifications/credentials preferred.
• Six sigma or equivalent certifications preferred.

Travel/Global Requirements:

• The position requires both domestic and international travel primarily to Align locations in the United States and abroad; 20-50% of time.
• This position also requires a willingness and the ability to work in a global environment, which includes handling calls outside normal working hours on a regular basis.