Senior Director, Compliance and Quality Management

The Company

Welcome to Aetion! Since our debut in 2013, we have grown into one of the country’s leading science-driven technology companies using real-world evidence to provide innovative healthcare solutions.

We achieve this with our Aetion Evidence Platform®, a software platform used to evaluate the safety, effectiveness and value of medications, delivering better outcomes to patients, medical professionals and clients.  We’ve partnered with top biopharma companies and are backed by leading venture capital firms to help further expand our research and product line.

To continue our mission to transform healthcare, we’re assembling a team of talented individuals who know how to work collaboratively and authentically, to innovate and think transformation, not status quo. 

If that’s you, we’d love to hear from you.

Description

The Senior Director, Compliance & Quality Management, will be responsible for the development, implementation, enhancement, and continuous improvement of compliance and quality management programs at Aetion. The role will sit within the Legal & Regulatory department, reporting to the Company’s General Counsel.  In addition, the Senior Director will work collaboratively across the organization and with Aetion leadership to ensure these programs are successful in maintaining high standards of compliance and quality throughout Aetion.  At present, Aetion has a Senior Manager, Compliance & Quality Management, who reports to the Senior Director.

Areas of responsibility will include privacy compliance (e.g., HIPAA, GDPR), financial controls, compliance with contract obligations (including government contracts), FDA regulations, health technology industry standards, Medicare, and information security compliance (working closely with Aetion’s information security team), as well as compliance with general corporate and transactional laws, regulations, and best practices (e.g., FCPA, anti-bribery, OFAC, insider trading, acceptable use, firewall, records retention). 

Responsibilities

The Senior Director’s duties will include, but are not limited to:

• Update and execute a strategic plan to enhance and continuously improve Aetion’s compliance and quality management programs in collaboration with the Legal & Regulatory team
• Lead internal audit function; design, implement, and successfully execute activities to prevent, detect and correct non-conformance 
• Oversee, draft, review, and maintain applicable policies, procedures, codes of conduct, and reports for the compliance and quality management programs
• Maintain and enhance company-wide use of procedures and tools (e.g., Policy Tech or other technology platforms) to host, support and train employees in regard to the company’s compliance and quality management programs, and to ensure proper process around policy development and maintenance 
• Support all departments in day-to-day implementation and adherence to the compliance and quality management programs
• Support new business development with RFIs, RFPs and related requirements to showcase Aetion’s compliance and quality management programs
• Serve as Chair of the internal Compliance Committee
• Be direct supervisor for Senior Manager, Compliance & Quality Management
• Regularly benchmark, assess, and measure the compliance and quality management programs’ effectiveness
• Conduct ongoing training and education in collaboration with other departments
• Drive a company-wide culture of compliance and quality 
• Proactively maintain audit readiness, provide audit responses, track CAPAs and support external audit efforts
• Lead or support client or third party facing audit or requests for information
• Partner closely with the Infosec team on execution and delivery
• Closely work with Aetion’s General Counsel to whom this role reports and its Chief Legal and Regulatory Officer
• Report as needed to Aetion’s CEO and/or Board of Directors on the company’s compliance and quality management programs

Qualifications

Required

• Bachelor’s degree and 12+ years’ experience in a healthcare compliance and quality management role (or equivalent from advanced degree and relevant experience)
• At least 4+ years spent in a management or leadership role in this area 
• Significant experience and skill with compliance and quality management functions: writing policies and guidance documents; supporting various business activities; managing internal and external audits; conducting internal risk assessments; developing recommendations for addressing identified risk
• Based in Aetion’s NY office or remote and willing to travel as necessary for audits, important meetings, etc. 

Preferred

• Advanced degree 
• Experience working in the healthcare information technology industry, including regulatory engagement
• Experience with financial controls and audits
• Experience maintaining compliance with federal government contracting requirements
• Excellent interpersonal, oral and written communication skills
• Meticulous attention to detail and organization
• Strong project management skills
• Self-motivation and willingness to take on responsibility and drive results
• Equally adept at working independently and collaborating with others 
• Ability to work effectively in a fast-paced environment and comfort with ambiguity

About Aetion

• Lead at all levels – Aetion is a diverse workforce of scientific thought leaders and technological innovators coming together with a vision to dramatically improve the Healthcare industry.  Aetion supports and maintains a presence in organizations such as ISPOR, ISPE, ASHP, and HIMSS
• Located in three cities — We have offices located in Midtown Manhattan near Penn Station, Boston's financial district, and Los Angeles. All locations are accessible by various forms of public transportation.
• Social and energetic offices – with a modern layout, and a giant kitchen and eating/social area. We have an open floor plan with an abundance of conference rooms, designed for impromptu collaboration, company gatherings, and industry meetups and events. 
• Great perks – We offer competitive salaries, top-of-the-line benefits, 4% 401(k) match, and unlimited PTO.
• Awards – Aetion is the recipient of numerous prestigious awards: 
• Built In Boston and Built In New York 2022 Best Places to Work
• Parity.org’s 2022 Best Companies for Women to Advance 
• NYC Health Business Leaders’s 2022 Digital Health 100

Aetion is an Equal Opportunity Employer. Aetion is committed to being an employer of choice, not just a good place to work, but a great and inclusive place to work. To that end, we strive to recruit and maintain a workforce that meaningfully represents the diverse and culturally rich communities that we serve. Qualified applicants will receive consideration for employment without regard to their race, color, religion, national origin, sex, sexual orientation, gender identity, protected veteran status or disabled status or, genetic information.