Executive Director, Ethics & Compliance

Executive Director, Ethics & Compliance Knoa Pharma LLC Stamford, CT Job Details Full-time $251,200 - $351,700 a year 1 day ago Qualifications Bachelor's degree Pharmaceutical company experience Manufacturing company experience Senior leadership Full Job Description Join Knoa Pharma Knoa Pharma is a public health-driven pharmaceutical company dedicated to addressing the opioid crisis. Our focus is on expanding access to lifesaving overdose reversal medicines and affordable treatments for opioid use disorder. Owned by a not-for-profit foundation, everything we do is centered on improving public health, saving lives, supporting recovery, and bringing forward medicines that make a meaningful difference. Knoa Pharma has a robust generics and branded portfolio of medicines in development to address unmet medical needs, and it supports public health initiatives to address the opioid crisis. Its public health-minded purpose enables the company to expand access to lifesaving opioid overdose reversal medicines and affordable treatments for opioid use disorder - at no profit. Position Summary This role is central to demonstrating compliance program effectiveness, continuity, and maturity under DOJ and OIG standards for Knoa Pharma and its subsidiaries. Collaborates to ensure the organization maintains a credible, defensible, and ethically grounded compliance posture in one of the most scrutinized sectors of the pharmaceutical industry. Responsible for enterprise wide leadership and oversight of a DOJ and HHS OIG aligned ethics and compliance program, aligned with the Company's Operating Injunction, with particular emphasis on the heightened regulatory, enforcement, and public health risks associated with opioid and controlled substance manufacturing. Core Responsibilities Co own and operationalize an ethics and compliance program that meets or exceeds DOJ and OIG expectations Assist the CCO in ensuring ongoing compliance with the Company's Operating Injunction, monitorship obligations, and related settlement requirements, including coordination with the independent monitor, timely remediation of findings, and accurate reporting to senior management and the Board. Ensure the program can be demonstrated as effective in practice, consistent with DOJ guidance. Maintain documentation, metrics, and testing sufficient to withstand DOJ, OIG, DEA, and FDA scrutiny. Serve as a business partner, providing ethics and compliance guidance to various business units including but not limited to Commercial, Medical, Technical Operations, and R D. Lead enterprise compliance risk assessments calibrated to DOJ and OIG enforcement priorities. Oversee risk based monitoring and auditing to test whether controls are working effectively. Lead compliance oversight of third parties consistent with DOJ guidance on third party risk management Oversee staff participating in above-outlined functions. Education and Experience Bachelor's degree required; JD strongly preferred. 20+ years of relevant experience, including 15+ years of progressive compliance leadership experience in pharmaceutical or life sciences organizations. CCEP I, CCEP, or equivalent compliance certification strongly preferred. Knowledge, Skills and Abilities Demonstrated experience designing and operating compliance programs aligned with DOJ and HHS OIG expectations. Ability to translate DOJ/OIG guidance into operational practice. Experience utilizing AI enabled tools and advanced analytics to strengthen compliance risk identification, monitoring, and program effectiveness, with appropriate governance, oversight, and documentation consistent with DOJ and OIG expectations. Experience overseeing or advising on compliance risks related to pharmaceutical pricing, including government price reporting programs (e.g., Medicaid Best Price, AMP, 340B), with an understanding of associated DOJ and OIG enforcement priorities. Experience supporting organizations under Corporate Integrity Agreements (CIAs), settlements, monitorships, or enhanced oversight frameworks. Physical and Environmental Requirements This position is primarily office based with occasional travel required (up to 20%), including overnight travel as needed. Supervisory Requirements (if applicable) This position provides leadership and oversight for assigned employees through performance management, goal setting, development planning, and day to day direction in alignment with organizational policies. Additional Information This job description is not intended to be an all inclusive list of duties and responsibilities and may be modified as business needs require. We are an Equal Opportunity Employer. Qualified applicants will receive consideration without regard to: actual or perceived race, sex or gender (including pregnancy, childbirth, lactation and related medical conditions), national origin, ancestry, citizenship status, religion, color, age, creed, sexual orientation, marital status, gender identity or gender expression (including transgender status), protected medical condition as defined by applicable state or local law, genetic information, physical or mental disability, veteran status and military service, or any other characteristic protected by local, state, or federal laws and ordinance. For more information about your rights under Equal Employment Opportunity, visit: EEOC Know Your Rights USERRA Rights Family and Medical Leave Act (FMLA) Employee Polygraph Protection Act (EPPA) E-Verify (English and Spanish) Right to Work (English and Spanish) We strive to make our Career opportunities website accessible to all users. If you need an accommodation to participate in the application or hiring process, please email the Knoa Pharma LLC Talent Acquisition team at . This email is not for general employment inquiries or vendors; rather it is strictly for applicants who require assistance. The Company does not seek or accept unsolicited resumes or CVs from recruitment agencies. We are not responsible for any fees, commission, or any type of payment related to unsolicited resumes or CVs except as required in a written agreement between the Company and the recruitment agency or party requesting payment of a fee. Under certain state law, we may be required to provide a reasonable estimate of the salary range for the jobs covered by this description. Actual salary determinations will take into account factors such as work location, prior education or training and experience, job related knowledge, and demonstrated skills aligned with the Company's internal leveling guidelines and benchmarks. Resumes may be considered in the order they are received.