Director, Quality Assurance - GxP (GCP) Remote
Axsome Therapeutics IncSalary not specified
- Full Time
- Senior (5 to 8 years)
Not SpecifiedCompensation
Mid-level (3 to 4 years), Senior (5 to 8 years)Experience Level
Full TimeJob Type
UnknownVisa
Healthcare, ComplianceIndustries
Requirements
Candidates should possess 5-7 years of experience in compliance, audit, or monitoring roles within an in-house associated group such as Quality Assurance, Compliance, or Internal Audit, or a consulting firm. They must demonstrate awareness of the legal and regulatory environment in which IQVIA operates globally, including familiarity with the Office of Inspector General (OIG) Compliance Program Guidance, the U.S. Federal Anti-Kickback Statute, Corporate Integrity Agreements (CIAs), and U.S. Federal and State transparency reporting requirements, along with relevant global equivalents and industry codes. Furthermore, candidates should have experience in conducting compliance audits and monitoring related to the U.S. Foreign Corrupt Practices Act (FCPA), U.K. Bribery Act, and other relevant global anti-corruption laws and regulations.
Responsibilities
The Compliance Associate Director will assist with the operations of the Ethics and Compliance Office (ECO) by supporting IQVIA’s Risk Assessment, Audits and Monitoring (RAAM) function related to global Healthcare Compliance (HCC) and anti-bribery/anti-corruption (ABAC) risks. They will collaborate with other ECO members, IQVIA’s businesses, regions, and functions to develop and execute the annual audit plan, execute all phases of audits, coordinate updates on audit and monitoring activities, assist in establishing new systems and processes, manage RAAM projects and initiatives, develop risk perspectives and internal control recommendations, serve as an ambassador for the ECO program globally, and provide operational support to the ECO as assigned.
Skills
Compliance
Audit
Monitoring
Risk Assessment
FCPA
Bribery Act
Anti-Corruption
Regulatory Environment
OIG Guidance
Internal Audit
Quality Assurance
IQVIA
Advanced analytics and clinical research services
About IQVIA
IQVIA provides advanced analytics, technology solutions, and clinical research services specifically for the life sciences industry. Their services utilize extensive data resources and technology to create connections within healthcare, allowing clients to gain insights that help speed up the development and marketing of new medical treatments. This process is facilitated by their IQVIA Connected Intelligence™ system, which offers quick and flexible insights. IQVIA stands out from competitors by focusing on patient privacy, employing various technologies to protect individual data. The company's goal is to enhance healthcare outcomes by supporting biotech, pharmaceutical, and medical device companies, as well as researchers and government agencies, in understanding diseases and advancing medical science.
Durham, North CarolinaHeadquarters
1998Year Founded
$3,526MTotal Funding
POST_IPO_EQUITYCompany Stage
Cybersecurity, Biotechnology, HealthcareIndustries
10,001+Employees