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Director, US Healthcare Compliance Audit
at Amgen Inc.
The Director is responsible for examining and evaluating business activities and related risks for ensuring regulatory healthcare compliance, safeguarding company assets and improving Amgen’s system of internal controls. This position is responsible for providing leadership and strategic direction in the development and execution of Amgen’s U.S. Healthcare Compliance Internal Audit (HCCIA) program and reports into the Executive Director Compliance. The position is responsible for managing a team, overseeing the execution of the audits, and reporting audit results to the Chief Compliance Officer and Senior Management. In addition, this position is responsible for developing close collaboration and strategic partnership with other audit and monitoring functions within Amgen.
The Director is responsible for managing a team of Auditors responsible for conducting HCC audits, vendor audits, and consulting engagements in the US. The Director is also responsible for managing the Senior Audit Manager that conducts International HCC and Anti-Bribery & Anti-Corruption (ABAC) audits, in partnership with the International Corporate Audit team.
The position is responsible for managing all aspects of the HCCIA program, which include:
- Single point of accountability for audit goals, budget, staffing and operations.
- Work with the Executive Director, conduct a continuous risk assessment, develop audit plan, and obtain approval by the Chief Compliance Officer.
- Progressively manage, recruit and develop a professional audit staff with sufficient knowledge, skills, experience and professional certifications to achieve effective auditing, consistent with Amgen’s strategic direction, and with emphasis on leadership development.
- Responsible for identifying and mentoring new talent for Amgen through networking and outreach
- Oversee the execution of all U.S. HCC audits and consulting engagements
- Develop and Maintain strategic relationships and close collaborations with Healthcare Compliance Leads, Healthcare Compliance Monitoring, Investigations, Policy, Training, and Communications groups as well as the Data Privacy and Trade Compliance group
- Actively participate in Audit Leadership Forum which includes the leads from Amgen audit organizations and provide periodic updates to the Audit Steering Committee
- Collaborate with and provide Oversight to international audit activities, including FCPA/ABAC issues, hiring, training as well as team building.
- Partner with the International Corporate Audit team to conduct affiliate and distributor audits covering International HCC and Anti-Bribery & Anti-Corruption (ABAC) compliance
- Work closely with Corporate Audit and Global R&D Compliance Audit leadership to share audit plans and conduct joint audits and consulting engagements (as necessary)
- Communicate audit results to Chief Compliance Officer, Executive Director Compliance, and Senior Management
- Work at the direction of Law Department and/or external counsel to conduct privileged audits and assessments
- Develop and update Audit Charter, Audit Manual, and other relevant documents governing the functioning of the HCCIA program
- Demonstrate a high level of professionalism and the ability to manage multiple projects
- Exercise excellent judgment and initiative in handling business issues
- Strong written and verbal communication skills
- Strong interpersonal skills, judgment, maturity, and flexibility
- Ability to manage competing priorities and provide a high level of responsiveness across multiple stakeholders
- Demonstrated ability to deliver against critical business objectives, implement complex instructions, prioritize, be proactive, resolve conflicts, follow through on assignments, and be a team player.
- Travel up to 15% per year; including international travel
- Position is based in Thousand Oaks, CA
Doctorate degree & 4 years of directly related experience
Master’s degree & 8 years of directly related experience
Bachelor’s degree & 10 years of directly related experience
- 5 years of Healthcare Compliance (HCC) audit experience in the pharmaceutical / biotechnology industry
- Prior pharmaceutical / biotechnology compliance, sales and marketing, medical liaison, or other relevant business experience
- Master’s degree in business administration, compliance or accounting
- Relevant auditing or compliance professional certifications: Certified Internal Auditor (CIA), Certified Public Accountant (CPA), Certified Compliance and Ethics Professional (CCEP), Certified Information Systems Auditor (CISA), Certified Fraud Examiner (CFE)
- Sound knowledge and understanding of Office of Inspector General (OIG) Compliance Program Guidance for Pharmaceutical Manufacturers, Pharmaceutical Research and Manufacturers of American (PhRMA) Code, U.S. Federal Anti-Kickback Statute, Corporate Integrity Agreements (CIAs), Accreditation Council for Continuing Medical Education (ACCME) guidelines, Prescription Drug Marketing Act, FDA commercial guidelines, and U.S. Federal and State transparency reporting requirements
- Experience in conducting compliance audits related to U.S. Foreign Corrupt Practices Act (FCPA), U.K. Bribery Act and other local anti-corruption laws and regulations
- Experience in conducting data privacy and trade compliance audits
If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.
Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.
As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.
Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.
Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.