Global Compliance Specialist
AGC Biologics is a leading global Contract Development and Manufacturing Organization, with a deep commitment to improving life quality by bringing new biopharmaceuticals to market. Because of our dedication to building and empowering our internal teams, AGC Biologics is an innovative leader in the industry with an extensive network of cGMP facilities in the US, Europe and Asia. As such, we deliver a deep expertise, dynamic solutions and technologies, as well as customized services for the scale-up and cGMP manufacturing of protein-based therapeutics and cell and gene therapies. We forge exceptionally strong partnerships with our clients, and we never lose sight of our pledge to deliver a reliable and compliant drug substance supply, Right, On time. For more information, visit www.agcbio.com.
SUMMARY:
The Global Compliance Specialist primary purpose is to partner with the business to strengthen AGC Biologic's US practices to ensure compliance with SOX/JSOX (Japanese Sarbanes Oxley) and other applicable laws and statutes. The position will present the opportunity to build relationships with manager and to influence improvements throughout the organization. You will be required to understand business processes, system workflows, and technology to be able to identify risk and to guide business owners in defining effective and value added risk mitigation plans. This position will be based in Seattle, Washington or Boulder, Colorado and will report to the Global Compliance Manager, however as the role is global the position could support other AGC Biologics sites.
PRINCIPAL RESPONSIBILITIES:
- Develop strong relationships cross-functionally to fully understand the business and identify opportunities to mitigate compliance risk.
- Develop and conduct risk assessments to define risks to the business, and how each is mitigated.
- Create process documents, process maps, workflows and/or diagrams for processes when identifying areas of opportunity for process improvement.
- Propose and implement solutions for identified gaps.
- Support IT on the design, implementation and evaluation of IT general and automated system controls and configurations.
- Serve as a resource on all internal control matters, including development, refinement and documentation of internal controls, processes and procedures.
- Collaborate with employees and managers to provide training to build knowledge and understanding of internal control.
- Assist, when needed, with the company's internal controls program to be SOX (JSOX) compliant.
- Participate in meetings across multiple time zones to dictate important requirements and timelines.
- Coordinate and assist with internal and external audit to support testing, walkthroughs, process reviews and action plans.
KNOWLEDGE, SKILLS & ABILITIES:
- Familiarity with applicable industry laws and regulations; IFRS, IT and SOX (JSOX).
- Strong verbal and written communication skills with the ability to interact with all levels across the organization.
- Ability to identify problems, recommend effective solutions, and ensure that those solutions are implemented effectively and timely.
- Demonstrates global/enterprise-wide thinking; processes information through a strategic lens and applies tenants of systems thinking/theory and to issues/assignments.
- Familiarity with financial systems as they relate to reviewing and improving internal controls.
- Ability to work with internal teams to collect and analyze data.
- Well-developed communication and presentation skills to communicate with all levels of management.
- Experience in working with global markets and shared services.
- Ability to work independently in a decentralized location and to consistently meet stringent deadlines.
- Willingness to travel up to 25% domestic and internationally.
EDUCATION/EXPERIENCE:
- Bachelor's degree preferably in Accounting, Finance or an equivalent combination of education and relevant experience.
- Experience with Dynamics AX and Power BI a plus.
- A minimum of 8 years' experience in Finance, Audit, Operations, Risk Management, Compliance or related field.
- Professional certification including CIA and/or CISA a plus
- Big 4 Accounting firm exposure or large public company internal audit experience a plus.
- Experience working in a diverse environment.
AGC Biologics offers a highly competitive compensation package and a friendly, collaborative culture that values personal initiative and professional achievement. AGC Biologics is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, ancestry, color, family or medical care leave, gender identity or expression, genetic information, marital status, medical condition, national origin, physical or mental disability, political affiliation, protected veteran status, race, religion, sexual orientation, or any other characteristic protected by applicable laws, regulations and ordinances.