**General Description:** The incumbent will: + Lead the activities of the Global Regulatory Affairs SOP Committee regarding life-cycle management of Global Regulatory Affairs SOP compliance. To include but not limited to: + Chair the SOP Review Committee to ensure requirements are followed per applicable work instruction. + Assist GRA personnel through the Document Change Process + Guide external personnel to Global Regulatory Affairs to comply with SOP Review Committee requirements + Schedule and conduct adjudication meetings for issue resolution + Manage all applicable trackers/spreadsheets associated with the Global Regulatory Affairs SOP Committee. + Distribute SOP committee monthly reports. + Function as the chair of the Inspection Readiness Team. Leading the team to achieve the following goals (to include but not limited to): + To function as the GRA single point of contact for all notifications of internal audits and Health Authority (HA) Inspections impacting Global Regulatory Affairs (GRA). + To identify and mitigate process gaps that could potentially be considered compliance risks. + To assess GRA CAPAs to determine if the impact of the corrective actions pose a future compliance risk to other regions/functional areas of GRA. + Assist with the planning and coordination of training curricula for the Global Regulatory Affairs team. + Generate Change Management Form for Curricula Owner + Coordinate the modifications with Quality Training + Monitor delinquent training and assist personnel to achieve compliance + Guide managers in assigning their personnel the adequate parameters for on-boarding + Own and ensure the R Reg Affairs Global Reg Process & Compliance curriculum is updated and accurate. + **Continuous Monitoring and Reporting** + Establish metrics and KPIs to monitor the effectiveness of compliance monitoring and quality management activities. + Collaborate with Quality System record owners to promptly resolve overdue and/or nearly overdue records related to KPI reports. + Consistently provide senior management with reports on the progress of quality initiatives. + Support the global compliance team’s activities as assigned to include serving as liaison to BeiGene compliance activities external to GRA (to include but not limited to): + Information Governance (IG) Team + Clinical Operations Emergency Response Team + Global Standards Committee + Act as the GRA Point of Contact for Quality Initiatives to include but not limited to Quality Training and Quality Document Management Activities. Partner cross functionally with Quality to disseminate Quality Training as reviewed in Quality informational meetings. + Partner with Internal Audit Group to Conduct Gap Analysis + Post audit/inspection support in response to action items generated from the activity. + Assist in procurement of GRA Product Liability Insurance Responses. + Perform other duties as assigned. **Essential Functions of the job:** + Independently lead/participate in GxP compliance activities (internal/corporate, CMO or supplier, CRO) and identify regulatory compliance gaps or risks. + Assess, manage training curricula in response to CAPAs/audits and assess corrective measures for internal and external GxP Compliance audits. + Work with Global Quality Compliance and Regulatory teams to ensure accuracy of compliance data across BeiGene network sites. + Perform duties as assigned to ensure compliance to global and local regulations. **Supervisory Responsibilities:** + Team to be established including direct reports. **Computer Skills:** + Strong PC literacy required; MS Office skills (Outlook, Word, Excel, PowerPoint), MS SharePoint. **Experience/Education Required** : + Bachelor of Science degree, in a related scientific discipline or relevant professional certification. Requires a minimum of 8+ years’ experience in pharmaceutical, biologics, or biotechnology industry, with 5+ years of experience as a Regulatory Affairs compliance lead. **Other Qualifications:** + Spoken/Written fluency in English required. + Strong project management skill set. **Travel:** Must be able to travel approximately 25%, including international trips. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.