FSPxGlobal Pharma Location: Shanghai client office based, Jingan district, Park Place Therapeutic area: global phase II-III studies in Oncology, Immune and Respiratory, Diabetes and CNS The Compliance Manager role is an integral part of the quality management system in the company. The compliance manager plays a critical role in supporting Medicine for GxP Compliance issues and driving the organization on the pro-active quality management. He/She provides GxP guidance and consultation. The position provides assessments of activities in Medicine with company procedures, GxP, ICH guidelines and other regulations; identifies and assesses areas of risk; proposes corrective and preventative actions; assists with development and implementation of process improvements. Responsibilities: Compliance expert: - Provide GxP/Regulatory/SOP/WI/KMed Asset guidance, consultation, coaching, mentoring, including sharing of best practices within the OPU/regional Medicine organization as required. - Liaises with international CPM colleagues regarding compliance topics. Quality Improvement: - Identify and support improvement actions within the OPU/regional Medicine organization, aligned with global quality improvement projects and compliance strategy - Identify areas for improvement and support the initiation of quality improvement projects. - Identify areas of improvement for quality management in the OPU/region responsible. - Support Global quality improvement projects where appropriate. CRO Quality Management: - Assess and ensure implementation of relevant SOPs & WIs at CROs conducting trials. - Ensure pre-qualification visits at new CROs are performed, in collaboration with other functions, as applicable. - Ensure oversight of Quality related risk in relation to vendor management and development of mitigating actions in collaboration with other functions, as applicable. - Support business partners in the investigations and development of CAPA plans related to CRO non- Compliances. - Pro-actively works with business partners in incorporating quality elements into scopes of Work Regulatory Inspection support: - Lead inspections and drive inspection processes as needed ( e.g. Primary contact person, inspection lead) - Support and provide guidance relating to optimized inspection readiness and inspection preparation activities. - Lead and represent compliance position in regulatory authority inspections, as appropriate. - Ensure inspection findings are appropriately addressed; response provided and adequately followed up. Corrective and Preventive action process: - Provide support to auditee, as appropriate, including review of audit action plans as proposed by business function. - Support/ facilitate the handling of major and critical non-compliances as detailed in corporate SOP. - Ensure KPI timelines adhered to, tracked and followed up as applicable. - Analyse non-compliance trends and provide periodic updates to management of the OPU/ region. Participate in global compliance projects, as applicable. Job Expertise Proficient in business critical compliance and quality management and enabling compliance standards and oversight. Considerable experience of GCP/Pharmacovigilance quality management systems. Good understanding of Medicine processes in product development and post approval. Degree/ Education: Bachelors and/or Master Degree and/or Doctoral Degree Major/ Focus: Medicine and/or Pharmaceutics and/or others Required Capabilities Skills: 61 Proficient/expert knowledge in ICH GCP, Pharmacovigilance and/or Regulatory Affairs and applicable regulations/guidelines (6+ years’ experience in clinical trial management and/or indepth knowledge of clinical development process). 61 Experience with/participation in Regulatory Authority Inspections 61 Excellent communication, collaboration, and decision making skills 61 Ability to act independently and effectively prioritize. 61 Ability to communicate/liaise with all levels of the organization 61 Good team working capabilities 61 Ability to travel regionally and internationally as needed. Language Skills & Proficiency: English (Read: fluent;Write: fluent;Speak: fluent); Chinese (Read: fluent;Write: fluent;Speak: fluent) Experience: 1-3 years of leadership experience; Experience in managing projects; International exposure in daily business (＞50% of international business/customers/staff) ＞ 1.5 years Special Working Experience: - 6+ years experience in GxP environment and in-depth knowledge of clinical development processes. - Proficient/ expert knowledge in ICH GxP and applicable regulations/guidelines. - Experience with/participation in Regulatory Authority Inspections preferred. - Experience in Quality Management. - Current knowledge in applicable Company processes and procedures. - Ability to assess impact of these processes/ procedures across Medicine.
