• Support the HPQE in GCSO quality and compliance infrastructure development; assist with creation/revision of appropriate quality and compliance policies, Standard Operating Procedures (SOPs), processes, and best practices as needed.
• Work in collaboration with Clinical Development Quality, Patient Safety, Regulatory Affairs, strategic partners, and other stakeholders to ensure compliance with International Council for Harmonization of Technical Requirements for Pharmaceutical for Human Use (ICH) GCP, GLP, PV and relevant local and international regulations and to ensure inspection readiness.
• Participate in Audit and Inspection planning with Clinical Development Quality and Pharmacovigilance Quality Assurance.
• Represent or ensure GCSO representation and preparation during audits/inspections (on-site at the client by internal and external parties).
• Attend improvement initiatives to improve quality and compliance processes and effectiveness in collaboration with stakeholders.
• Stay abreast with GCP, GLP, regulatory, and industry trends. Share key information gathered via professional associations and conferences (upcoming regulations, best

practices) within the GCSO Practice, Global Regulatory Affairs, and Clinical Quality Assurance.

• Provide relevant GCP, GLP, and PV guidance and training to GCSO staff for all phases of clinical drug development.
• Support Corrective and Preventive Action (CAPA) activity for internal (system) audits and findings from any audits and inspections where findings are raised to the client in conjunction with department managers and subject matter experts. This includes CAPA tracking and monitoring for timely closure.
• Partner with colleagues/others to (proactively) identify and mitigate compliance risks, resolve potential compliance observations and escalate critical compliance risks to Clinical Quality Management Lead.
• Represent GCSO in clinical team meetings and discussions as needed.
• All other duties as assigned.

Requirements

• Several years of pharmaceutical experience, preferably in a global Quality Assurance or a Clinical Development setting.
• In depth experience of GCP and GVP, including hands on experience in global GCP audits and/or inspections.
• Couple of years of experience in SOP writing essential.