The Senior Process Quality Excellence Specialist (SPQES) will support the Head of Process Quality Excellence (HPQE) for GCSO in developing and maintaining its clinical quality systems/procedures and ensuring quality and compliance risks are appropriately identified and mitigated. Activities include all aspects of clinical studies that are managed by Global Clinical Sciences and Operations (GCSO) and requires a focus on Good Clinical Practice (GCP), Good Laboratory Practices (GLP), and Pharmacovigilance (PV) regulations and guidance.
Responsibilities:
• 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 Global 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.
• Lead and drive GCSO Inspection Readiness Activities across all GCSO functions working closely with the relevant inspection team(s).
• Participate in Audit and Inspection planning with Global Quality
• Represent or ensure GCSO representation including preparation during audits/inspections
• Support GCSO staff with audit/inspection responses, where required.
Requirements:
• 8+ 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.
• 2+ years of experience in SOP writing essential.