What are the responsibilities and job description for the Senior Manager, GCP/GVP Quality position at Staffing?
Position SummaryThis role is responsible for providing quality oversight for clinical development and pharmacovigilance activities. The Senior Manager, GCP/GVP Quality ensures that applicable regulatory standards are met, quality systems are maintained, and risk-based approaches are applied across clinical and safety operations. The position partners closely with internal teams to support inspection readiness, data reliability, and continuous improvement initiatives.Core ResponsibilitiesMaintain and enhance GCP and GVP quality processes supporting clinical trials and safety activitiesProvide quality input across the lifecycle of clinical studies, from planning through close-outApply quality risk management principles to identify and address compliance risksSupport internal, external, and vendor audits and inspections as requiredMonitor quality performance indicators and report trends to support process improvementPromote data integrity and compliance with global regulatory expectationsAct as a quality liaison for assigned clinical programs and cross-functional teamsProvide guidance on quality matters in project discussions and governance forumsCollaborationWorks cross-functionally with Clinical Operations, Clinical Development, Pharmacovigilance, Regulatory Affairs, Medical Affairs, and external partners to ensure consistent application of quality standards.Role ScopeIndividual contributor positionNo direct reportsQualificationsEducationBachelor’s degree in a scientific, healthcare, or technical discipline preferredProfessional ExperienceAt least 6 years of experience in a regulated pharmaceutical, biotechnology, or clinical research environmentDirect experience supporting clinical trial teams in a quality-focused capacityStrong understanding of GCP, GVP, and applicable global regulatory requirements, including ICH guidelines (e.g., ICH GCP E6 R3)Experience working with vendors, CROs, and external partnersFamiliarity with regulatory frameworks such as FDA and EU regulations; ISO exposure is beneficialExperience supporting audit preparation, documentation management, and inspection activitiesCompany DescriptionStaffing Company (Confidential)
Salary : $60 - $75