Director, Clinical Ops Compliance & Inspection Readiness
The Lotus Group LLC
Turn this role into an interview — a resume and cover letter built around what this employer wants.
Benefits offered by this job
Job summary
The Lotus Group LLC in Alameda (Outside San Francisco) seeks a Director/AD, Clinical Operations Compliance to lead GCP/ICH-GCP compliance, risk management, and CAPA governance. You will partner with QA, Clinical Development, and CROs to ensure inspection readiness and robust compliance systems.
This role offers strong ownership, cross-functional influence across study teams, and relocation support for candidates moving to Alameda.
Qualifications
- Requires extensive GCP/ICH-GCP experience embedded in Clinical Operations.
- Proven CAPA ownership with root-cause analysis and closure.
- Ability to influence QA and cross-functional teams.
Responsibilities
- Lead GCP/ICH-GCP compliance and CAPA governance within Clinical Operations.
- Build and improve compliance processes, risk registries, metrics and controls.
- Partner with QA, Clinical Development and CROs to ensure inspection readiness.
Skills
Education
Job description
The Lotus Group LLC in Alameda (Outside San Francisco) seeks a Director/AD, Clinical Operations Compliance to lead GCP/ICH-GCP compliance, risk management, and CAPA governance. You will partner with QA, Clinical Development, and CROs to ensure inspection readiness and robust compliance systems.
This role offers strong ownership, cross-functional influence across study teams, and relocation support for candidates moving to Alameda.
'/%3e%3cpath%20d='M101.744%2012.4726L102.894%2016.1947L99.0021%2013.2201L101.744%2012.4726ZM105.3%208.40937H100.488L99.0026%203.59473L97.5116%208.41047L92.7%208.40385L96.5965%2011.3834L95.1055%2016.1942L99.0021%2013.2196L101.408%2011.3834L105.3%208.40992V8.40937Z'%20fill='white'/%3e%3cdefs%3e%3clinearGradient%20id='paint0_linear_5593_1381'%20x1='90'%20y1='9.44471'%20x2='99'%20y2='9.44471'%20gradientUnits='userSpaceOnUse'%3e%3cstop%20stop-color='%2300AD70'/%3e%3cstop%20offset='0.998594'%20stop-color='%2300B67A'/%3e%3cstop%20offset='1'%20stop-color='%23DCDCE6'/%3e%3c/linearGradient%3e%3c/defs%3e%3c/svg%3e){kind=small}
