GCP Compliance Lead - Quality & Regulatory

Alcon; Lake Forest (CA); Vor Ort; USD 111.000 - 143.000; Vollzeit

Zusammenfassung

Alcon, a leading eye-care company, seeks a Manager, Good Clinical Practices to lead compliance activities within the QA Compliance Team. This role supports Fort Worth, TX, Durham, NC, Johns Creek, GA, or Lake Forest, CA and involves external audits, CAPA coordination, and implementation of GCP/GLP regulatory requirements.

You will manage projects, ensure SOPs are followed, and drive continuous quality improvements across studies, facilities, and suppliers, with up to 60% travel and onsite work.

Qualifikationen

• Bachelor's Degree or Equivalent years of directly related experience.
• 5+ years of relevant experience in regulatory/compliance.
• Experience with audits and CAPA processes.
• Onsite work location in the US; travel up to 60%.

Aufgaben

• Manage individual projects, applying advanced knowledge to achieve objectives and impact performance.
• Oversee day-to-day operations, ensuring productivity and alignment with objectives.
• Make operational decisions, managing programs, resources, and schedules.
• Ensure implementation of quality management systems at each stage of process/operations.
• Implement QA regulations and SOPs; write, revise, and approve SOPs.
• Perform and support audits/inspections of studies/facilities/equipment/suppliers.

Kenntnisse

GCP audit track record

Quality compliance

Regulatory awareness

Ausbildung

Bachelor's Degree or Equivalent

Jobbeschreibung

Alcon, a leading eye-care company, seeks a Manager, Good Clinical Practices to lead compliance activities within the QA Compliance Team. This role supports Fort Worth, TX, Durham, NC, Johns Creek, GA, or Lake Forest, CA and involves external audits, CAPA coordination, and implementation of GCP/GLP regulatory requirements.

You will manage projects, ensure SOPs are followed, and drive continuous quality improvements across studies, facilities, and suppliers, with up to 60% travel and onsite work.