Senior Manager, Consulting
Bullhorn
Manager, Clinical Quality
Telix Pharmaceuticals Limited
full-time
Posted on:
Location Type: Remote
Location: Remote • 🇺🇸 United States
Visit company websiteJob Level
SeniorLead
About the role
- Establish, implement and maintain quality assurance processes and documented procedures.
- Plan, conduct and report audits and assessments of Good Clinical Practices (GCPs) and Good Pharmacovigilance Practices (GVP).
- Ensure accurate audit documentation from audits.
- Drive inspection preparation activities for regulatory authority inspections.
- Provide quality oversight and compliance support for various study teams.
- Ensure accurate review and investigation of clinical trial related investigations.
- Review processes to identify gaps in standards.
- Collaborate with Clinical Operations to write and revise SOPs.
Requirements
- Bachelor’s degree in Life Sciences or related discipline required; Master’s degree preferred.
- American Society for Quality (ASQ) Certification in Quality Auditing, Quality Management, Six Sigma Green Belt or Six Sigma Black Belt required.
- 7+ years of experience in Clinical Quality for Manager level and 9+ years in Clinical Quality for Sr. Manager level leading teams in the biotech/pharmaceutical industry
- Experience with FDA, TGA, PMDA, ICH and EMEA guidelines and regulations
- Excellent time management skills and the ability to work with a sense of urgency
- Strong oral and written communication including the ability to present information clearly and logically
- Ability to prioritize and manage multiple projects to meet critical deadlines
- Strong attention to detail and problem-solving skills
- Works effectively in a team environment.
Benefits
- Competitive salaries
- Annual performance-based bonuses
- Equity-based incentive program
- Generous vacation
- Paid wellness days
- Support for learning and development
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
quality assurance processesauditsGood Clinical Practices (GCP)Good Pharmacovigilance Practices (GVP)regulatory authority inspectionsclinical trial investigationsSOP writing and revision
Soft skills
time managementoral communicationwritten communicationprioritizationproject managementattention to detailproblem-solvingteam collaboration
Certifications
American Society for Quality (ASQ) Certification in Quality AuditingQuality Management CertificationSix Sigma Green BeltSix Sigma Black Belt
