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Senior Manager, Clinical Quality
Telix Pharmaceuticals Limited. Establish, implement and maintain quality assurance processes and documented procedures for compliant clinical trials and reliable clinical data .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in establishing and maintaining quality assurance processes for compliant clinical trials, with a strong focus on regulatory compliance and quality oversight. Proficient in conducting audits, managing CAPAs, and collaborating with cross-functional teams to ensure adherence to industry standards.
Highest-signal resume keywords
Quality Assurance ProcessesGCP AuditsRegulatory ComplianceClinical Quality ManagementASQ Certification
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Clinical Trial ManagementAudit PlanningCAPA TrackingRisk ManagementData ManagementSOP DevelopmentTemperature Excursion ReviewProduct Complaint InvestigationQuality Gap AnalysisRegulatory Inspection Preparation
Soft Skills
Time ManagementOral CommunicationWritten CommunicationAttention to DetailProblem-Solving
Certifications & Qualifications
ASQ Certification in Quality AuditingASQ Certification in Quality ManagementSix Sigma Green BeltSix Sigma Black Belt
Industry Keywords
Biotech IndustryPharmaceutical IndustryFDA GuidelinesTGA RegulationsPMDA RegulationsICH GuidelinesEMEA Regulations
Tech Stack
Tools & technologiesGoogle Cloud Platform
About the role
Key responsibilities & impact- Establish, implement and maintain quality assurance processes and documented procedures for compliant clinical trials and reliable clinical data
- Plan, arrange, schedule and conduct GCP, GVP and GCLP audits and assessments
- Write audit plans, agendas and reports and track audit responses and resulting CAPAs
- Drive regulatory authority inspection preparation and coordinate inspection responses
- Provide quality oversight and compliance support to study, program, development and matrix teams
- Review essential documents and attend relevant team meetings
- Review, investigate and close temperature excursions, product complaints and clinical trial-related investigations
- Review critical processes and procedures to identify clinical-trial quality gaps
- Participate in risk management, data management, trial management and investigational product management initiatives
- Collaborate with Clinical Operations to write, revise and approve SOPs, Work Instructions and Forms
Requirements
What you’ll need- Bachelor’s degree in Life Sciences or related discipline required
- American Society for Quality (ASQ) Certification in Quality Auditing, Quality Management, Six Sigma Green Belt or Six Sigma Black Belt required
- 7+ 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 ability to work with a sense of urgency
- Strong oral and written communication, including 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
Benefits
Comp & perks- Competitive salaries
- Annual performance-based bonuses
- Equity-based incentive program
- Generous vacation
- Paid wellness days
- Support for learning and development
- Hybrid and remote work arrangements are available across Telix employees globally