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Quality Control, Validation Lead
Telix Pharmaceuticals Limited. Support QC laboratory startup, qualification, validation, and operational readiness across the Telix Manufacturing Solution network .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in GMP-compliant laboratory systems, analytical method development, and regulatory compliance within the pharmaceutical and biotechnology sectors. Proficient in managing laboratory operations, including validation, documentation, and quality control processes.
Highest-signal resume keywords
GMP Laboratory OperationsAnalytical Method DevelopmentRegulatory Compliance (FDA, ICH, USP)Analytical Lifecycle ManagementLaboratory Investigations and CAPAs
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
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Hard Skills
Analytical Method ValidationEquipment CalibrationData IntegrityStability ProgramsAnalytical SpecificationsQuality Control DocumentationRoot Cause AnalysisRegulatory SubmissionsChange Control ManagementMethod Transfer
Soft Skills
LeadershipCollaborationProblem-SolvingCommunication
Industry Keywords
Pharmaceutical IndustryBiotechnologyRadiopharmaceuticalsQuality ControlGMP ComplianceAnalytical TestingRegulatory InspectionsOOS/OOT InvestigationsCAPA Management21 CFR 211 and 212
About the role
Key responsibilities & impact- Support QC laboratory startup, qualification, validation, and operational readiness across the Telix Manufacturing Solution network
- Coordinate equipment calibration, maintenance, qualification, and lifecycle
- Establish GMP-compliant laboratory systems, procedures, documentation, and data integrity
- Transition validated laboratories to on-site QC
- Lead analytical method development, transfer, verification, and validation for clinical and commercial manufacturing
- Support technology transfers for new products, processes, and analytical methods
- Coordinate internal and contract laboratory activities
- Develop and maintain stability programs and protocols
- Author and maintain analytical methods, specifications, protocols, reports, and QC documentation
- Review analytical data, validation results, deviations, OOS/OOT investigations, CAPAs, and change controls
- Lead root cause analysis for analytical failures, atypical results, and quality events
- Maintain readiness for regulatory inspections and internal or customer audits
- Support analytical content for regulatory submissions and health authority responses
- Standardize and improve QC practices, analytical procedures, and validation approaches across the TMS network
- Travel more than 75% to provide on-site support for startup, qualification, validation, and commercial readiness
Requirements
What you’ll need- Bachelor's degree required in Chemistry, Biochemistry, Pharmaceutical Sciences, Analytical Chemistry, Microbiology, Radiochemistry, or related scientific discipline
- Advanced degree preferred
- Strong knowledge of FDA, ICH, USP, and applicable regulatory requirements governing Quality Control laboratories and analytical testing, including 21 CFR 211 and 212
- Experience in development, validation, or GMP laboratory operations within the pharmaceutical, biotechnology, or radiopharmaceutical industry
- Demonstrated experience in analytical method development, method validation, method transfer, and analytical lifecycle management
- Experience supporting laboratory investigations, OOS/OOT events, deviations, CAPAs, change controls, and regulatory inspections within a GMP environment
- Experience authoring, reviewing, and approving analytical methods, specifications, validation protocols, reports, investigations, and GMP laboratory documentation
- Willingness and ability to travel extensively (>75%) across multiple US manufacturing sites, including staying for several weeks at a site
- English language
Benefits
Comp & perks- Competitive salaries
- Annual performance-based bonuses
- Equity-based incentive program
- Generous vacation
- Paid wellness days
- Support for learning and development