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Quality Assurance, CQV Lead
Telix Pharmaceuticals Limited. Provide Quality Assurance oversight for commissioning, qualification, validation, and operational readiness activities 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 Quality Assurance and Validation processes, with a strong focus on Commissioning, Qualification, and Validation (CQV) activities in compliance with cGMP requirements. Proficient in risk management, quality systems implementation, and regulatory oversight within the pharmaceutical and biotechnology sectors.
Highest-signal resume keywords
Quality Assurance OversightCommissioning, Qualification, Validation (CQV)CGMP ComplianceValidation Master Plans (VMPs)Risk Management
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
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Hard Skills
Quality AssuranceValidationCommissioningQualificationValidation Master Plans (VMPs)User Requirement Specifications (URS)Design Qualification (DQ)IQ/OQ/PQ ProtocolsSOP WritingRisk Assessments
Soft Skills
CollaborationCommunicationProblem-SolvingAttention to DetailLeadership
Industry Keywords
CGMP RequirementsPharmaceutical IndustryBiotechnology IndustryRadiopharmaceutical Industry21 CFR Parts 210, 211, 212Quality ControlRegulatory AffairsData IntegrityQuality CultureOperational Readiness
About the role
Key responsibilities & impact- Provide Quality Assurance oversight for commissioning, qualification, validation, and operational readiness activities across the Telix Manufacturing Solution network
- Review and approve validation lifecycle documentation, including VMPs, risk assessments, protocols, reports, and qualification documentation
- Ensure facility startup, expansion, and remediation activities comply with applicable cGMP requirements
- Apply risk-based approaches to commissioning, qualification, and validation
- Support implementation of quality systems, procedures, and governance for transition to routine GMP operations
- Review and approve deviations, investigations, CAPAs, change controls, and quality risk assessments related to CQV
- Promote data integrity, quality culture, and GMP compliance
- Partner with Engineering, Validation, Manufacturing, Quality Control, IT, and Regulatory Affairs
- Monitor project milestones, validation deliverables, and site-readiness metrics; escalate compliance risks
- Support technology transfers, manufacturing readiness, site activation, and handoff to on-site Quality Assurance and Quality Control teams
- Lead readiness activities for regulatory inspections and internal or customer audits
- Coordinate and monitor contractors, validation consultants, engineering firms, and service providers supporting CQV activities
- Support facility construction and expansion, equipment and utility qualification, computerized systems validation, process validation, and operational readiness
- Report to the Quality Director, Manufacturing Expansion & Readiness
- Travel extensively across the U.S. Telix Manufacturing Solution network, with travel expected to exceed 75% and possible multi-week site stays
Requirements
What you’ll need- Bachelor’s degree required, oriented in Pharmacy, Chemistry, Biochemistry, Engineering, Microbiology, Life Sciences, or a related scientific discipline
- 5 years of experience in Quality Assurance, Validation, Engineering Quality, or CQV within the pharmaceutical, biotechnology or radiopharmaceutical industry
- Minimum 5 years of direct experience supporting Commissioning, Qualification, and Validation (CQV) activities for GMP facilities and manufacturing systems
- Experience reviewing and approving Validation Master Plans (VMPs), User Requirement Specifications (URS), Design Qualification (DQ), IQ/OQ/PQ protocols, risk assessments, and validation reports
- Technical understanding of manufacturing, quality and regulatory requirements
- Experience writing and reviewing SOPs
- Willingness and ability to travel more than 75% across multiple U.S. manufacturing sites, including extended stays of several weeks
- English language
- Knowledge of applicable cGMP requirements, including 21 CFR Parts 210, 211, and 212
- Ability to work with validation documentation, quality systems, risk management, deviations, investigations, CAPAs, and change controls
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 the company