Remote opportunity at
Telix Pharmaceuticals LimitedQuality Assurance, CQV lead
Telix Pharmaceuticals Limited operates globally as a radiopharmaceutical company focused on precision medicine, developing targeted radiation products to assist individuals dealing with cancer and rare diseases.…
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About This Role
Telix Pharmaceuticals Limited operates globally as a radiopharmaceutical company focused on precision medicine, developing targeted radiation products to assist individuals dealing with cancer and rare diseases. The organization is currently seeking a Quality Assurance, CQV Lead to join its team on a full-time basis. This position supports the international deployment of an approved prostate cancer imaging agent along with an expanding portfolio of late clinical-stage products. The role is remote-based…
Job Description
Telix Pharmaceuticals Limited operates globally as a radiopharmaceutical company focused on precision medicine, developing targeted radiation products to assist individuals dealing with cancer and rare diseases. The organization is currently seeking a Quality Assurance, CQV Lead to join its team on a full-time basis. This position supports the international deployment of an approved prostate cancer imaging agent along with an expanding portfolio of late clinical-stage products. The role is remote-based while simultaneously requiring extensive mobility and travel exceeding 75% across manufacturing sites in the United States, including potential multi-week stays depending on validation timelines.
This professional will provide key Quality Assurance oversight for facility construction, expansion, computerized systems validation, process validation, utility qualification, and operational readiness. The individual coordinates closely with various internal departments and external contractors to ensure all commissioning, qualification, and validation activities comply with relevant cGMP guidelines and internal quality systems. Ideal candidates possess a strong background in pharmaceutical or radiopharmaceutical quality assurance, demonstrate resilience and adaptability, and thrive in a dynamic, results-oriented environment.
Responsibilities
- Provide Quality Assurance oversight for commissioning, qualification, validation, and operational readiness across the manufacturing network
- Review and approve validation lifecycle paperwork including validation master plans, risk evaluations, protocols, and reports
- Evaluate and authorize deviations, CAPAs, change controls, and quality risk assessments related to CQV
- Monitor project milestones, validation deliverables, and readiness metrics while escalating compliance risks
- Coordinate contractors, validation consultants, engineering firms, and service providers supporting CQV operations
- Lead readiness procedures for regulatory inspections and internal or customer audits concerning facility startup and validation
Requirements
- Hold a Bachelor's degree in a scientific or engineering discipline such as Pharmacy, Chemistry, Biochemistry, Engineering, Microbiology, or Life Sciences
- Bring a minimum of five years of work history in Quality Assurance, Validation, Engineering Quality, or CQV within the pharmaceutical, biotechnology, or radiopharmaceutical sector
- Possess at least five direct years of experience supporting CQV activities for good manufacturing practice facilities and systems
- Demonstrate familiarity with reviewing and approving validation master plans, user requirement specifications, design qualifications, and IQ/OQ/PQ protocols
- Maintain the willingness and physical ability to travel over 75% of the time to multiple manufacturing locations with potential extended stays
- Demonstrate technical comprehension of manufacturing, quality, and regulatory requirements alongside standard operating procedure writing and reviewing experience
Qualifications
- Possess an advanced degree in a relevant scientific or engineering discipline
Core Skills
Benefits
- Competitive salaries
- Annual performance-based bonuses
- An equity-based incentive program
- Generous vacation time
- Paid wellness days
- Support for learning and development
Frequently Asked Questions
Answers are based only on the employer’s listing; where it doesn’t say, neither do we.
What is the employment type for this role?
This position is full-time.
What is the travel requirement for the QA, CQV Lead position?
Travel is expected to exceed 75% across United States manufacturing sites and may involve extended stays of several weeks depending on project schedules and validation milestones.
What educational background is required?
Applicants must have a Bachelor's degree focused in Pharmacy, Chemistry, Biochemistry, Engineering, Microbiology, Life Sciences, or a related scientific discipline, while an advanced degree is considered desirable.
How much salary does this position offer?
The specific salary is not stated in the source posting.
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