Remote opportunity at
Telix Pharmaceuticals LimitedSenior Manager, Clinical Quality
Telix Pharmaceuticals Limited seeks a Senior Manager, Clinical Quality to join its remote team. The company focuses on precision medicine and targeted radiation to develop treatments…
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About This Role
Telix Pharmaceuticals Limited seeks a Senior Manager, Clinical Quality to join its remote team. The company focuses on precision medicine and targeted radiation to develop treatments for cancer and rare diseases, with an operational presence spanning multiple international regions. This position supports the worldwide introduction of an approved prostate cancer imaging agent alongside late-stage clinical portfolios. The person in this role will establish and uphold quality assurance frameworks to guarantee…
Job Description
Telix Pharmaceuticals Limited seeks a Senior Manager, Clinical Quality to join its remote team. The company focuses on precision medicine and targeted radiation to develop treatments for cancer and rare diseases, with an operational presence spanning multiple international regions. This position supports the worldwide introduction of an approved prostate cancer imaging agent alongside late-stage clinical portfolios.
The person in this role will establish and uphold quality assurance frameworks to guarantee that clinical trials adhere to protocols, Good Clinical Practices, and relevant regulatory standards. Duties involve scheduling and executing vendor, site, and laboratory audits, steering inspection readiness, and offering compliance guidance across development groups. Candidates will also review technical processes, handle temperature excursions or product complaints, and partner with clinical operations on standard operating procedures.
This position requires an individual capable of managing multiple assignments with urgency while coordinating inspection responses and corrective action plans. Qualified candidates will possess a background in biotechnology or pharmaceutical quality assurance, alongside knowledge of global regulatory guidelines.
Responsibilities
- Plan and conduct audits covering Good Clinical Practices, Good Pharmacovigilance Practices, and Good Clinical Laboratory Practices
- Draft audit plans, agendas, and reports for clinical sites, contract research organizations, laboratories, and vendors
- Monitor audit responses and track resulting corrective and preventive actions
- Lead inspection preparation activities for regulatory authority reviews and coordinate responses
- Deliver quality oversight by joining program teams, representing clinical quality, and reviewing essential documents
- Oversee the timely review and resolution of temperature excursions, product complaints, and trial investigations
- Examine critical processes to identify compliance gaps and risk factors affecting trial quality
- Collaborate with clinical operations to draft, revise, and approve standard operating procedures, work instructions, and forms
Requirements
- Bachelor degree in Life Sciences or a related discipline
- At least 4 years of clinical quality experience for the manager level, or 7 years for the senior manager level leading teams within the biotech or pharmaceutical sector
- Familiarity with FDA, TGA, PMDA, ICH, and EMEA guidelines and regulations
- Proficiency in managing multiple projects to meet deadlines with a strong sense of urgency
Qualifications
- Master degree
- American Society for Quality Certification in Quality Auditing, Quality Management, Six Sigma Green Belt, or Six Sigma Black Belt
Core Skills
Benefits
- Competitive salaries
- Annual performance-based bonuses
- Equity-based incentive program
- Generous vacation
- 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.
Is this position remote?
Yes, this role is listed as remote.
What is the employment type?
The employment type is full-time.
What education or certifications are required?
A bachelor degree in Life Sciences or a related discipline is required. A master degree or certifications from the American Society for Quality or Six Sigma are also noted in the qualifications.
What is the salary for this role?
The source posting does not specify a salary.
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