Senior Manager, Clinical Quality — Remote & Equity Eligible

Telix Pharmaceuticals Limited; United States; Hybrid; USD 120.000 - 180.000; Vollzeit

Benefits dieser Stelle

Hybrid/Remote work

Annual bonus

Equity incentive

Generous vacation

Wellness days

Professional development

Zusammenfassung

Telix Pharmaceuticals Limited is seeking a Senior Manager, Clinical Quality to establish and maintain QA processes ensuring trials comply with protocol, GCP, and regulatory requirements. You will audit vendors, sites, and labs, prepare inspection responses, and provide oversight across study teams.

The role requires ASQ certification and 4+ years managing clinical quality in biotech/pharma, with strong regulatory knowledge and excellent communication skills.

Qualifikationen

• Bachelor's degree in Life Sciences or related discipline; ASQ Certification in Quality Auditing/Quality Management or Six Sigma is required.
• 4+ years in Clinical Quality for Manager level and 7+ years for Sr. Manager level leading teams in biotech/pharma.
• Experience with FDA, TGA, PMDA, ICH and EMEA guidelines and regulations.
• Excellent time management and ability to work with urgency; strong written and verbal communication.

Aufgaben

• Plan, arrange, schedule and conduct audits to ensure GCP/GVP/GCLP compliance.
• Write audit plans, agendas, and reports; track CAPAs and audit responses.
• Lead inspection preparation for regulatory inspections and coordinate responses.
• Provide quality oversight to study, program, development and matrix teams by attending meetings and reviewing documents.
• Investigate deviations, temperature excursions, product complaints and trials investigations.
• Identify gaps in standards and technologies that risk trial quality; review processes and SOPs.
• Participate in risk management, data management, trial management, and investigational product management initiatives.
• Collaborate with Clinical Operations to write, revise, and approve SOPs and forms.

Kenntnisse

Quality Auditing

GCP/GCLP/GVP

Audit documentation

Inspection readiness

Quality oversight

Regulatory compliance

Risk management

CRO coordination

Data review

Clinical operations collaboration

Ausbildung

Bachelor's in Life Sciences

ASQ Certification (Auditing/Management/Six Sigma)

Jobbeschreibung

Telix Pharmaceuticals Limited is seeking a Senior Manager, Clinical Quality to establish and maintain QA processes ensuring trials comply with protocol, GCP, and regulatory requirements. You will audit vendors, sites, and labs, prepare inspection responses, and provide oversight across study teams.

The role requires ASQ certification and 4+ years managing clinical quality in biotech/pharma, with strong regulatory knowledge and excellent communication skills.