Senior Manager, Clinical Quality — Hybrid/Remote + Equity

Telix Pharmaceuticals (AMER); Oregon; Hybrid; USD 140,000 - 190,000; Full time

Benefits offered by this job

Equity-based incentives

Bonuses

Paid wellness days

Learning & development support

Job summary

Telix Pharmaceuticals is expanding a Senior Manager, Clinical Quality role to establish and maintain QA processes ensuring trials meet protocol, GCP, GVP, and GCLP standards. The role oversees audits of sites, CROs, labs and vendors, coordinating CAPAs and inspection responses across early and late-stage assets.

You will partner with Clinical Operations and development teams to review documents, drive quality improvements, and ensure timely escalation of issues, with a strong emphasis on

Qualifications

• Bachelor's in Life Sciences or related field.
• Master's degree preferred.
• ASQ Certification in Quality Auditing/Quality Management or Six Sigma required.
• 4+ years in Clinical Quality at Manager level and 7+ years for Sr. Manager in biotech/pharma.

Responsibilities

• Plan, conduct and manage audits/assessments for GCP/GVP/GCLP compliance.
• Maintain audit documentation including plans, agendas, reports and CAPAs.
• Lead inspection readiness for regulatory GCP/GCLP/GVP inspections and coordinate responses.
• Provide quality oversight to study teams by attending meetings and reviewing essential documents.
• Investigate and close out temperature excursions, product complaints and trial-related investigations.
• Identify gaps in standards and procedures to manage risk to trial quality.
• Lead initiatives in risk management, data/trial management, and investigational product control.
• Collaborate with Clinical Operations to write and approve SOPs and forms.

Skills

Quality Auditing

Quality Management

Regulatory Knowledge

Leadership

Effective Communication

Education

Bachelor's degree in Life Sciences or related

Master's degree

ASQ Certification (Quality Auditing/Quality Management/Six Sigma)

Job description

Telix Pharmaceuticals is expanding a Senior Manager, Clinical Quality role to establish and maintain QA processes ensuring trials meet protocol, GCP, GVP, and GCLP standards. The role oversees audits of sites, CROs, labs and vendors, coordinating CAPAs and inspection responses across early and late-stage assets.

You will partner with Clinical Operations and development teams to review documents, drive quality improvements, and ensure timely escalation of issues, with a strong emphasis on