Senior Manager, Clinical Quality

Telix Pharmaceuticals (AMER)

About The Position

The Senior Manager, Clinical Quality will establish, implement and maintain quality assurance processes and documented procedures to ensure clinical trials are conducted and clinical data are generated, recorded and reported in compliance with protocols, Good Clinical Practice (GCP), and applicable regulatory requirements. The role provides quality oversight and compliance support for Telix’s early- and late-stage assets. The position plans, conducts and reports audits and assessments covering GCP, Good Pharmacovigilance Practices (GVP), and Good Clinical Laboratory Practices (GCLP). Audited areas may include vendors, clinical investigator sites, laboratories, databases, essential documents, systems, processes and procedures. The role also supports regulatory inspection readiness and responses, collaborates with Clinical Operations on quality documentation, and contributes to critical quality initiatives.

Requirements

Bachelor’s degree in Life Sciences or a related discipline.
ASQ certification in Quality Auditing, Quality Management, Six Sigma Green Belt or Six Sigma Black Belt.
At least 7 years of Clinical Quality experience for the Senior Manager level, leading teams in the biotech or pharmaceutical industry.
Experience with FDA, TGA, PMDA, ICH and EMEA guidelines and regulations.
Excellent time-management skills and ability to work with a sense of urgency.
Strong oral and written communication skills, including the ability to present information clearly and logically.
Ability to prioritize and manage multiple projects to meet critical deadlines.
Strong attention to detail and problem-solving skills.
Commitment to excellence, results orientation, creativity and innovation, effective communication, collaboration, resilience, an inclusive mindset, adaptability, ethical behavior and continuous learning.

Nice To Haves

Master’s degree.

Responsibilities

Plan, arrange, schedule and conduct audits and assessments to ensure compliance with GCP, GVP and GCLP.
Prepare audit plans, agendas and reports for audits of clinical investigator sites, CROs, supporting laboratories, monitoring organizations and other vendors; track audit responses and resulting CAPAs.
Drive preparation for regulatory authority GCP, GCLP and GVP inspections and coordinate inspection responses.
Provide quality oversight and compliance support to study, program, development and matrix teams by attending meetings, representing Clinical Quality and reviewing essential documents.
Review, investigate and close temperature excursions, product complaints and clinical-trial-related investigations accurately and on time.
Review critical processes and procedures to identify gaps in standards, procedures and technologies that could put clinical-trial quality at risk.
Participate in initiatives involving critical quality processes, including risk management, data management, trial management and investigational product management.
Collaborate with Clinical Operations to write, revise and approve SOPs, Work Instructions and Forms.