Senior Manager, Clinical Quality

Telix Pharmaceuticals (AMER); Oregon; Hybrid; USD 140.000 - 190.000; Vollzeit

Benefits dieser Stelle

Equity-based incentives

Bonuses

Paid wellness days

Learning & development support

Zusammenfassung

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

Qualifikationen

• 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.

Aufgaben

• 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.

Kenntnisse

Quality Auditing

Quality Management

Regulatory Knowledge

Leadership

Effective Communication

Ausbildung

Bachelor's degree in Life Sciences or related

Master's degree

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

Jobbeschreibung

Telix Pharmaceuticals is a dynamic, fast-growing radiopharmaceutical company with offices in Australia (HQ), Belgium, Japan, Switzerland, and the United States. Our mission is to deliver on the promise of precision medicine through targeted radiation. At our core, we exist to create products that seek to improve the quality of life for people living with cancer and rare diseases. You will be supporting the international roll-out of our approved prostate cancer imaging agent and helping us to advance our portfolio of late clinical-stage products that address significant unmet need in oncology and rare diseases.

See Yourself at TelixThe Senior Manager, Clinical Quality will be part of a Telix team responsible for establishing, implementing and maintaining appropriate quality assurance processes and documented procedures to ensure that clinical trials are conducted and data are generated, recorded and reported in compliance with the protocol, GCP and the applicable regulatory requirement(s). The Senior Manager, Clinical Quality will be responsible for planning, conducting and reporting audits and assessments of Good Clinical Practices (GCPs) Good Pharmacovigilance Practices (GVP), and Good Clinical Laboratory Practices (GCLPs) vendors, clinical investigator sites, laboratories, databases, essential documents, systems, processes and procedures. This position will be dedicated to providing quality oversight and compliance support to Telix's early and late-stage assets.

Key Accountabilities:

• Plan, arrange, schedule and conduct audits and assessments to ensure compliance with Good Clinical Practices (GCPs) Good Pharmacovigilance Practices (GVP), and Good Clinical Laboratory Practices (GCLPs).
• Ensure accurate audit documentation from audits of Clinical Investigator Sites, CROs, supporting laboratories, monitoring organizations and other vendors by writing audit plans, audit agendas and audit reports as well as tracking audit responses and resulting CAPAs.
• Drive inspection preparation activities for regulatory authority GCP/GCLP/GVP inspections and guide coordination of inspection responses.
• Provide Quality oversight and compliance support for Telix study, program, development and matrix teams by attending meetings, representing Clinical Quality and reviewing essential documents.
• Ensure accurate and timely review, investigation and closure of temperature excursions, product complaints and clinical trial related investigations.
• Review critical processes and procedures to identify gaps in standards, procedures and technologies that are a risk to clinical trial quality.
• Participate in initiatives related to critical quality processes such as risk management, data management, trial management, and investigational product management.
• Collaborate with the Clinical Operations team to write, revise, and approve appropriate SOPs, Work Instructions and Forms.

Education and Experience:

• Bachelor's degree in Life Sciences or related discipline required; Master's degree
• American Society for Quality (ASQ) Certification in Quality Auditing, Quality Management, Six Sigma Green Belt or Six Sigma Black Belt required.
• 4+ years of experience in Clinical Quality for Manager level and 7+ years in Clinical Quality for Sr. Manager level leading teams in the biotech/pharmaceutical industry
• Experience with FDA, TGA, PMDA, ICH and EMEA guidelines and regulations
• Excellent time management skills and the ability to work with a sense of urgency
• Strong oral and written communication 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

Key Capabilities:

• Commitment to excellence: Take pride in your work and consistently strive for excellence in everything you do
• Results-oriented: Driven to achieve goals and objectives, with a strong focus on delivering measurable results
• Creativity and innovation: Possess a willingness to think outside the box and come up with unique and creative solutions to challenges
• Strong communication skills: Able to communicate effectively with colleagues and stakeholders at all levels, using clear and concise language
• Collaboration: Work effectively as part of a team, actively sharing knowledge and expertise to achieve common goals
• Resilience: Demonstrate the ability to bounce back from setbacks and persevere in the face of challenges
• Inclusive mindset: Demonstrate an understanding and appreciation for diversity, and actively work to create an inclusive environment where everyone feels valued and respected
• Adaptability: Comfortable working in a dynamic environment, able to adjust to changing priorities, and willing to take on new challenges
• Ethical behavior: Act with integrity and demonstrate a commitment to ethical behavior in all interactions with colleagues and stakeholders
• Continuous learning: Show a commitment to ongoing learning and professional development, continually seeking out opportunities to expand your knowledge and skills

At Telix, we believe everyone counts , we strive to be extraordinary , and we pursue our goals with determination and integrity . You will be part of an engaged and supportive group of colleagues who all have a shared purpose: to help people with cancer and rare diseases live longer, better quality lives. Being a Telix employee means being a part of a unique, global, interdisciplinary team working to deliver what's next in precision medicine. We have hybrid and remote employees located all around the world. We offer competitive salaries, annual performance-based bonuses, an equity-based incentive program, generous vacation, paid wellness days and support for learning and development.

Telix Pharmaceuticals is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, and other legally protected characteristics.

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