Note: The job is a remote job and is open to candidates in USA. Telix Pharmaceuticals is hiring a Senior Manager, Clinical Quality to establish and maintain quality assurance processes for clinical trials. The role provides quality oversight and compliance support for clinical-stage programs and plans and conducts GCP, GVP, and GCLP audits and assessments.
Responsibilities
- 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
Skills
- Bachelor's degree in Life Sciences or related discipline required
- American Society for Quality (ASQ) Certification in Quality Auditing, Quality Management, Six Sigma Green Belt or Six Sigma Black Belt required
- 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
- 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
- Master's degree
Benefits
- Annual performance-based bonuses
- An equity-based incentive program
- Generous vacation
- Paid wellness days
- Support for learning and development
- Hybrid and remote work arrangements
Company Overview