Senior Manager, Clinical Quality

This is a fully remote position, open to applicants in United States.

📋 Description

• Develop, implement, and sustain quality assurance processes alongside documented procedures for compliant clinical trials and trustworthy clinical data.

• Organize, schedule, and conduct audits and assessments for GCP, GVP, and GCLP.

• Create audit plans, agendas, and reports while tracking audit responses and resulting CAPAs.

• Lead preparation for regulatory authority inspections and coordinate responses to those inspections.

• Offer quality oversight and compliance support to study, program, development, and matrix teams.

• Examine essential documents and participate in relevant team meetings.

• Assess, investigate, and resolve temperature excursions, product complaints, and clinical trial-related inquiries.

• Evaluate critical processes and procedures to identify quality gaps in clinical trials.

• Engage in risk management, data management, trial management, and investigational product management initiatives.

• Collaborate with Clinical Operations to draft, amend, and validate SOPs, Work Instructions, and Forms.

⛳️ Requirements

• A Bachelor’s degree in Life Sciences or a related field is required.

• Certification in Quality Auditing, Quality Management, Six Sigma Green Belt, or Six Sigma Black Belt from the American Society for Quality (ASQ) is required.

• Over 7 years of experience in Clinical Quality at the Senior Manager level, leading teams within the biotech/pharmaceutical sector.

• Familiarity with FDA, TGA, PMDA, ICH, and EMEA guidelines and regulations.

• Exceptional time management abilities and a strong sense of urgency.

• Proficient in oral and written communication, with the capability to present information clearly and logically.

• Skillful in prioritizing and managing multiple projects to meet critical deadlines.

• Keen attention to detail and proficient problem-solving skills.

🏝️ Benefits

• Competitive salaries.

• Annual performance-based bonuses.

• Equity-based incentive program.

• Generous vacation policy.

• Paid wellness days.

• Support for learning and development initiatives.

• Hybrid and remote work arrangements available for Telix employees globally.