Senior Manager, Commercial Product Quality – TLX250-CDx, TLX101-CDx

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

📋 Description

• Plays a crucial role in maintaining the highest levels of product quality and compliance within our commercial operations.

• Responsible for managing and optimizing quality management systems.

• Leading continuous improvement efforts.

• Supervising contract manufacturing organizations.

• Collaborating with cross-functional teams that focus on TLX250-CDx and TLX101-CDx (18F-FET) as they progress through the commercialization process.

⛳️ Requirements

• A Bachelor’s degree in a relevant scientific or engineering discipline is required; an advanced degree is preferred.

• Over 8 years of experience in quality within the pharmaceutical or biotechnology sector.

• Familiarity with statistical techniques and methodologies applicable to quality assurance.

• Demonstrated expertise in developing and managing quality management systems within a regulated environment.

• Strong understanding of global regulatory standards, including FDA and EMA regulations.

• Exceptional leadership and communication abilities, with a capacity to influence and collaborate across various departments.

• Proven track record in driving continuous improvement initiatives and achieving measurable outcomes.

• Experience in risk management, root cause analysis, and CAPA (Corrective and Preventive Action) processes.

🏝️ Benefits

• Competitive salaries.

• Annual performance-based bonuses.

• Equity-based incentive program.

• Generous vacation policy.

• Paid wellness days.

• Support for personal learning and development.