Senior Manager, Development Quality

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

📋 Description

• Act as a senior technical and operational quality leader within the Development Quality division.

• Provide expert supervision of quality activities related to CDMO/CMO.

• Lead the implementation of quality management system processes.

• Serve as the primary quality liaison with external manufacturing partners.

• Bring extensive radiopharmaceutical GMP knowledge and independent judgment to complex quality challenges.

• Mentor and guide junior quality team members.

• Develop scalable quality processes to support IND-stage program requirements across various country jurisdictions.

⛳️ Requirements

• A BS/BSc or higher in a science-related field is required; an advanced degree is preferred.

• Over 8 years of progressive quality experience in the pharmaceutical, biotechnology, or radiopharmaceutical sectors.

• Required direct radiopharmaceutical quality experience, including knowledge of short half-life manufacturing.

• Proven expertise in independently authoring, reviewing, and approving SOPs.

• Significant experience in independently reviewing and approving batch records produced by CMOs/CDMOs.

• Expert-level proficiency in leading investigations, conducting root cause analyses, and managing CAPA.

• Practical expertise in quality risk management utilizing ICH Q9 frameworks.

• Proven ability to operate as a senior quality representative within matrixed, cross-functional teams.

• Comprehensive understanding of 21 CFR Part 210/211/212, ICH Guidelines, and USP requirements.

• Experience in the radiopharmaceutical industry is required; quality auditing experience is preferred.

• Willingness to travel (approximately up to 20%) for CDMO/CMO audits.

🏝️ Benefits

• Competitive salaries

• Annual performance-based bonuses

• Equity-based incentive program

• Generous vacation

• Paid wellness days

• Support for learning and development