The Manager, Global Product Quality oversees quality and regulatory compliance for controlled substances throughout the product lifecycle, ensuring adherence to GMP, CGMP, and global regulations, including DEA standards.
They collaborate with R&D, Supply Chain, and Manufacturing teams to ensure proper handling, storage, and distribution, and support inspections and audits.
The role involves developing SOPs, managing quality systems, analyzing compliance data, and providing training on regulations and best practices.
Qualifications include a Bachelor's in a related field, 5-7 years in regulated industries, and experience with FDA/ICH/USP standards, quality systems, and controlled substance regulations.
Preferred skills include electronic QMS experience, DEA compliance certification, and expertise in warehousing/distribution controls.
Core competencies focus on accountability, strategic thinking, communication, collaboration, and professional development.
Salary ranges from $107,718 to $161,000 plus incentives.