Job Details

Manager, GMP Quality

Seeking a Manager, GMP Quality, contractor role who will support GMP QA team. The contractor shall have pharmaceutical quality assurance background to support GMP Operations and provides quality oversight of GMP production at external vendors in addition to processing of all internal & external GxP documentation. This position reports to the Director of GMP Quality.

• Responsible for providing QA oversight of all Quality Control activities including but not limited to test method validations, product specifications, stability programs, etc.

• Collaborate with internal and external stakeholders on deviation investigations, OOX investigations, CAPA plans, change controls, shelf-life extensions and revisions to documentation.

• Collaborate with PDM (CMC), Supply Chain, Analytical Development, and other functions to support GMP QA operations and activities.

• Execution of Quality Systems as Quality SME for Deviations, CAPAs, Change Controls, and other Quality processes.

• In collaboration with the Analytical Development function, provide quality oversight for GMP activities including, approval of Method Validation, Specifications, Release testing, and Stability for Drug Substance and Drug Products.

• Review and approval of CMO documentation (e.g., specification documents, master batch records, label proofs, etc.) as well as review executed batch records, applicable test data (in-process and release), and performing product dispositions.

• Build positive professional relationships and trust to support learning, respect, open communication, collaboration, and teamwork.

Required Skills, Experience and Education:

• A bachelor’s degree in a scientific or technical discipline is required.

• A minimum of 5 years of experience in GMP Quality in the pharmaceutical industry, with experience in late-stage drug product development and validation, is preferable.

• Excellent analytical skills and a strong technical background in small molecule process development, validation, and testing.

• Knowledge of applicable US and Global compliance regulations and industry practices.

Preferred Skills:

• Ability to critically evaluate and troubleshoot complex problems with diligence.

• Strong teamwork, collaboration, and management skills.

• Ability to manage multiple priorities and aggressive timelines.

• Highly responsible, self-motivated professional with enthusiasm and passion for the work.

• Highly proficient with various Microsoft and other computerized systems (e.g., Word, Outlook, Excel, PowerPoint, Visio, etc.).