Manager, GMP Quality

Duties and Responsibilities

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

Requirements and Qualifications

• 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 Qualifications

• 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.).

Pay

Pay Rate: $80 - $90 per hour

Schedule

Hybrid Role