Senior Associate, Quality Systems

Role: Support GXP activities related to Quality Systems, focusing on document management, compliance, and audit readiness within a biopharma manufacturing environment. Responsibilities include maintaining controlled documents, managing electronic systems (MasterControl, VEEVA), and supporting quality lifecycle activities such as revision, approval, and archival. The position involves collaborating with cross-functional departments, assisting in internal audits, and supporting continuous improvement projects to optimize quality system performance. Requirements: Bachelor's degree or equivalent, minimum 4 years' experience in regulated manufacturing or quality roles, proficient in MS Office, and experienced with electronic document management systems (MasterControl, VEEVA preferred). Skills in organization, communication, and issue resolution are essential. Preferred qualifications include familiarity with GxP, GDP, and audit processes. High-value specifics: supporting quality systems in a cGMP biopharma setting, emphasizing document control, audit preparedness, and regulatory compliance, with a focus on manufacturing documentation and quality record management. The role supports multiple sites and internal/external customer needs, with a flexible, detail-oriented approach.