Overview
Senior Quality Assurance Manager Jobs in Pennsylvania, United States at RBW Consulting
Title: Senior Quality Assurance Manager
Company: RBW Consulting
Location: Pennsylvania, United States
Job Title: Senior Validation Manager, Quality Assurance
Location: On site, PA
Key Responsibilities
Oversee QA validation activities including review of qualification/validation protocols and reports.
Evaluate GMP documentation, change controls, and deviations related to validation.
Supervise and qualify QA specialists; ensure compliance with data integrity and regulatory requirements.
Serve as QA subject matter expert during audits and inspections.
Collaborate with other QA teams including Quality Systems and shop-floor QA support.
Qualifications
12+ years of experience in biopharma or pharmaceuticals with a focus on QA and validation.
Strong knowledge of FDA/EMA regulations, cGMP, and ICH guidelines.
Degree in Biochemistry or related scientific field (BS/MS/PhD).
Preferred experience with systems like SAP, TrackWise, and MasterControl.
Familiarity with cleanrooms, aseptic processes, and facility qualification.
Prior management experience preferred.
Flexibility to support other U.S. sites remotely or on-site as needed.
