Edward Bowe Email & Phone Number

Responsibilities included strategic planning and management of Supplier activities of all GXP vendors. Management of audit program including both internal and vendor audits against GMP /GCP /GLP standards, FDA/EMA/I CH requirements, and other regulatory standards. Audit of GMP/GCP suppliers including contractor manufacturer/packagers, analytical laboratory, medical device manufacturer, clinical research organizations, clinical sites, and internal Bellus Health QMS

Lexington, Ky, Us

Assessment, development and implementation of clinical phase appropriate Quality System and processes at existing Commercial cGMP drug manufacturing plant. New processes developed for SAP system to provide inventory control of phase specific starting materials. Processes developed for other areas including Clinical Master Batch record development, Clinical production record issuance, and change control.

Conducted various audits of sterile/ non sterile cGMP facilities audit including Data Integrity assessment. Conduct assessment of Quality systems and provided long term solutions, recommendations, and corrective/preventive actions to senior management to eliminate potential inspection observations and ensure an inspection ready facility status.

Nottingham, Nottinghamshire, Gb

Nottingham, Nottinghamshire, Gb

Nottingham, Nottinghamshire, Gb

San Diego, Ca, Us

Master Of Business Administration (Mba), Operations Management And Supervision And Finance

Bachelor Of Science (Bs), Biology, General