Darrell Morrow, Pmp Email & Phone Number

Cambridge, Massachusetts, US

Bagsværd, DK

Watertown, Massachusetts, US

Waltham, Massachusetts, US

Cambridge, MA, US

Identify and implement Acceleron's Strategic Quality Objectives. Provide strategic leadership for GxP policies and continuous improvements. Direct QA and QC activities to ensure compliance for preclinical and early-phase drug candidates as well as preclinical and clinical activities. Work cross-functionally to understand needs of other groups and ensure QA.

Cambridge, MA, US

Responsible for GxP QA support of pre-clinical, Phase 1 and Phase 2 drugs. Ensured CMC facility and staff were prepared for Qualified Person (QP) inspection and accompanied QP on additional inspections of CMOs. The role included hands-on participation in lot release, audits, investigations, customer complaints, Quality Agreements, computerized system.

Paris, France, FR

Jan 2011 - December 2011: R&D QA Director - Cambridge Discovery North America Center of Excellence. Implementing sanofi pasteur Good Research Practice requirements in collaboration with personnel from multiple functional areas and sites. Sept 2008 - Dec 2010: Head of QA for the Cambridge Massachusetts site, supporting R&D. The scope of support included.

Held this position from September 2006 - responsible for GxP QA for Massachusetts R&D and Operations. This role followed positions of increasing responsibility for QA at Acambis.

This job included lot release of commercially licensed product, deviation handling, internal auditing, and continuous improvement. Performed manufacturing activities as a back-up for Epicel product assembly, and received training in Carticel manufacturing process. Prior to this role, while also at GTR, performed Document Control functions.