Andrew Downing
Senior Director - External Manufacturing Quality Assurance at Elanco | Bourne End, England, United Kingdom
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Andrew Downing serves as the Director of External Manufacturing Relationships at Ipsen, where he leverages over 25 years of extensive experience in the pharmaceutical industry to drive quality and efficiency across the supply chain. His role is pivotal in ensuring that Ipsen's partnerships with Contract Development and Manufacturing Organizations (CDMOs) are not only robust but also aligned with the highest standards of quality and regulatory compliance. Andrew's expertise spans a diverse range of dosage forms, including solid, semi-solid, sterile, and liquid formulations, as well as investigational medicinal products and radiopharmaceuticals.
In his current position, Andrew is responsible for the risk-based oversight of contractual relationships with key partners, meticulously managing all aspects of quality, technical specifications, regulatory requirements, supply chain logistics, distribution, and cost management. His proactive, problem-solving approach ensures that challenges are addressed swiftly, facilitating the timely delivery of critical medicines to patients suffering from rare diseases globally. Andrew’s end-to-end supply chain accountability encompasses everything from product launch to commercialization, underscoring his commitment to patient-centric outcomes.
His comprehensive skill set includes quality systems management, quality auditing, and adherence to Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP). He is well-versed in regulatory frameworks such as FDA guidelines and U.S. Title 21 CFR Part 11 regulations, which are crucial for maintaining compliance in a highly regulated industry. Andrew's ability to navigate complex supply chain dynamics while fostering strong relationships with external partners positions him as a key leader in Ipsen's mission to deliver innovative therapies to patients in need.
Senior Director - External Manufacturing Quality Assurance at Elanco in August 2024 to Present
Director of External Manufacturing Relationships at Ipsen in December 2021 to August 2024
Director of Quality - External Manufacturing Operations at Ipsen in April 2017 to December 2021
Director of Quality at Patheon in February 2016 to February 2017
Associate Director, Global Quality Assurance - EMEA at Astellas Pharma Europe in November 2012 to January 2016
Qualified Person at GE Healthcare in February 2012 to November 2012
Head of Technical & Engineering at Martindale Pharma in December 2010 to January 2012
Qualified Person at Martindale Pharma in April 2008 to January 2012
Deputy QA Manager at Forest Laboratories in January 2005 to January 2008
Senior QA Specialist at Merck Sharp & Dohme in January 2002 to January 2004
Senior Quality Auditor at Abbott Laboratories in January 1996 to January 2002
Medical Device Technician at Abbott Laboratories in January 1995 to January 1996
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Quality Systems
Quality Auditing
Medical Devices
Engineering
GMP
QP
Regulatory Affairs
Validation
Quality Management
Quality System
Pharmaceutical Industry
CAPA
Sop
Change Control
21 CFR Part 11
Quality Assurance
FDA
Regulatory Requirements
GLP
GxP
V&V
Aseptic Processing
Technology Transfer
Pharmaceutics
HPLC
Regulatory Submissions
Cleaning Validation
Computer System Validation
Trackwise
ISO 13485
Sterilization
Biopharmaceuticals
Clinical Trials
Analytical Chemistry
Quality Control
LIMS
SOP
U.S. Food and Drug Administration (FDA)
U.S. Title 21 CFR Part 11 Regulation
Standard Operating Procedure (SOP)
Good Laboratory Practice (GLP)
Corrective and Preventive Action (CAPA)
Verification and Validation (V&V)
FDA GMP
MHRA
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Discover more about ElancoWhat is Andrew Downing email address?
Email Andrew Downing at [email protected]. This email is the most updated Andrew Downing email found in 2026.
What is Andrew Downing phone number?
Andrew Downing phone number is +19089639334.
How to contact Andrew Downing?
To contact Andrew Downing send an email to [email protected]. If you want to call Andrew Downing try calling on +19089639334. (updated on November 05, 2024)
What company does Andrew Downing work for?
Andrew Downing works for Elanco
What is Andrew Downing's role at Elanco?
Andrew Downing is Senior Director - External Manufacturing Quality Assurance
What industry does Andrew Downing work in?
Andrew Downing works in the Pharmaceutical Manufacturing industry.
Andrew Downing Email Addresses
Andrew Downing Phone Numbers
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