Press Releases > Grisel Pierrez Named Director of Quality at Aphena's Whippany, N.J., Facility
Grisel Pierrez Named Director of Quality at Aphena's Whippany, N.J., Facility
PHILADELPHIA, Pa., July 23, 2012 - Philadelphia-based Aphena Pharma Solutions Inc., a leading pharmaceutical packaging provider in the U.S., is pleased to announce that Grisel Pierrez has joined its Quality Leadership Team as Director of Quality and Regulatory Affairs for Aphena's Whippany, N.J., packaging facility.
Pierrez comes to Aphena from GlaxoSmithKline (GSK), where she served as the Group Leader to the Product Quality Managers in Global External Supply. In that role, she was responsible for the management of third-party contractors based in North America and the European Union covering NDAs, OTC monograph drugs, medical devices, dietary supplements, cosmetics and foods.
Pierrez is well-versed in the US FDA Quality Management System (QMS) process, has worked in the strategic development process, held responsibility for supervising GSK's global product release team and has regulatory experience with inspections from FDA, EMEA, Swissmedic, Japanese Ministry of Health, TGA and ANVISA.
Prior to GSK, Pierrez worked for Hoffman La Roche and Pliva in roles including facilitating FDA inspections and working with international regulatory agencies in Brazil and other nations. Pierrez began her pharmaceutical industry career at Genzyme Biosurgery as a product release analyst and record review auditor.
"We are in a very good position going forward at Whippany with Grisel directing the quality and regulatory aspects of the business as she helps design and build the future for Aphena," said Mary Foster, PharmD, Aphena's Corporate Vice President of Quality and Regulatory Affairs. "She will bring the technical knowledge, communication skills and leadership needed to continue the drive for excellence in compliance and quality."
"I believe that my skill set is very well suited to Aphena's current and future needs, especially as they work to gain approval to manufacture and package products for customers outside the U.S.," said Pierrez. "Furthermore, Aphena is committed to the utmost level of quality assurance and regulatory compliance, and those are areas in which I have a great deal of experience. I'm excited to have a part in taking Aphena to the next level."
Aphena Pharma Solutions Inc. is an industry-leading organization providing turnkey contract packaging, repackaging and manufacturing solutions for the pharmaceutical, OTC, dietary supplements, animal health, health and beauty, consumer health and medical device markets.