Ms. Audrey Schupp has been in the pharmaceutical industry for over twenty years. She began her career in the Quality Control Microbiology department of a life sciences company under consent decree. Within a year of her employment, she was chosen to be a team member of a newly created Quality Assurance department dedicated to working closely with Operations in order to elevate company Quality standards and extract the company from the consent decree. This unique opportunity allowed Audrey to witness how Quality and Operations could be structured to affect real change and allowed her to participate in the development of Quality Systems aimed at building Quality principles into the manufacturing and facility operations. Harmonizing Quality and Manufacturing has been her guiding principle throughout her career.
Audrey Schupp has been in Quality and Manufacturing roles in both traditional and virtual pharmaceutical companies. Audrey has managed vendor relationships for product launches, product relaunches or rebranding, technical transfers, and highly challenging routine production environments. She has worked directly in technical roles as the Subject Matter Expert for liquid, powder, ointment, ampoule, pre-filled syringe, and lyophilized sterile/aseptic products; nasal sprays; transdermal and topical products; ophthalmic products; solid dosage forms; medical devices; and combination products. She has lead project teams through complicated technical transfer programs, Quality Systems remediation programs, and Quality by Design product strategies. She is a skilled CMC submission technical writer (IND, NDA, ANDA, BLA, PAS, CBE-30, CBE-0). She has expertise in due diligence audits, quality audits, and vendor sourcing.
In 2016, Audrey Schupp partnered with Dr. Barbara Berglund to create CMC Turnkey Solutions, LLC. CMC Turnkey Solutions is the premier choice to shepherd pharmaceutical products from innovation through commercialization. CMC Turnkey Solutions works with small, virtual, niche innovative companies to provide regulatory strategy support, submission preparation, CMC Quality and Operations oversight, and supply chain management to ensure product is developed and manufactured under Quality First principles.