Audrey Schupp

Ms. Audrey Schupp has been in the pharmaceutical industry for 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; solid dosage forms; medical devices; and combination products.  She has led 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 (NDA, ANDA, BLA, PAS, CBE-30, CBE-0).  She has expertise in due diligence audits, quality audits, and vendor sourcing.

In 2014, Audrey Schupp began her own consulting business aimed at assisting pharmaceutical, biotechnology, and medical device companies in achieving their submission goals.  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.

Specialization in project, product, and vendor management, including use of project management tools

  • Capabilities include all stages of product lifecycle management from pilot scale development through commercialization, including product launches/relaunches/rebranding, technical transfers, and routine production
  • Quality Management Systems support including program development, SOP/Policy/Master Records development, non-conformance and CAPA support, remediation programs, and Quality by Design product strategies.
  • Temporary, short-term staffing capabilities in management level Operations, Supply Chain, Quality Control, and Quality Assurance positions
  • Subject Matter Expert for liquid, powder, ointment, ampoule, pre-filled syringe, lyophilized sterile/aseptic products; nasal sprays; transdermal and topical products, solid dosage forms, medical devices; and combination products
  • Skilled CMC submission technical writer (NDA, ANDA, BLA, PAS, CBE-30, CBE-0)
  • Expertise in due diligence audits, quality audits, and vendor sourcing
  • Ensure high Quality standards are maintained by practicing best practices and “Right the First Time” policies by adherence to GMP (FDA CFR 210, §211, §820)
  • Negotiate Master Supply/Service Agreements, Quality Assurance Agreements, and Service Estimates
  • Sourcing and due diligence participation for Contract Organizations (including manufacturers, laboratories, packaging operations, distribution)
  • Collaborate with industry and subject matter experts for product design, optimization, and troubleshooting
  • Write and execute performance qualification and process validation activities
  • Utilize project management tools such as detailed timelines, meeting agendas/minutes, action plan tracking/reporting
  • Analyze key performance indicators and statistical trends