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Shauna Franklin

Sr. Global Manager, Quality Systems

Work experience


Sr. Global Manager, Quality Systems

Astellas Pharmaceuticals

Achievements include: Execution of the internal audit program.  Conducted CAPA issuance and management. 


Sr. Manager, Quality Systems

Sysmex Inostics

Achievements include: Oversight of the In-Vitro Diagnostic product lifecycle for a companion diagnostic offering, including the achievement of CE marking. Managed processes between sites in the US and Germany. Assisted in successful certification to ISO 13485.


Sr. Electronic Data Quality Assurance Project Manager, Program Manager, Quality Systems

Takeda Development Center Americas

Achievements include: Ensured compliance to 21 CFR Part 11, GMP requirements, GCP requirements and system validation, with particular focus on pharmaceutical supply chain. Responsible for validation oversight in emerging markets, including Mexico, and supporting global adherence to Takeda's computerized system validation standard. Managed full-cycle quality system waivers and deviations pertaining to GCP requirements, successfully drove overdue CAPAs to zero, facilitated quality investigations focusing on root cause analysis and prevention of reocurrence, wrote quality system SOPs, effectively executed the internal audit program, and coordinated multiple FDA inspections. Experienced in collaboration and facilitation of cross-functional groups to proactively generate results ahead of deadlines.


Quality Engineer-Imaging, Compliance Leader - North America

GE Healthcare IT

Achievements include: Drove compliance to 21 CFR 820 Design Controls for imaging software, including Radiology Information Systems(RIS) and Cardiovascular product lines. Remotely managed programs in Germany, Finland and several sites within the United States. Responsible for products from concept to end of life. Performed design reviews, program audits and mitigated risks for product families. Quality System rollout including training and integration of acquired sites. Participated in GE Healthcare corporate procedure updates, encompassing ISO 13485 and GMP standards. Responsible for device and non-device activities at a dozen sites across Canada and the United States. 



Protocol Link/CMAC Consultancy

Achievements include: Establishment of quality systems at a medical device start-up, IQ/OQ of clean room equipment at a pharmaceutical manufacturing company, and integration of multiple quality systems at an established pharmaceutical company/third-party manufacturer.


Document Control Specialist

Triad Group, Inc

Achievements include: Creation and routing of quality system documentation and product specifications in manufacturing facility. Maintained training files for full-time staff and contract employees. Performed batch record issuance and yield calculations. Supported a successful FDA inspection.


Software Quality Engineer

Esterline AVISTA

Achievements include: Audited compliance and reviewed verification testing/documentation for DO-178B Level A and B avionic software programs and validation results of medical device software. Assisted company in certifying to ISO 9001. Performed company-wide and new-hire training on approved quality system documentation.



M.Sc; Quality Assurance and Regulatory Science

Northwestern University

B.Sc; Broadcast Technology Management (Communications)

University of Wisconsin-Platteville


Mar 2007Jun 2019

Certified Biomedical Auditor

Jun 2007Jun 2019

Certified Software Quality Engineer

Oct 2009Jun 2019

Certified Manager of Quality/Organizational Excellence