Senior Quality Assurance Consultant
Ms. Fasso has worked in industry holding various Quality Control and Quality Assurance roles for over 30 years. She received her BS in Chemistry at Drexel University before going on to earn her M.S in Regulatory Affairs/Quality Assurance at Temple University. Susan has held increasing roles of responsibility in Quality Assurance throughout her career at Wyeth, Flour Daniel, GW Labs Iroko and GPC Biotech amongst others.
Susan provides our clients with a depth of relevant experience that she readily shares. Susan is routinely asked to advise on phase appropriate solutions to a client’s needs. This includes a global understanding of compliance standards. In this capacity Susan has provided our clients with comprehensive gap analysis reports that they can then go on and use as resource justifications or to map out their Quality Systems.
Susan has planned and performed PAI and BIMO Inspection activities, provided input to filing IND’s, CTA’s, and MA submissions for small molecule and biologics products, managed lot release activities on behalf of clients, as well as managed client vendor audit responsibilities. Susan can work independently on behalf of a client or within any existing infrastructure a client may have in place which makes her an essential member of our team.
- Supplier Audits
- QA SOP Development
- Risk Based Approach
- FDA 483 Remediation
- CMO/CRO Selection
- Internal QA Management
- Biologic Experience
- Quality Compliance
- Global Markets
- ASQ Quality Auditor Certified