Sarah Silvers

Head of Clinical QA

Orca Bio

Nov 2023 - Current (2 years 10 months)

Senior Director, Clinical Quality Assurance

Tenaya Therapeutics

Dec 2022 - Nov 2023 (1 year)

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Senior Director, GCP Quality Assurance

SanBio Inc

Jun 2021 - Jul 2022 (1 year 2 months)

Served as the GCP subject matter expert to cross-functional clinical trial teams to ensure that all quality and regulatory compliance activities were conducted in compliance with GCPs, SOPs and ICH Guidelines. Successfully led the company through their first-ever regulatory inspections (FDA and PMDA) with a result of “no action indicated” for the FDA inspection (PMDA inspection results were pending at time of company reduction in force). Established the strategic direction of the inspection readiness initiative by organizing and preparing documentation for the inspection library, trained/readied SMEs, created process flows, established war room, etc. and served as primary (for FDA) and US-primary (for PMDA) inspection host. Drafted new/

Senior Director, Quality and Vendor Management

Catalyst Clinical Research LLC

Jan 2021 - Jun 2021 (6 months)

Led all quality aspects of clinical trials. Provided internal cross-functional and external customer quality/compliance guidance commensurate with company size/structure and the clinical stage development. Mentored and developed staff, designed and conducted GCP and other quality training. Qualified and oversaw third party GCP service providers and developed and executed internal and external audit plans. Following the merger of Ce3 with Catalyst, single-handedly harmonized the QMS of both companies into a single “best of the best” QMS. Conducted/oversaw/hosted vendor qualification audits which included CROs, EDC providers, bioanalytical labs, pharmacovigilance, phase 1 units, electronic source (eDiaries), cloud providers etc. Designe

Director, GCP Process Control and Compliance

Catalyst Clinical Research LLC

Jan 2017 - Jan 2021 (4 years 1 month)

Conducted quality reviews of Clinical Study Reports and New Drug Applications/Biologic License Applications (including tables, listings, and graphs; safety narratives; etc.). - Detected critical system errors and data integrity concerns. - All efforts have led to the approval of the NDA/BLA submission. Designed, implemented and maintained (including quality oversight of validation and qualification activities) Ce3’s Quality Management System. ClinSuite is a validated electronic document storage and routing system for process and quality related documents and is used to host virtual audits. Authored, implemented, and executed Audit Plans (sponsor, CROs, and clinical sites); management responsibilities for contract auditors. Performed num

Associate Director, GCP Process Control and Compliance

Catalyst Clinical Research LLC

Jan 2013 - Jan 2017 (4 years 1 month)

Implemented and maintained a culture of quality that permeated the entire organization. Created and hosted training sessions to keep Catalyst employees informed of new FDA regulation, guidance, ICH-GCP, quality concepts, and industry standards. Trained all staff to think like auditors; taught and incorporated quality by design into all critical projects/deliverables. Served as primary Quality Control OverSight (QCOS) Evaluator. The QCOS team provided oversight of 4 CROs contracted for two 750+ subject global mega studies. The program ensured quality output from the CROs and study sites as well as adherence to federal and local regulations, ICH-GCP, ALCOA standards, and client expectations. Trained Evaluators to conduct Quality Evalu

Manager, GCP Process Control and Compliance

Catalyst Clinical Research LLC

Jan 2011 - Jan 2013 (2 years 1 month)

Single-handedly established Ce3’s Quality Management System (QMS) from the ground up. Authored SOPs, Policy Statements, Business Practices (BPs), job aids, templates and tools.

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Quality Management Auditor

Purdue Pharma

Sep 2008 - Jan 2011 (2 years 5 months)

Hired for command of medical terminology and of the application of scientific/medical and clinical concepts used to conduct Phase I-IV clinical trials, prepared the organization for an NDA submission by performing retrospective audits of all studies submitted. The effort spanned generations of regulations, SOPs/governance, etc. Key contributor to FDA submission & inspection readiness project which led to NDA approval after an initial rejection several years prior. Uncovered critical compliance gaps and unearthed important documents that were not known to have existed. Audited 30+ studies, 100,000+ essential documents Provided key support for FDA site and sponsor audits (conducted preemptive on-site audits, provided training, suppli

Clinical Research Associate

POZEN

Jan 2008 - May 2008 (5 months)

Accountable for successful management of programs by ensuring on-time and on-budget study activities while upholding high quality standards and compliance with applicable regulations and ICH standards. The inspired role took on both project and vendor management as well as CRA responsibilities. Set the precedent for the company by establishing policy/requirements for field force operations, maintenance of study documentation, quality of work, etc. Secured compliance with clinical trial registry requirements.

Clinical Trial Associate I/II

Amgen Inc

Mar 2004 - Oct 2007 (3 years 8 months)

Provided in-house CRA support for phase I-III trials. Daily tasks included site relations; tracking, reporting, and managing review/approval of clinical documents; and managing clinical supplies and study drug. Established the company’s first co-monitoring mentorship program then became the first participant. Provided a pathway to internally develop staff, greatly contributing to a more positive and fulfilling company culture. Consulted on Amgen’s first pivotal, global, outsourced mega study; collaborated with international colleagues to develop and realize key workflows; presented at global kick-off meeting. Developed and executed innovative feasibility/site recruitment techniques and processes to significantly improve study start-

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