Overview
LAB – Histologic Technician (HT) 40 hrs/wk, 1st shift Jobs in Findlay, OH at Blanchard Valley Hospital
We are seeking an experienced Senior Manager, R&D Quality Assurance to independently lead Clinical Quality Assurance (CQA) activities for assigned clinical studies. This role will serve as a QA Program Lead, providing oversight to ensure study conduct is compliant with the protocol, Good Clinical Practice (GCP), regulatory requirements, and internal procedures. The position will also lead inspection readiness and audit activities and provide support to various quality and compliance functions.
Key Responsibilities:
Program Lead (PL) Responsibilities
Independently perform the QA Program Lead role as outlined in the Program Lead Plan.
Oversee study compliance with protocols, GCP, SOPs, and regulatory guidance.
Lead or co-lead Investigator Site Audits (ISAs), including planning, execution, reporting, and CAPA follow-up.
Manage and report key study risks, especially for Phase 2 & 3 trials.
Support Quality Event (QE) activities related to sponsor, site, and vendor non-compliance.
Provide guidance to junior QA staff and other Program Leads.
Maintain effective collaboration with cross-functional teams and external partners.
Inspection Readiness
Own and drive inspection readiness for assigned studies.
Create, assign, and track inspection readiness workstreams across departments.
Support or lead regulatory inspection preparations (FDA, EMA, PMDA, etc.).
Lead Site Inspection Readiness Training visits and manage inspection-related CAPAs.
Serve as front room/backroom support during inspections and advise on team assignments.
Audit and Vendor Oversight
Support QA Vendor Quality Oversight (VQO) audit teams.
Provide input into vendor audit scope and review CAPA responses.
Co-audit vendor audits, as needed.
Process Quality Excellence (PQE) Support
Participate in and lead process audits and multi-study quality events.
Contribute to process improvements, SOP/WI updates, and regulatory intelligence reviews.
Requirements
Required Qualifications:
Bachelor’s degree in a life science or health-related discipline required.
Master’s degree preferred.
Minimum 7 years of GCP Quality Assurance or related clinical trial oversight experience.
Demonstrated experience in:
Late-phase clinical trial oversight
Audit leadership
Inspection readiness and Health Authority inspections
Quality event and CAPA management
Cross-functional study team collaboration
Preferred Qualifications:
Experience across clinical phases (1–3)
Familiarity with outsourced audit management
Knowledge of Clinical Supply Chain, Clinical Operations, Regulatory Affairs, Drug Safety, and Data Management
In-depth understanding of GCP regulations and global agency guidance (FDA, EMA, PMDA, etc.)
Strong leadership, communication, and project management skills
Comfortable with hybrid work schedules and occasional travel (10–25%)
Benefits
Contract Terms:
Type: 6-Month Contract
Schedule: Hybrid (Remote + Onsite as needed)
Interview Process: 2 rounds
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Title: LAB – Histologic Technician (HT) 40 hrs/wk, 1st shift
Company: Blanchard Valley Hospital
Location: Findlay, OH
