Overview
Orlando attorney Jobs in Florida at Berger Singerman
GENERAL POSITION SUMMARY:
The Sr. Manager, GCP Compliance is responsible for the quality assurance and compliance activities in support of Operational Quality Issues Management.
This role will act as a primary Quality Event manager for GCP related events. This individual will work closely with Quality Leads and Study team members and will demonstrate
RESPONSIBILITIES:
Manage (internal and external) GCP Quality Events including, but not limited to investigations, CAPAs, Root Cause Analysis, Effectiveness Checks).
Perform initial triage of event criticality working with operational Quality or Program Leads and other Subject Matter Experts, as needed.
Escalate critical and major findings to Quality Management and monitor key performance indicators.
Utilize quality tools and techniques to support or perform and document full root cause investigations, to evaluate and resolve quality issues, and to enhance continuous improvement via corrective and preventive actions.
May supervise day to day execution for Investigator Coordinator (IC) activities and/or stand in as back-up for this role in triaging events in expected timeframes.
Create investigation and deviation records in Veeva VeeQMS.
Communicates proactively with internal and external partners and management, as needed.
Collaborate with Quality Lead and Program Lead functions as well as the business study team contacts.
May update risk tables to support Integrated Risk Governance Team meetings.
Generates Metrics / KPIs, Dashboards and Reports, as requested. Assist in additional Quality Assurance initiatives as applicable.
Participate in inspection readiness and support activities. Participate in process improvement initiatives related to Issue Management.
Maintains files and documentation, such that they are readily available and easily retrievable. May assist with onboarding and training of team members.
REQUIRED KNOWLEDGE, SKILLS, AND COMPETENCIES
Experience successfully leading quality event investigations, Root Cause Analysis, and CAPA.
Knowledge of current GCP industry trends and ability to use the latest technologies.
Highly organized with strong planning capabilities.
Compliance and quality management experience (across multiple GxP areas) preferred.
Strong communication, problem solving and critical thinking skills.
Ability to work under minimal supervision.
Experience with quality management applications such as Veeva preferred.
Job Type: Contract
Pay: $60.28 – $70.00 per hour
Benefits:
401(k)
Dental insurance
Health insurance
Paid time off
Vision insurance
Schedule:
8 hour shift
Experience:
• Manage (internal and external) GCP Quality Events: 6 years (Required)
investigations, CAPAs, Root Cause Analysis: 6 years (Required)
Veeva VeeQMS: 4 years (Required)
GCP industry trends: 4 years (Required)
Work Location: Remote
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Title: Orlando attorney
Company: Berger Singerman
Location: Florida
