Job Description:
The Senior Manager, GCP Compliance is responsible for the quality assurance and compliance activities in support 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 Vertex Core Values.
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 finding 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
- Aid with development of corrective and preventive
- May supervise day to day execution for Investigator Coordinator (IC) activities and back up IC for triaging events in expected timeframes.
- Create investigation and deviation records in VEEQMS
- Communicates proactively with internal and external partners and management.
- Collaborate with Quality Lead and Program Lead functions as well as the business contacts.
- May update risk tables to support Integrated Risk Governance Team meetings
- Generates Metrics / KPIs, Dashboards and Reports, as requested
- Participate in inspection readiness and support activities
- Participate in process improvement initiatives related to Issue Management
- Maintains files such that documents are readily available and easily retrievable.
- May assists with onboarding and ongoing training team members
- Assist in additional Quality Assurance initiatives as applicable
REQUIRED KNOWLEDGE, SKILLS, AND COMPETENCIES
- Experience successfully leading event investigations, Root Cause Analysis and CAPA
- Knowledge of current 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
PREFERRED EDUCATION AND EXPERIENCE:
- Bachelor’s Degree and 6 years of relevant work experience or a combination of training and experience
Pay Range:
$75-$85/hr
Requisition Disclaimer:
This job posting is for a temporary role with a third-party agency partner on assignment at Vertex Pharmaceuticals (“Vertex”). The individual selected for this role will be offered the role as an employee of a third- party agency partner; compensation, medical benefits, fringe benefits and other terms and conditions of employment shall be presented by the third-party agency partner upon offer. The pay rate range provided is a reasonable estimate of the anticipated compensation range for this job at the time of posting. The actual pay rate will be based on a number of factors, including skills, competencies, experience, location and/or being pursued and other job-related factors permitted by law. In addition, this role will be eligible for overtime pay, in accordance with federal and state requirements
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If you do not agree with the Atrium Terms and Conditions, you can still complete your application for this position by emailing your resume to our team at tempstaffing@vrtx.com. Please include the job title in the subject of your email.
No C2C or Third-Party Vendors
