Senior Manager, GCP Compliance, R&D QAApply Now
Location: Boston, Massachusetts 02210
Employment Type: Contract
Job Description
Contract Length: 6+ months
Job Summary: This person will be responsible for the quality assurance and compliance activities in support Operational Quality Issues Management.
Responsibilities:
Requirements:
Job Summary: This person will be responsible for the quality assurance and compliance activities in support Operational Quality Issues Management.
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.
Requirements:
- 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
- Bachelor’s Degree and 6 years of relevant work experience or a combination of training and experience preferred
Contact
Ovrille Gonsalves
Director of Recruiting & Training
Ovrille is responsible for full lifecycle recruiting for JVT’s clients across several industry verticals. He supports the Contract Recruiting team, and specializes in identifying temp (contractual) and temp-to-perm resources for JVT’s clients.
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