Associate Director, GCP Operational Quality (Hybrid)
Vertex Pharmaceuticals
- Boston, MA
- Permanent
- Full-time
- Assist in the continuous improvement of the Issue Management process- handling of QEs, trending and updating processes.
- May manage or assist in (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.
- Assemble Event Action Committees (EACs) as required as well as convene Quality Review Board (QRB) meetings and provide support (e.g., agendas, minutes) as necessary
- Utilize quality tools and techniques (5 why) to support or perform and document full root cause investigations, to evaluate and resolve quality issues, and to enhance continuous improvement.
- May assist in tracking of event completion in expected timeframes and monitor quality of investigation writing.
- May create investigation and deviation records in VEEQMS.
- Communicates proactively with internal and external partners and management.
- Expert in the risk-based approach to quality events, and using data to inform trends and next steps in continuous improvement process.
- Generates Metrics / KPIs, Dashboards and Reports, as requested.
- Participate in inspection readiness and support activities
- May assist with onboarding and ongoing training team members, and may manage direct reports, as needed.
- Assist in additional Quality Assurance initiatives as applicable, including inspection, audit activities
- 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 GCP quality management experience
- Strong communication, problem solving and critical thinking skills
- Knowledge of overall issue management processes, risk based approaches, and best practices
- Experience in quality analytics and using data to make decisions and identify trends
- Experience in inspections and audits
- Bachelor’s Degree and 10 years of relevant work experience or a combination of training and experience