Quality Lead

Integrated Resources Inc.; Groton (CT); On-site; USD 85,000 - 120,000; Full time

Job summary

A premier staffing firm seeks a professional to lead the management of Significant Quality Events within DevOps. The role requires collaboration with compliance teams, effective project management, and extensive knowledge in quality and regulatory processes. Candidates should be adept in leading initiatives and engaging with diverse stakeholders.

Qualifications

• In-depth knowledge of quality audit, quality management, inspection readiness, compliance assessments.
• Experience leading global initiatives or project teams, understanding clinical trials.
• Strong influencing skills and ability to manage a demanding workload.

Responsibilities

• Collaborate with CTPQ/GCP Compliance Management within DevOps.
• Lead the Significant Quality Event team, managing investigations and documentation.
• Interact with diverse internal stakeholders and ensure timely delivery of actions.

Skills

Quality management

Communication

Project coordination

Stakeholder engagement

Root Cause Analysis

Education

Degree in drug development or business

Tools

Quality audit

Regulatory requirements

Job description

Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-state area's most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since 1996. Our mission centers on delivering top-quality talent, the first time and every time. We provide resources in four specialty areas: Information Technology (IT), Clinical Research, Rehabilitation Therapy, and Nursing.

Job Description

- Collaborate with and support CTPQ/GCP Compliance Management within DevOps, focusing on managing Significant Quality Events.

- Lead the Significant Quality Event team, coordinating activities such as immediate action, investigation/RCA, corrective and preventive actions, and documentation within the appropriate database.

- Share learnings across the portfolio to other impacted study teams.

- Interact with a diverse range of internal stakeholders.

- Effectively manage projects, lead Significant Quality Event and Investigation/RCA teams, and ensure timely delivery of actions.

- Possess knowledge of GCP, clinical trial processes and systems, CAPA, quality issues, regulatory requirements, quality management, Root Cause Analysis, and inspection readiness.

- Manage Significant Quality Events, including forming teams, arranging meetings, documenting outcomes, facilitating investigations, and ensuring follow-up actions are completed and documented properly.

Qualifications

- Degree in a discipline related to drug development or business.

- In-depth knowledge of quality audit, quality management, inspection readiness, compliance assessments, CAPA management, continuous improvement, and root cause analysis.

- Knowledge of clinical trial operational processes, including study management, data management, reporting, and project management.

- Understanding of clinical trials and ability to work effectively with internal and external partners.

- Experience leading global initiatives or project teams, with awareness of regulatory requirements across different countries.

- Knowledge of international quality standards and requirements.

- Strong influencing and communication skills, capable of engaging diverse stakeholder groups.

- Proven achievement in personal and team goal delivery.

- Ability to prioritize and manage a demanding workload independently.

- Familiarity with ICH GCP and regulatory obligations.

- Skills in quality and compliance management, project coordination, CI/RCA.

- Ability to lead cross-line global initiatives and root cause analyses for process improvements.