"Alerted.org

Glendale, CA (Hybrid role - office & remote based)

The Project Quality & Risk Lead II is responsible for leading quality and risk oversight for clinical trials within the Early Phase Clinical Units. This role ensures first-time quality, robust risk and issue management and inspection readiness by collaborating with operational teams and clients. Key duties include facilitating risk assessments, managing quality events, supporting audits and inspections, and providing expert guidance on regulatory compliance. The position requires strong analytical, communication, and problem-solving skills, along with experience in clinical research, quality management, and ICH-GCP standards. It also involves mentoring new team members and contributing to continuous improvement initiatives

Key Responsibilities:

Client Liaison & Communication

+ Act as the main contact for client quality representatives.

+ Respond to urgent quality requests and facilitate quality-to-quality meetings.

Risk Management

+ Lead risk identification and mitigation processes.

+ Develop and assess risk mitigation strategies and quality tolerance limits.

Quality Event Management

+ Triage and classify quality issues.

+ Facilitate root cause analysis (RCA) and corrective/preventive actions (CAPA).

Inspection Readiness

+ Conduct Inspection Readiness Checks (IRCs).

+ Support audit/inspection preparation and response.

Quality Consultancy

+ Provide real-time quality advice.

+ Review SOP deviations and consult with SMEs

Documentation & Storyboards

+ Ensure inspection-ready documentation.

+ Oversee storyboard development and updates.

Continuous Improvement

+ Identify and propose process improvements.

+ Participate in quality system enhancements.

Mentorship

+ Mentor and train new PQRLs.

Skills Required:

+ Strong communication and interpersonal skills.

+ GCP experience highly preferred

+ Critical thinking and analytical abilities.

+ Experience with root cause analysis tools (e.g., 5 Whys, Fishbone).

+ Ability to manage workload independently and in a matrix environment.

Education:

+ Educated to the degree level (biological science, pharma or health related discipline) or relevant clinical/quality equivalent

EEO Disclaimer

Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.