Project Quality Lead II
Project Quality Lead II
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Job Description
When our values align theres no limit to what we can achieve.
At Parexel we all share the same goal - to improve the worlds health. From clinical trials to regulatory consulting and market access every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.
Each of us no matter what we do at Parexel contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally we do it with empathy and were committed to making a difference.
Glendale CA
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.
- 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.
Employment Type
Full-Time
