Quality Issue Lead
Not Disclosed•Full-TimeRemote
location_on2925, H Street, Marshall School, East Sacramento, Sacramento, Sacramento County, California, 95816, United States
About the Role
Parexel FSP is seeking an Issue Lead to drive the management of Quality Events (QE) across the US or Canada. This role serves as a critical control point in our quality ecosystem, ensuring that investigations are conducted thoroughly, efficiently, and in strict compliance with Good Clinical Practice (GCP) and regulatory requirements.
In this position, you will act as the primary owner of the investigation lifecycle. Your day-to-day involves triaging submitted cases to determine if they meet the QE threshold, assessing the need for expedited reporting to senior management or regulatory authorities, and managing confirmed events from initial assessment through root cause analysis. You will leverage data to evaluate team performance and implement targeted interventions where necessary.
Beyond individual case management, you will play a key role in process improvement. You will collaborate with PFE Digital to develop technology solutions, create guidance documents, and lead training initiatives to elevate the capabilities of the broader investigation team. Your work ensures that CAPA plans are not only implemented but are effective in mitigating risk and preventing recurrence.
Hiring Process
Qualified candidates will be considered for this remote opportunity. Please note that this role requires a strong background in pharmaceutical quality and regulatory compliance.
Equal Opportunity Employer
Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, including race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.
Work location
Work model: Remote
2925, H Street, Marshall School, East Sacramento, Sacramento, Sacramento County, California, 95816, United States
Sacramento, California
Key Responsibilities
- check_circleConduct thorough GCP investigations including root cause and gap analysis for quality events
Similar Job Opportunities
Skills, education and keywords
Skills: GCP, GXP, Root Cause Analysis, Gap Analysis, Due Diligence, Sop, Capa, Lean Six Sigma.
Education: Master's or MBA preferred with 6+ years experience.
Frequently asked questions about Quality Issue Lead at Parexel
What does a Quality Issue Lead at Parexel do?expand_more
A Quality Issue Lead at Parexel is responsible for the following: Conduct thorough GCP investigations including root cause and gap analysis for quality events; Initiate escalation of critical quality events to senior management and regulatory authorities; Develop and manage CAPA plans to track effectiveness of mitigation actions for audits and inspections; and Track and ensure implementation of risk mitigations while evaluating potential business impacts.
What are the requirements for this Quality Issue Lead role?expand_more
Parexel is looking for candidates who meet the following requirements: BS degree with 7+ years experience or MS/MBA with 6+ years experience; Minimum 5 years pharmaceutical experience; Regulatory inspection experience; Process and system management experience; Detailed knowledge of clinical trial processes; and Knowledge of GCP requirements, SOPs, and regulations.
Where is the Quality Issue Lead role at Parexel located?expand_more
Quality Issue Lead at Parexel is based in 2925, H Street, Marshall School, East Sacramento, Sacramento, Sacramento County, California, 95816, United States. This is a remote role.