Quality Issue Lead - FSP

Parexel • Springfield, IL • 2h ago

Parexel FSP is looking for Issue Leads in the US or Canada !

Job Summary

The Issue Lead will be responsible for driving QE case management, ensuring that investigations are conducted thoroughly within timelines and compliance requirements, overseeing the efficiency of the process by which we conduct GCP investigations, and leveraging data to assess the efficiency / performance of the appropriate teams to perform interventions as needed.

The Issue Lead will also triage submitted cases to ascertain if the Quality Event (QE) threshold has been met and assess cases to determine if they need expedited reporting to senior management and/regulatory authorities and be accountable for managing confirmed Quality Event (QE) case through the investigation process including root cause analysis.

Job Responsibilities:

Quality Event Assessment and Investigation

This individual will be accountable for the review and classification of submitted quality issues to ascertain if the QE threshold has been met. He or she will ensure that each submitted issue is reviewed based on the established criteria, is categorized appropriately, and completed within the required time frame to ensure that events are appropriately qualified enabling expedited investigation where necessary. This individual will also be responsible for completing the necessary documentation in the eQMS system regarding the assessment of the submitted events.

Notification to Management

This individual will be responsible for initiating appropriate escalation of Critical QEs when necessary, ensuring that management is promptly and appropriately informed of quality events. The Issue Lead will be required to assess critical issues and identify these items as appropriate for escalation to leadership via the Notification to Management process.

Root Cause Analysis / Gap Analysis / Due Diligence

Once assigned a qualified event, the Issue Lead will initiate the investigation of the event to confirm the chronology and details of the issue. This individual will also be required to apply a root cause analysis, gap analysis, and / or due diligence investigation to the case. The individual will be trained in the application of an appropriate methodology and will apply it as part of the management of the case. Investigation will include reviewing relevant SOPs and supporting documents to understand what should have happened per our documented process and identifying what did not happen per the process. In addition, the investigation will include review of relevant documentation re: the event and assembling the QE team with appropriate stakeholders (SME's, study team members, etc.) to review and confirm the details of the event

Process Analysis and Improvement

This individual will be responsible for contributing to process development and improvement for case management including contributing to the development of technology (in collaboration with PFE Digital) to enable the process. In addition, the individual, along with Senior Issue Lead peers, will develop and implement guidance documents and training to assist the investigation leads in completing cases to expectations.

CAPA Plan Development and Management

This individual will hold accountability for ongoing monitoring of CAPA completion and tracking of effectiveness for implemented mitigation actions to ensure they are working as expected-for quality events, inspections and audits

Ensure implementation of QE / audit / inspection CAPAs and remediation plans

Track effectiveness checks and report on trends

Risk Mitigation Tracking

Track and ensure implementation of risk mitigations and evaluate potential impacts to business.

QUALIFICATIONS:

BS - 7+ years or equivalent MS/MBA - 6+ years or equivalent

Previous Experience:

Minimum of 5 years of pharmaceutical experience with solid experience in data management, operational aspects, GCP Quality, GxP Quality, and/or regulatory Regulatory inspection experience Process and system management experience Detailed knowledge of clinical trial processes and relationships required Knowledge of GCP requirements and applicable SOPs and regulations Project management, administrative, and technical capabilities are required, as well as effective verbal and Strong background in continuous improvement methodology (i.e., Lean Six Sigma) preferred.

LI-REMOTE

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.

Parexel

Go to Apply

Share this job

Similar Jobs

Project Manager - Early Phase

Parexel • Springfield, IL • 2h ago

Management & Administrative

Home Based (Preference for CA, CO, or TX locations) The Project Manager for Early Phase (EP) leads Parexel and Sponsor teams by leveraging clinical research experience and project management skills to develop tailored so...

2h ago

Go to Apply

Scientist III - Analytical Chemist (Drug Product) - FSP

Parexel • Springfield, IL • 8h ago

Hospital & Medical

We are looking to fill a Scientist III - Analytical Chemist (Drug Product) support position working as a full-time employee of Parexel FSP on long-term assignment onsite at one of our clients located in Rahway, NJ . This...

8h ago

Go to Apply

Clinical Laboratory Study Manager - FSP

Parexel • Springfield, IL • 9h ago

Hospital & Medical

Works with Precision Medicine Strategy Lead as well as clinical study teams, data management (DM) team, Samples, Kits, Data, Logistics (SKDL) and Clinical Laboratory Project Management (CLPM) groups to ensure quality sam...

9h ago

Go to Apply

Senior Principal Software Engineer

Oracle • Springfield, IL • 12h ago

IT & Engineering

Job Description Are you interested in building large-scale distributed infrastructure for the cloud? Oracle's Cloud Infrastructure team is building new File Storage Services that operate at high scale in a broadly distri...

12h ago

Go to Apply

Customer Service Representative

U-Haul • Springfield, IL • 18h ago

Management & Administrative

Compensation Range: $15.00 to $17.00 Hourly Location: 3650 S 6th Street Rd, Springfield, Illinois 62703 United States of America Are you a people person? Do you love helping others? U-Haul is in search of friendly, motiv...

18h ago

Go to Apply

Senior Enterprise Email Administrator

Illinois Department of Innovation & Technology • Springfield, IL • 18h ago

Management & Administrative

This job was posted by https://illinoisjoblink.illinois.gov : For more information, please see: https://illinoisjoblink.illinois.gov/jobs/13500878 Essential Functions Under administrative direction, serves as a Senior En...

18h ago

Go to Apply

Retail Manager-Part-Time Customer Experience Manager

Michaels • Springfield, IL • 20h ago

Retail & Hospitality

Store - SPRINGFIELD, IL Deliver a customer centric shopping experience by managing and delivering effective front-end operations and expectations. Lead the omnichannel processes. Maintain store recovery standards to deli...

20h ago

Go to Apply

CNA Nurse Aide

Springfield Illinois Homecare - Visiting Angels • Springfield, IL • 1d ago

Hospital & Medical

CNA Nurse Aide Description CNA Nurse Aide - $400 Bonus Available* Pay Rate: $16-$20/hour Differential pay for nights and weekends Weekly Pay! $400 Sign On Bonus Available* Flexible Hours Offering Full-time, Part-time, PR...

1d ago

Go to Apply

Vendor Risk Analyst

City National Bank • Springfield, IL • 1d ago

RISK ANALYST USMB WHAT IS THE OPPORTUNITY? This role will primarily be responsible for the execution of the first line of defense Risk Program, including the enhancement of internal controls and in performing internal co...

1d ago

Go to Apply

Sr. Business Analyst - Advertiser Operations, Capital One Shopping (Remote-Eligible)

Capital One • Springfield, IL • 1d ago

Management & Administrative

Sr. Business Analyst - Advertiser Operations, Capital One Shopping (Remote-Eligible) This is your opportunity to join Capital One's fast-growing consumer app: Capital One Shopping. Within Capital One, the Shopping team i...

1d ago

Go to Apply

Subscribe to get new jobs sent directly to you
(no charge, cancel anytime)