Quality Issue Lead - FSP

Parexel • Atlanta, GA • 3h 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

Inventory Control Coordinator - Loews Atlanta

Encore • Atlanta, GA • 31min ago

Management & Administrative

Position Overview Monitors and ensures accurate and timely data entry and transaction completion in Helios IC. Investigates and determines inventory discrepancies using Helios IC tools. Responsible for entering transacti...

31min ago

Go to Apply

barista - Store# 08413, COLEMAN VILLAGE

Starbucks • Roswell, GA • 3h ago

Retail & Hospitality

Crafting the world's finest coffee, one meaningful moment at a time We believe in creating a warm and welcoming space where every cup of coffee sparks connection. Every shift is a chance to brighten someone's day. Whethe...

3h ago

Go to Apply

barista - Store# 49207, Peachtree Station PIB & Johnson Ferry

Starbucks • Atlanta, GA • 3h ago

Retail & Hospitality

3h ago

Go to Apply

Store Manager

Walgreens • Decatur, GA • 3h ago

Retail & Hospitality

Job Description: Job Objectives Manages the operation of a Walgreen store. Improves store sales, profitability and image through proper merchandising, protection of store assets, the selection, training and development o...

3h ago

Go to Apply

Shipping Account Planner

PVH Corp. • Palmetto, GA • 3h ago

Manufacturing & Warehouse

About Us: We are brand builders who focus our passion and creativity to build Calvin Klein and TOMMY HILFIGER into the most desirable lifestyle brands in the world and at the same time position PVH as one of the best-per...

3h ago

Go to Apply

Sr Staff Systems Administration Engineer - Kittyhawk ERP DBA Lead

GE Aerospace • Atlanta, GA • 3h ago

IT & Engineering

Job Description Summary Combined role with responsibility for assigned ERP Kittyhawk and bolt-on applications' databases and platforms and responsibility for ERP Kittyhawk related application support leadership. The role...

3h ago

Go to Apply

Phlebotomist Specialist-Client Office

Labcorp • Atlanta, GA • 3h ago

Hospital & Medical

Labcorp is a global leader in diagnostic testing and drug development solutions, helping healthcare providers, researchers, and patients make informed decisions that advance care. Join us in our mission to improve health...

3h ago

Go to Apply

Project Manager - Early Phase

Parexel • Atlanta, GA • 3h 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...

3h ago

Go to Apply

Workers' Compensation Paralegal

Robert Half • Atlanta, GA • 3h ago

Legal & Paralegal

Description ?? Workers' Compensation Paralegal | Atlanta, GA ?? Are you a compassionate and detail-oriented Workers' Compensation Paralegal looking to join a close-knit, client-focused law firm? Our client, a well-establ...

3h ago

Go to Apply

Senior Director of Facility Operations - Campus Services

Emory Healthcare/Emory University • Atlanta, GA • 3h ago

Management & Administrative

Discover Your Career at Emory University Emory University is a leading research university that fosters excellence and attracts world-class talent to innovate today and prepare leaders for the future. We welcome candidat...

3h ago

Go to Apply

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