Quality Issue Lead - FSP

Parexel • Oklahoma City, OK • 1h 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

Patient Care Technician - PCT

Fresenius Medical Care • Warr Acres, OK • 1h ago

Hospital & Medical

PURPOSE AND SCOPE: Functions as part of the dialysis health care team in providing safe and effective dialysis therapy for patients under the direct supervision of a licensed nurse in accordance with organization policie...

1h ago

Go to Apply

Welder

NOV • Oklahoma City, OK • 1h ago

Manufacturing & Warehouse

PRIMARY RESPONSIBILITIES Lay out, position, align and fit components together using applicable machines, tools and equipment. Bolt, clamp and tack-weld parts to secure them in position for final welding. Set up and weld...

1h ago

Go to Apply

Sr Staff Systems Administration Engineer - Kittyhawk ERP DBA Lead

GE Aerospace • Oklahoma City, OK • 1h 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...

1h ago

Go to Apply

Sourcing & Procurement Management Marketing Consultant - NASPFY26

Accenture • Oklahoma City, OK • 1h ago

Management & Administrative

We are: Sourcing & Procurement, and we move fast, think fast, and work fast. Our clients need big-picture change, so we come at their challenges from all sides with functional insights, data power, digital leadership...

1h ago

Go to Apply

Scientist III - Analytical Chemist (Drug Product) - FSP

Parexel • Oklahoma City, OK • 7h 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...

7h ago

Go to Apply

Google (AGBG) Mid Market Sales Account Executive

Accenture • Oklahoma City, OK • 7h ago

Sales & Marketing

WHO WE ARE: A leading partner to the world's major cloud providers, including AWS, Azure, and Google. The formation of Accenture Cloud First, with a $3 billion investment over three years, demonstrates our commitment to...

7h ago

Go to Apply

Azure Scrum Master - 6314202

Accenture • Oklahoma City, OK • 7h ago

?Accenture Flex offers you the flexibility of local fixed-duration project-based work powered by Accenture, a leading global professional services company. Accenture is consistently recognized on FORTUNE's 100 Best Compa...

7h ago

Go to Apply

Banking Product Owner Senior Manager

Accenture • Oklahoma City, OK • 7h ago

Finance, Accounting & Banking

Accenture is a leading solutions and services company that helps the world's leading enterprises reinvent by building their digital core and unleashing the power of AI to create value at speed across the enterprise, brin...

7h ago

Go to Apply

Fleet Mechanic

US Foods • Oklahoma City, OK • 7h ago

Manufacturing & Warehouse

ARE YOU A CURRENT US FOODS EMPLOYEE? PLEASE APPLY DIRECTLY THROUGH OUR INTERNAL WORKDAY CAREER SITE ( https://www.myworkday.com/usfoods/d/task/2998$47185.htmld ) Join Our Community of Food People! BASIC PURPOSE To provid...

7h ago

Go to Apply

Banking Payments Senior Manager

Accenture • Oklahoma City, OK • 7h ago

Finance, Accounting & Banking

7h ago

Go to Apply

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