Quality Issue Lead - FSP

Parexel • Hartford, CT • 6h 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

Materials Manager - Cold Section Supply Chain (Onsite)

RTX Corporation • Middletown, CT • 2h ago

Management & Administrative

Date Posted: 2026-05-30 Country: United States of America Location: US-CT-MIDDLETOWN-110 ~ Aircraft Rd ~ BLDG 110 Position Role Type: Onsite U.S. Citizen, U.S. Person, or Immigration Status Requirements: U.S. citizenship...

2h ago

Go to Apply

Registered Nurse (RN)

Trinity Health • West Hartford, CT • 5h ago

Hospital & Medical

Employment Type: Full time Shift: Day Shift Description: Saint Mary Home, West Hartford, CT Position: Registered Nurse (Charge) Saint Mary Home, located in West Hartford, Connecticut, proudly celebrated145 years of compa...

5h ago

Go to Apply

Certified Nurse Assistant (CNA)

Trinity Health • West Hartford, CT • 5h ago

Hospital & Medical

Employment Type: Part time Shift: Evening Shift Description: Join our Mission at Saint Mary Home Are you a Certified Nursing Assistant (CNA) with a heart full of compassion and a passion for making a difference? Then Sai...

5h ago

Go to Apply

barista - Store# 07836, ROCKY HILL TOWN CENTER WEST

Starbucks • Rocky Hill, CT • 6h 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...

6h ago

Go to Apply

Board Certified Behavior Analyst (BCBA) - Center - 8am to 4pm

Butterfly Effects • Agawam, MA • 6h ago

6h ago

Go to Apply

barista - Store# 65188, HAZARD AVE, ENFIELD

Starbucks • Enfield, CT • 6h ago

Retail & Hospitality

6h ago

Go to Apply

Registered Nurse (RN) Supervisor - Part Time

Trinity Health • West Hartford, CT • 6h ago

Hospital & Medical

Employment Type: Part time Shift: Night Shift Description: What to expect as a Nursing Supervisor at Saint Mary's Home Under the direction of the Director of Nursing Service, the Nursing Supervisor is responsible for the...

6h ago

Go to Apply

Project Manager - Early Phase

Parexel • Hartford, CT • 6h 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...

6h ago

Go to Apply

Sourcing & Procurement Management Marketing Consultant - NASPFY26

Accenture • Hartford, CT • 7h 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...

7h ago

Go to Apply

Scientist III - Analytical Chemist (Drug Product) - FSP

Parexel • Hartford, CT • 12h 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...

12h ago

Go to Apply

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