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Associate Qa Automation Jobs in Delaware (NOW HIRING)

Apex Informatics

Automation Tester ACSEEYK3

Newark, DE · On-site

$45 - $59.50/hr

Automation tester with selenium, Java, SQL, ETL/Database testing The Fraud and Claims Quality Assurance team is looking for a Senior Automation Tester in Java. • Candidate will be required to ...

Hologic Inc.

CAPA Facilitator Associate

Newark, DE · On-site

$78K - $122K/yr

As a CAPA Facilitator Associate , you will support a broa d range of quality system and quality assurance activities. You will use data, quality tools, and cross-functional collaboration to assess ...

Hologic

CAPA Facilitator Associate

Newark, DE · On-site

$78K - $122K/yr

As a CAPA Facilitator Associate , you will support a broa d range of quality system and quality assurance activities. You will use data, quality tools, and cross-functional collaboration to assess ...

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Associate Director, Clinical R&D QA US

Wilmington, DE • On-site

Biopharma Careers
See more jobs at Biopharma Careersexternal

$35.50 - $47.25/hr

Other

Posted 11 days ago

Job description

Overview

A global biopharmaceutical company on a mission to Solve On, Incyte follows science to find solutions for patients with unmet medical needs. Through the discovery, development, and commercialization of proprietary therapeutics, Incyte has established a portfolio of first-in-class medicines for patients and a strong pipeline of products in Hematology, Oncology and Inflammation and Autoimmunity Headquartered in Wilmington, Delaware, Incyte has operations in North America, Europe, and Asia.

SUMMARY

This position is responsible for providing GCP oversight of Clinical development teams to the Head of Incyte Global R&D QA. This role will also include the execution and management of Incyte QA GCP audits and the provision of GCP guidance and advice across assigned Clinical Development programs. The Senior Manager Clinical R&D QA is also the QA lead for clinical inspection activities related to the clinical programs under its quality oversight.

DUTIES AND RESPONSIBILITIES
  • Provide QA GCP advice and support to Incyte Clinical Development/Operations functions and other relevant functions as assigned.
  • Plan, schedule and conduct audits of Clinical Investigator Sites, Vendors, , Trial Master Files and Clinical submission documents.
  • Assist with the management of QA consultants performing audits on behalf of Incyte QA.
  • Lead regulatory authority inspections activities for development programs assigned including conducting pre-inspection audits, inspection readiness activities and coordination/hosting inspection role, as assigned.
  • Coordinate responses and corrective/preventative actions from deviations, audit and regulatory findings.
  • Assist with the maintenance of the clinical Quality Management System including QA support for change control, deviations, review/revision of SOPs with ensuring continuous process improvement.
  • Stay abreast of clinical trial requirements, ICH GCP, and guidelines from other regulatory agencies for the management of clinical trials as appropriate.
  • Alert Global Clinical R&D QA Upper Management of internal and external GCP compliance and clinical trial issues in a timely manner.
  • Mentoring Junior Clinical QA as assigned.
  • Promote Quality Culture with external R&D stakeholders, as assigned.
  • Stay abreast of local/country clinical activities/initiatives from Regional Clinical Operations members and ensure necessary QA oversight in place as Clinical R&D QA Point of contact.
  • Conduct GCP training for Incyte staff.
  • Be knowledgeable and be able to understand advanced operational, scientific and/or clinical research areas.
  • Be thoroughly familiar with assigned Incyte Compounds and protocol.
REQUIREMENTS
  • Bachelor’s degree in a science or healthcare related discipline, or similarly conferred degree from a university.
  • 5 to 7 years’ experience in a pharmaceutical or bio-pharmaceutical company in a GCP QA role or Clinical compliance role.
  • Minimum of 5 years’ experience performing GCP audits of investigator sites and/or CROs.
  • English fluency written and spoken (the company language).
  • Regulatory inspection experience as coordinator or key role.
  • Ability to travel up to 30%.
  • Excellent written and oral communication skills.
  • This role is office-based.

Incyte Corporation is committed to creating a diverse environment and is proud to be an equal opportunity employer.

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