Job description

Requirements

  • Entry level
  • No Education
  • Salary to negotiate
  • New Haven

Description

This is a permanent full time role located on site in New Haven, CT.
Candistes must be eligible for permanent full time eemployment without sponsorship.
Company is NOT able to sponsor candidates.

8 or more years' Quality / Regulatory Assurance experience in Clinical Trials/Pharmaceutical areas (experience in Medical Devices area will be an added advantage)

Experience with Software validation in a Healthcare environment is mandatory for this role.

The position plays a major role within the QA department and the company as a whole in ensuring compliance to GCP, FDA and other applicable regulatory requirements.
QA Manager is the appointed Quality Management Representative for the US offices and is responsible for establishing and maintaining a Quality Management System that will ensure compliancy with appropriate regulatory guidelines including ICH Good Clinical Practice E6, Electronic records handling as defined by FDA regulation 21 CFR Part 11, Medical Devices Regulations and other applicable regulations.

Requirements:

Minimum of a Degree in a science or engineering discipline and a minimum:


8 or more years' Quality / Regulatory Assurance experience in Clinical Trials/Pharmaceutical areas (experience in Medical Devices area will be an added advantage)


- Qualified or trained internal auditor
- Experienced in coordinating Customer/Vendor audits and management of resultant findings and CAPA
- Excellent understanding of Software Validation principles
- Good understanding of 21CFR Part 11, Medical devices regulations and ICH-GCP requirements.
- Proven track record in delivering quality results in a timely effective manner in a team-based environment
- Excellent understanding and experience of Good Clinical Practice (GCP) principles and implementation

Essential Job Functions:

Key responsibilities:


- Lead regulatory inspections (e.g.
FDA) and customer audits.
This includes pre-audit/inspection preparations, portraying professional approach during the inspection/audit conduct and providing responses to and closure of resultant findings/process gaps in a timely manner.
- Manage Healthcare QMS and all Regulatory Activities such as Customer complaints, Recall, and Post-market vigilance reporting
- Ensure software validation protocols and associated validation runs are in compliance with FDA guidance and Software Validation Principles, FDA 21 CFR Part 11 requirements and various regulatory requirements.
- Manage internal audits per established schedule.

Other duties:


- Assist in establishing and maintaining the effectiveness of the quality management system as a whole
- Assist in creation and ongoing review of QMS documentation, highlighting any gaps encountered with reference to GCP E6, 21 CFR Part 11 and other applicable regulatory requirements.
- Manage all Vendor Management activities such as Vendor Evaluation/re-evaluations, Vendor audits, Vendor file management and updates.
Manage Document and Change Control, Deviation, Non-conformances and CAPAs as needed.
- Manage the overall quality and provide guidance and constraints to the teams.
- Approve quality documents (including validation protocols and reports) and authorize releases and deviations on behalf of the Sr.
RA/QA Manager.
- Work with and provide necessary guidance to all the departments in creating, revising, implementing, and obsoleting procedures and specifications.
Approve software/product releases for customer use.
- Manage Healthcare QMS and all Regulatory Activities such as Customer complaints, Recall, and Post-market vigilance reporting.

Mentor and develop subordinates.

Experience in FDA inspection handling, post-market activities (change management, complaints, CAPA and recalls)

  • software