Manager of Quality Assurance

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Robert Half Technology
FDA, Manager, Management, Protocols, QA, Quality Assurance, Validation
C2H Independent, Contract Independent, Contract W2, C2H W2
$44.65 to $51.70 hourly
Work from home not available Travel not required

Job Description


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

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 subordinatesKey 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

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


Company Information

Robert Half Technology is committed to the industries we serve and to assisting them with their IT hiring needs. Our connections and strategic partners within the technology industry are second to none. We are proud members of the Microsoft Partner Network with gold and silver competencies, we have gold membership in the Oracle Partner Network, and we have exclusive relationships with The Wall Street Journal, HDI and the Association of IT Professionals. For job seekers, these connections can lead to top-rate opportunities within the IT recruitment arena. Our collaborative relationships around the world translate into support for all kinds of careers in IT, including IT support, software engineering, analytics and many other information technology areas of expertise.
Dice Id : rhalfint
Position Id : 00700-0011204348
Originally Posted : 1 month ago

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