Project Manager, Quality Cover Letter

In response to your job posting for project manager, quality, I am including this letter and my resume for your review.

In my previous role, I was responsible for assurance that GxP regulated Computerized Systems are implemented, released and managed in accordance with internal and regulatory requirements.

My experience is an excellent fit for the list of requirements in this job:

• Conducts internal and external quality audits and issues report to promote continuous process improvement
• Performs on-site quality control surveillance, inspections, and enforcement in accordance with the project Quality Control Plan
• Serve as the Quality Control Manager in accordance with the Project Quality Control Plan
• Prepares project Quality Control documents and reports in accordance with establish plans
• Maintains Quality Control data using approved Quality Control data management systems
• Ensures contractor adherence to all quality control and contract requirements
• Conduct periodic follow-up inspections to verify that work is proceeding with the contract documents and the approved submittals
• Clearly document, correct and re-inspect all non-conformances prior to completing the work

I would like to submit my application for the project manager, quality opening. Please accept this letter and the attached resume.

Previously, I was responsible for proactive analysis and options for systems and operations changes to implement regulatory requirements from CMS (Center for Medicaid Services) regarding the system.

My experience is an excellent fit for the list of requirements in this job:

• Protus and PRIME competence
• Manages change control against cost and impact to schedule, scope, and quality
• Experience delivering global or multi-regional projects preferred
• Develop and Maintain a Central Non-Conformity Database and process
• Manage corrective and preventive actions related to non-conformities and coordinate activities of Project Continuous Improvement that will prevent their reoccurrences
• Manage and assign corrective action and follow-up on audits of the Consortium and major suppliers
• Execute the Project NCC (Non-Conformance Cost) reduction program
• Issue Monthly (and Annual) Reports including their different Key Performance Indicators regarding the Quality activities across the project

In response to your job posting for project manager, quality, I am including this letter and my resume for your review.

Previously, I was responsible for support to maintain quality system in compliance with current regulatory requirements and standard on multiple sites, and global policies.

I reviewed the requirements of the job opening and I believe my candidacy is an excellent fit for this position. Some of the key requirements that I have extensive experience with include:

• Pro-active personality with a strong quality mind-set
• Sound knowledge of regulatory guidelines (ICH, ISO, FDA, EU )
• Strong communication skill in English (C1)
• Project orientated approach and understanding
• Systematic and analytical thinking
• Fluent oral and written skills in English and Finnish
• Working knowledge of EFT debit processing and associated settlement processes
• Demonstrate an understanding of EFT transaction flows, on-line and off-line production support, settlement and reporting support

In response to your job posting for project manager, quality, I am including this letter and my resume for your review.

In my previous role, I was responsible for timely and regular updates to management on changes in regulations related to quality/ post-market requirements in ASEAN.

My experience is an excellent fit for the list of requirements in this job:

• Knowledge of Quality methods and tools (8D, Six Sigma)
• Fluent English and Swedish are mandatory
• PE/AIA license, ASQ Certification, and in experience in a multi-disciplinary design environment preferred
• Engineering Background with 3 yrs or more of experience (transport industry & railway industry preferred)
• Expertise in databases and CAD drawings - Project management experience in the above-listed project types, including proposal development, technical supervision and project administration - Experience in other industries including oil and gas, pipeline
• Quality Background with 3 yrs or more of experience (transport industry & railway industry preferred)
• Significant experience as a PMO Analyst, PMO Consultant, Project Delivery Manager, or related role
• Excellent written and verbal communication skills & collaborative work style, dealing effectively with senior stakeholders

I would like to submit my application for the project manager, quality opening. Please accept this letter and the attached resume.

In my previous role, I was responsible for oversight and QA approvals for GxP Deviations, CAPAs and change controls to ensure activities are conducted in compliance with Gilead procedures and regulatory requirements.

Please consider my experience and qualifications for this position:

• Agile Tools (TFS, JIRA, etc)
• Testing automation tools (UFT, QTPro, ..) would be highly valuated
• Analyze and custom SQL, .NET and J2EE solutions
• Support, train, mentor and provide guidance to validation team members specialists/engineers non-technical colleagues in the delivery of Computer System Validation (CSV) services for assigned projects
• Stay current (training, reading, professional organization involvement) with industry trends and current CSV methodologies
• Proficient with SAP and Microsoft Office applications (Word, Excel, Project, PowerPoint)
• Knowledge of air quality regulations in the Southeastern US
• Proficient in the use of computers to perform engineering calculations, spreadsheets, and report writing