QA Head Cover Letter

I would like to submit my application for the QA head opening. Please accept this letter and the attached resume.

In my previous role, I was responsible for oversight of CQA auditors and contract auditors to develop specific audit plans, review and assess internal and external audit reports to ensure they have met the audit plan and that recommendations and suggested Corrective Action Preventative Action Plans (CAPA) are adequate all to ensure compliance with Standard Operating Procedures (SOPs), Regulations, and Best Practices.

Please consider my experience and qualifications for this position:

• Set up processes and objectives to achieve consistency across all product lines
• Drive Test automation projects with the development teams (internal or external)
• Build business knowledge foundations to enable elasticity of UAT teams across the different lines of business
• Collaborate with other technology domains and the business to identify and improve testing
• Automation, continuous integration, continuous testing
• Strong UAT experience in agile and waterfall environments, small and medium sized projects
• Experience in supporting all quality assurance tasks in the development and software engineering process, conducting test strategy design and test script code reviews, test design and development activities in both a .net and Java environment
• Working with offshore and dispersed teams

In response to your job posting for QA head, I am including this letter and my resume for your review.

Previously, I was responsible for quality assurance expertise / guidance for GxP computerized systems classification, qualification, supplier assessment, change control, deviation management and associated activities that ensure compliance to regulatory and company expectations.

Please consider my qualifications and experience:

• Able to communicate status, needs, forecasts, risks and timelines effectively to management
• Displays a clear willingness to listen to others
• Shows commitment and dedication and strives to be ahead of schedule
• Working knowledge of appropriate global medical device regulations, requirements, and standards, such as 21 CFR Parts 803, 806, and 820, ISO13485, ISO14971, European Medical Device Directive (93/42/EEC), Canadian Medical Devices Regulation (SOR/98-282), Japanese MHLW Ordinance 169, and ISO 9001 (preferred)
• DMAIC, 8D, PRIDE and other problem solving, analytical skills and vast expertise in statistical techniques (preferred)
• Expert knowledge and demonstrated use of process and design excellence methodologies including DFSS
• Substantial industry experience in a site producing biological pharmaceutical products under EU and US standards including quality management experience
• A commercial outlook with attention to details

I am excited to be applying for the position of QA head. Please accept this letter and the attached resume as my interest in this position.

In the previous role, I was responsible for quality assurance expertise / guidance for GxP computerized systems qualification, supplier assessment, change control, deviation management and associates activities that ensure compliance to regulatory and company expectations.

Please consider my experience and qualifications for this position:

• Comfortable in a changing environment running multiple projects
• Experience in software release management processes and products/tools, DevOps methods
• Successful track record in setting up a (new) UAT framework
• Any experience on a production site will be an interesting added value
• Cultural awareness and sensitivity, cross cultural communication
• Demonstrated people management experience (direct/matrix)
• Demonstrated experience in successfully managing and lead cross-functional and interdisciplinary teams with high organizational impact
• Independently apply risk assessment and management techniques to objectively evaluate and deal with complex compliance issues with minimal supervision

In response to your job posting for QA head, I am including this letter and my resume for your review.

In my previous role, I was responsible for required support to both internal and external auditors and ensures 100% compliance to data provisioning requests.

Please consider my experience and qualifications for this position:

• ASQ certification as Certified Quality Engineer or DfSS/DMAIC Green Belt / Black Belt
• Expert knowledge of appropriate global medical device regulations, requirements, and standards, such as 21 CFR Parts 803, 806, and 820, ISO13485, ISO14971, European Medical Device Directive (93/42/EEC), Canadian Medical Devices Regulation (SOR/98-282), Japanese MHLW Ordinance 169, and ISO 9001
• Expert knowledge and demonstrated use of process and design excellence methodologies including Six Sigma
• DMAIC, 8D, PRIDE and other problem solving and analytical skills
• Detailed knowledge and understanding of aseptic technique, sterile drug product manufacturing and quality assurance operations
• Strong knowledge in the application of cGMP requirements, biomanufacturing processes, and purpose and function of supporting processes
• Understanding of the principles of biologics manufacturing
• Effectively presents information and ideas formally and informally, verbally and in writing to others in a manner that facilitates understanding

I submit this application to express my sincere interest in the QA head position.

In my previous role, I was responsible for gXP subject matter expertise as needed – perform critical assessments/data and document reviews, conduct audits, develop SOPs and role model investigation/problem solving skills.

Please consider my experience and qualifications for this position:

• A proactive approach which builds Quality & Compliance into processes
• A track record in building teams, and delivering outstanding effectiveness from those teams
• A good track record with the FDA, MHRA, EMEA and other regulatory agencies
• A good understanding of foundation principles of Lean & Six Sigma
• To provide independent QA oversight of all operations performed within the Process Unit
• To drive continuous improvements to enable best in class performance across Quality, Customer Service, Financial and EHS performance goals
• To provide leadership for all Quality associates and to ensure that they are fully trained, developed and motivated to achieve their full potential
• To be an effective and respected member of the Process Unit leadership team