Director, Quality Assurance Cover Letter

I submit this application to express my sincere interest in the director, quality assurance position.

In the previous role, I was responsible for support for all aseptic related operations assuring that processes in place are compliant with applicable regulations, Pfizer standards and aligned with network practices and regulatory expectations.

Please consider my experience and qualifications for this position:

• Thorough knowledge of FDA Quality System requirements, ISO 13485 (Quality System) requirements, ISO 14971 (Risk Management) requirements, Medical Device Directives (MDD) requirements, Knowledge of Good Manufacturing Practices (GMP) and applicable Quality System Standards
• Knowledge in managing projects, analytics and presenting towards management
• Able to coach/train and demonstrate success in planned actions for improvement
• Strong product manufacturing technical background knowledge of Medical Device Quality System regulations
• Experience in product manufacturing transfers, facility/line startup
• Typically referred to as technical expert and known internally and externally as reliable, knowledgeable resource
• Knowledge of quality or customer experience principles
• Experience working with internationally based designers, engineers, landscape architects, quantity surveyors and suppliers

I submit this application to express my sincere interest in the director, quality assurance position.

In the previous role, I was responsible for input on decisions regarding concepts and draft promotional materials to satisfy the letter and spirit of FDA promotional regulations, corporate standards and policies and business objectives.

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:

• Prepares a yearly assessment regarding the status and adequacy of the Specialty Welding Quality Assurance Programs
• Serves as an interface with client representatives on quality related issues
• Plans, performs and documents quality training indoctrination sessions
• Plans appropriate hardware inspection and testing methods
• Provides work direction to quality personnel as needed
• Advises project management personnel on quality related matters and keeps them informed of the quality assurance implementation status both within Specialty Welding and site locations
• Assists project personnel with development and maintenance of accurate project planning documentations
• Maintains a working awareness of events occurring within the nuclear industry and provides input to management when events have potential impact on hardware and technologies

I submit this application to express my sincere interest in the director, quality assurance position.

In my previous role, I was responsible for technical expertise and assistance in handling complaints to comply with current FDA reporting regulations.

Please consider my qualifications and experience:

• Excellent interpersonal and writing and oral communications skills
• BS in Engineering / Technical / Science
• Manage and oversee all local vendor GxP audits and assessments, including but not limited to PV, REMS, GMP audits at Specialty Pharmacies, inpatient pharmacies, REMS related data/IT vendor audits
• Experience in troubleshooting issues, running Charles sessions (or similar tools), evaluating network calls, events and triggers
• Expert knowledge of Testing tools, testing methodologies, test case management and estimation strategies
• Clear understanding and good handle on JSON, XML, HTML, CSS and other technologies
• Successful leader with experience in building and leading a shared service discipline in a large matrixed enterprise, preferably with global/virtual team experience
• Proven track record of translating organizational strategy into actionable solutions that drive operational excellence while enabling synergistic growth and organizational scale

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

In the previous role, I was responsible for leadership for and manage regulatory aspects of the copy review / approval process for promotional materials, ensure compliance of promotional materials with FDA laws, regulations and published guidance documents.

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

• Lead the quality assurance and quality control teams in a group of global sites to deliver high performance to meet key targets
• Strong knowledge of quality systems and be innovative with them as the industry changes
• Thorough knowledge of legal procedures with food safety and environmental policies
• Develop and implement Site Quality Plan, Quality Unit objectives and related procedures
• Interface with all other departments to ensure compliance with cGLP/cGMP
• Monitor site compliance to FDA, EU and all other applicable requirements
• Establish a process to review and Implements site procedures in alignment with the Corporate policies
• Direct a team of Quality professionals

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

In my previous role, I was responsible for broad-based technical guidance in the oversite of validation and production protocol design and execution, ensuring compliance with FDA and global regulations as well as Emergent internal directives.

Please consider my experience and qualifications for this position:

• Quality Management System Development and Implementation
• Preferred ASQ certification or specialized training related to QA systems and practices
• Knowledge of QA systems and best practices, including QA requirements for regulated studies conducted for FDA, EPA, NIH, and other federal agencies
• Knowledge of and experience with current technologies
• Experience with the Microsoft Office suite of applications (i.e., MS Word, Outlook, PowerPoint, Excel, Visio)
• Foster a diverse workplace that enables all participants to coontribute to their full potential in pursuit of organizational objectives
• Experience managing quality engineering functions within both a device and drug/device manufacturing environment strongly preferred
• BA/BS in a Science related major