Director, Assurance Cover Letter

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

Previously, I was responsible for financial leadership in the development or improvement of Global R&D Project Management & Portfolio systems, business practices, and processes, ensuring continuity of how those activities are reported and measured on a global basis and alignment to all financial reporting and planning systems.

Please consider my qualifications and experience:

• Has solid to expert experience in programming languages, software engineering methodologies, software development tools
• Experience dealing with regulatory compliance programs in particular Records Management, or risk management programs
• A high level understanding of process frameworks and controls - for example, Process Control Frameworks and Records Management standards
• Extensive experience in various SDLC (Software Development Life Cycle) methodologies such as waterfall, agile
• Superior capabilities for partnering with key customers and colleagues
• Working knowledge of strategic analysis frameworks such as SWOT, value chain, growth-share matrix
• Tertiary qualification in computer science, IT or related or extensive experience in a relevant role
• Familiarity with advanced quality processes preferred, - PPAP/ APQP/PFMEA/8D or A3 problem solving

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

In the previous role, I was responsible for oversight to the external audit process and the compilation of the college's financial statements and tax returns.

Please consider my qualifications and experience:

• Coordinates and plans all inspection, testing and surveillance activities
• In-depth knowledge of tools, concepts and methodologies of QA
• Minimum of Bachelor of Science in Food Science or Biology or a related field with a background in Microbiology, Chemistry and Mathematics
• Certification and/or License -- GFSI (SQF Practitioner)
• Masters in Business or Field of study preferred
• Background in sterilization or healthcare disposables preferred
• Lean Six Sigma understanding & experience
• ISO understanding & experience

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

In my previous role, I was responsible for financial management, financial analysis, and business perspectives that expand beyond just financial reporting and expense management.

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:

• Thorough understanding of software engineering methodologies and processes
• Knowledge of the latest Automation Testing Tools and Frameworks
• Operational Team Supervision
• Experience in leading an ISRM customer assurance team
• Certification in Quality Assurance, such as CQA, or Regulatory Affairs (RCA)
• Experience with GxP compliance management systems
• Uses expertise or unique knowledge and skills to contribute to the development of company objectives and principles, and to achieve goals in creative and effective ways
• Experience in Lean/Six Sigma or other proven improvement methodologies

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

In the previous role, I was responsible for independent Quality Assurance to GSK R&D, by delivering the audit program including defining scope, conducting audit processes, reporting observations and ensuring receipt and review of CAPA plans.

Please consider my experience and qualifications for this position:

• Approve or reject, starting materials, packaging materials, and intermediate, finished products, and to evaluate batch production records
• Ensure that all necessary QC testing is performed on manufactured products
• Approve specifications, sampling instructions, test methods and other Quality Control procedures
• Review and Approve site Annual Product Reviews
• Require approval and monitoring of suppliers of materials
• Ensure the proper designation and monitoring of storage conditions for materials and products
• Serve as site's primary contact with both customers and regulatory agencies regarding quality/compliance issues
• Analyze, resolve, or assist in solving compliance and customer issues

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

In my previous role, I was responsible for leadership, education and support to physicians and staff to develop their understanding of current supply chain management practices/products which support operational and financial goals.

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

• Technical proficiency in information technologies
• Knowledgeable of FEP business functions/disciplines
• Excellent skills in producing capacity planning and project requests that contain alternatives, justifications, or analysis that go beyond just delivering data
• Experience regularly presenting to Senior Management and Business owners
• Strong project management skills with strong research and analytical skills
• Extensive knowledge of FDA regulations relevant to drugs, devices, biologics
• Thorough knowledge and understanding of medical, laboratory, and clinical trial concepts and terminology
• Engaged team member motivated to work consistently in a fast-paced, “customer-focused” environment