Director, QA Cover Letter

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

In the previous role, I was responsible for expert opinion, advice and recommendation to the Vice President Quality assurance and Regulatory Affairs - Americas regarding Quality Assurance.

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:

• Knowledge and demonstrated experience with GxP audit processes
• Experience with resource projections and tracking utilization
• Understanding of audit planning
• Practical knowledge of current and emerging relevant regulations
• Mastery of written and spoken English
• Willing to travel globally, including outside normal working hours
• Strong grasp of web and software development lifecycle concepts
• Experience with agile methodology in addition to traditional waterfall development

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

In the previous role, I was responsible for advice and guidance on maintaining the validated state and ensuring compliance to FDA guidelines and regulatory requirements.

Please consider my qualifications and experience:

• Knowledgeable on security (such as NG firewall) technologies
• Knowledge in using security testing tools & traffic generators
• Possess strong Leadership skills and mentoring of groups of engineers and managers
• Experience of having worked as a member of a SCRUM team delivering high quality software in two week sprints
• Develop and propose remediation plans for global and / or cross-divisional implementation, where identified as a potential systemic gap, for the GMP committee
• Experience with test automation and SQL
• Experience working in Contract Manufacturing (CMO)
• FDA auditing experience mandatory

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

In my previous role, I was responsible for quality oversight of Sterility Assurance and ensure that all Sterility Assurance aspects of site manufacturing processes and products manufactured by the site are compliant with GSK standards and regulatory requirements.

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

• Expertise in GMP strong knowledge of GLP and GCP
• Demonstrated knowledge of complaint handling systems (Trackwise or similar) and their advantages and limitations
• Experience managing complaint handling teams in a fast-paced environment
• Broad and in-depth knowledge of the drug development process, GCP/PV guidelines, and applicable regulations is essential
• Familiarity with existing company systems, policies and procedures and knowledge of multiple therapeutic areas and nonclinical study conduct, including all projects/premier products is desirable
• Probes all sources for answers
• Goes beyond the obvious and seeks novel approaches to complex situations
• Able to communicate complex information and analyses to a variety of scientific and non- scientific audiences in both verbal and written formats

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

In my previous role, I was responsible for guidance on EU MDR as well as 21 CFR 820 & 21 CFR Part 11.

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

• B/S in Engineering, Industrial Management
• Knowledge of company's products
• Knowledge of management
• Read and write English documents
• Extensive experience in Quality and/or Regulatory management
• Previous background and experience in medical device quality
• Strong knowledge and experience in global quality requirements, with an emphasis on and the MDD
• Successful interactions with global Quality and Regulatory teams

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

In the previous role, I was responsible for support in the preparation and submission of quality/regulatory applications with the FDA and other regulatory authorities, including the review and compilation of CMC and other quality documents.

Please consider my experience and qualifications for this position:

• Managing project schedules and task details and utilize project management tools such as reports, tracking charts, checklists, and project scheduling software to delegate work responsibility
• Facilitate steering and project governance meetings with the client IT leadership
• Facilitate business prioritization meetings with the business leadership
• Engage technical team members to collaborate on time-sensitive issues and articulate issues back to the client
• Analyze risk and instigate avoidance activities
• Organisational Change
• Technology Change
• Specific expertise in Programme/Portfolio management and delivery of large and complex programmes