Quality Senior Manager Cover Letter

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

In my previous role, I was responsible for leadership for Quality Operations Solid Dose Manufacturing facilities as part of the Pharmaceutical Sciences Quality Assurance organization, including implementation of effective quality systems, maintaining high quality and compliance performance, implementing risk and science-based product quality development approaches, and timely disposition of investigational material products.

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:

• Strong on MI reporting
• Black Belt / OPEX / Statistical analysis (SPC) and problem solving tools (Drill Deep Drill Wide, 5Why, 7D, 1X1)
• Conversant with software applications for Microsoft Windows including Excel, PowerPoint and Word
• A self-starter able to function independently with minimum direction and to act on behalf of the Director of Quality Assurance in his/her absence
• Assesses and coaches to strengths and developmental needs of project team members and direct reports
• Fosters and encourages frequent, open and honest feedback
• Solid background in quality engineering
• Six Sigma Black Belt qualification desirable

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

In the previous role, I was responsible for regular reports to Business Unit Operations and Quality management (including KPIs) and represent the Customer Quality view within the organisation).

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:

• Good understanding of SOX, audit and other financial reporting requirements
• Claim adjudication experience or audit experience
• Experience with design and development of risk and/or quality programs
• Expertise in pharmaceutical product quality
• Wide knowledge in MN portfolio and process, especially in NI
• To be a team player working in a strong virtual networking environment
• Self-Motivated, Handle Multiple Tasks
• Self-Motivator and able to lead small teams in complex objectives

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

In my previous role, I was responsible for project management support to the Quality Systems & Compliance unit with the primary function being to assist the Quality Risk Management (QRM) manager.

Please consider my qualifications and experience:

• Intermediate to advanced skill level of MS Word, Excel, Access, AutoCad or equivalent
• Expertise with the domestic and international medical device regulatory environment including the CE Mark, 510(k)/PMA process and approvals, FDA audits and review, design control documentation and internal guidelines
• Broad extensive knowledge of methods, processes, equipment, and techniques in manufacturing, development and engineering
• Multi-site and multi-regional research and development leadership exposure and success
• Job related technical quality knowledge necessary to complete the job
• Thorough working knowledge of local regulatory requirements in the pharmaceutical industry, especially GDP and the local requirements for wholesale distributors
• Thorough working knowledge of the relevant sections of the EU regulation, EU directives and ICH guidelines
• Pharmaceutical technical knowledge

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

In the previous role, I was responsible for quality guidance and support for manufacturing and quality projects and programs, ensuring compliance with relevant GxP regulations and internal policies.

Please consider my experience and qualifications for this position:

• Experience with Quality testing preferred
• Experience leading analysis of data trends and root cause, especially in a Quality Management environment
• Knowledge of operational systems (e.g., VCARS, SNAP, Web Collections, Docuware, SalesForce CMS, NICE Interactions Manager)
• Demonstrated knowledge of Quality Management or related field
• Strong PC skills in a Windows-based and technology-driven environment
• Lean six sigma Green Belt certification (Preferably)
• Competent in Project planning, Project Leadership and team facilitation
• Facilitate Leadership skills - influencing skills, mentoring and coaching – to be able to

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

Previously, I was responsible for experience on microbial control strategies for pharmaceutical manufacturing and product, process and microbial risk assessments execution; general knowledge of quality risk management (QRM).

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:

• Intense training and experience in quality methods
• Experience in terms of supplier evaluation
• Founded and business fluent knowledge in English language, additional knowledge in Chinese or German language is a benefit
• Sound network in the relevant quality community
• Able to manage budget for assigned department
• Able to read and interpret production drawings
• Able to train and lead others
• Quality functional expertise – including set up and maintain strategic supplier base, supplier management, communication of company quality objectives and supervise of suppliers implementation