Senior Manager, Quality Assurance Cover Letter

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

Previously, I was responsible for guidance to business unit on global compliance, such as CE Marking and product registrations, clinical evaluations in accordance with MDD Annex X, EU MDR (moving forward), ISO 13485 and ISO 14155, Canadian CMDCAS, US FDA’s and China CFDA’s guidance documents & etc.

Please consider my qualifications and experience:

• Experience in coaching, mentoring, motivating and supervising staff, particularly for globalized testing teams
• Experience in establishing and promoting QA processes and procedures
• A proven track record of delivering QA solutions through third parties such as ODMs and outsourcing partners
• Strong understanding of all QA processes and the importance of introducing quality at the beginning of the software life cycle
• Experience with testing of entire platforms, low-level, middleware, applications (mobile devices)
• Work experience leading QA across a multi-site, global environment
• A proven track record leading teams that have successfully delivered high complexity embedded products on time and with high quality
• Substantial experience with automated test suites

Please consider me for the senior manager, quality assurance opportunity. I am including my resume that lists my qualifications and experience.

In the previous role, I was responsible for guidance to clients and internal stakeholders on GMP matters and serve as a resource to internal stakeholders for the interpretation and application of regulations and applicable guidelines.

Please consider my qualifications and experience:

• Understanding of GMP/GDP regulations applicable for drug product manufacture, control, packaging and distribution
• Ideally, knowledge of other quality systems such as PV and ISO standards
• Proven auditing skills obtained in a regulated or pharmaceutical environment
• Able to interpret and implement quality system requirements according to current business and regulatory needs
• Able to interact with cross-functional teams effectively in order to deliver sound business results that meet high quality standards
• Broad knowledge of statistical quality control
• Knowledge of inspection and process control
• Knowledge of work performed in an office and factory settings

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

Previously, I was responsible for leadership and guidance on global compliance, such as CE Marking per MDR and product registrations, clinical evaluations in accordance with MDD/MDR, ISO 13485 and ISO 14155, Canadian CMDCAS, compliance with FDA’s guidance documents etc.;.

Please consider my qualifications and experience:

• Experience with testing and quality metrics, and metric-driven process improvement
• Familiarity with continuous integration tools and processes
• Practical experience and understanding of all GSE requirements relative to document
• Previous experience in managing (Including HR Management) of QA Automation teams in a DevOps Environment
• Experience with equipment, instrument, analytical method and process validation
• Excellent communication skills both oral and written, including negotiation and conflict management
• Experience in routine office software packages and specialized software applications as appropriate
• Specific expert knowledge in the area of HCC and quality assurance

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

In the previous role, I was responsible for guidance to BIUs on global compliance, such as CE Marking, EU MDR and product registrations, clinical evaluations in accordance with MDD Annex X, ISO 13485 and ISO 14155, Canadian CMDCAS, compliance with FDA’s guidance documents etc.

Please consider my qualifications and experience:

• Related experience in at least two different pharmaceutical manufacturing facilities is preferred
• Experience performing the duties related to Test Management and Quality Assurance
• Experience in application development, delivering multiple med-large scale projects/programs
• Experience with the development, deployment, and maintenance of Quality Management System technology solutions preferred
• Responds flexibly to shifting demands and changing priorities, proactively looking for ways to contribute
• Demonstrates attention to detail and high quality while meeting deadlines and commitments
• Collaborates with team members across functions and geographies to get work done while encouraging others to do the same
• Expert knowledge and understanding of the business unit’s key products and services, processes, controls and organization

Please consider me for the senior manager, quality assurance opportunity. I am including my resume that lists my qualifications and experience.

In my previous role, I was responsible for guidance to assure that all necessary Medical Education activities are in governmental and Medtronic quality compliance always, including, but not limited to ACCME, AdvaMed, ISO 9001, FDA regulations, and QSR(GMP) standards.

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:

• Experience in audit, internal control, risk management and compliance are advantage
• In-depth knowledge of GMP and ICH requirements and applications for biologic drug substance and drug product manufacturing
• Comfortable in a fast-paced company environment that requires adjusting workloads based upon changing priorities and willingness to do whatever needs to be done, regardless of level or type of work
• Pharmacist Qualification or related education
• Extensive knowledge of GxP change control, investigations, validation and training requirements
• Extensive knowledge of warehouse and manufacturing processes and operations
• Have worked as a part of an Agile Scrum team
• Solid understanding of manufacturing process – footwear in particular