Supplier Quality Management Cover Letter

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

Previously, I was responsible for guidance to multifunctional teams to ensure that Quality processes are implemented to meet requirements for new product development and lifecycle management for drugs and medical devices under ICH, 21 CFR, EMA, ISO 13485 and 14971, MDSAP &MDR.

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:

• Understanding of automotive practices such as APQP/PPAP/VDA6.3/TS16949 is highly preferred
• Good interpersonal and communication skills (Business English, Presentations) to interact with external stakeholders, including suppliers and customers
• Able to work independently and travel frequently (e.g SE-Asia, China, Korea & Europe)
• Bachelor in Electronics/ Electrics, Physics
• Quality area experience if applicable
• Graduating senior or recent graduate with a B.A
• Preferably previous experience in the pharmaceutical or biopharmaceutical industry
• Preferably good knowledge of cGMP, GLP, good clinical practices, FDA Guidelines and Points to Consider documents, and standards routinely used in the industry (ANSI, ISO, Federal Standards)

I submit this application to express my sincere interest in the supplier quality management position.

In the previous role, I was responsible for expert advice, support and management for technical operational QA and general QA matters for specific vendors, on behalf of the company, in design/development of medical devices (including medical mobile apps) and combination products ensuring application of ISO and GMP requirements.

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

• Lead Changes proactively
• Enjoys leading and steering challenging topics in a problem solving oriented way
• Advaced English
• Ob Objective
• Functional and technical lead for defined material group of Plastics and Metal (ferrous & nonferrous)
• Define technical and commercial saving measures to reduce material costs
• Expert in Quality systems, VDA, IATF and ISO
• Able to evaluate suppliers on Cost, Quality, Delivery and Service parameters

I am excited to be applying for the position of supplier quality management. Please accept this letter and the attached resume as my interest in this position.

In the previous role, I was responsible for mentorship and direction to teams to ensure compliance to regulatory (e.g., cGMP, QSR, EU Directives, ISO standards, etc.) and company procedures is required.

Please consider my qualifications and experience:

• Preferably good knowledge of OE tools
• Strong interpersonal skills, which include a professional demeanor when interacting with personnel at all levels within Roche world wide operations, suppliers, contract manufacturers, regulatory agency representatives
• Minimum BA/BS in scientific discipline
• Driven individual with a history of developing collaborative, cross-functional solutions
• Prior experience in in-vitro diagnostics highly preferred
• Advanced Knowledge of Pharmaceutical regulations, standards (US FDA, 21 CFR Parts 210 and 211, cGMP, ICH, USP)
• Thorough Knowledge of API/Excipient manufacturing, Container-Closures, Packaging, Labeling and other supplied materials and their respective manufacturing processes
• Experience auditing CTLs, testing materials/raw materials, sterilization facilities

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

Previously, I was responsible for guidance and direction to teams to ensure compliance to regulatory (e.g., cGMP, QSR, EU Directives, ISO standards, etc.) and company procedures is required.

Please consider my qualifications and experience:

• Experience writing, evaluating and closing investigations, CAPAs and change control records
• Provide leadership and direction for lab-related and TMS issues - SCARs, CAPAs, OOS
• Lead, develop and manage staff
• Deep Knowledge in Quality policies, systems and processes
• Knowledge in the category of Passive Components will be highly appreciated
• Experience in leading several global teams and developing team members (Leading Leaders)
• Strategic, profit and quality oriented handling
• Act as a decision maker

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

Previously, I was responsible for advice, training and counsel concerning computer system regulatory requirements to staff on computerized system/validation projects and their business stakeholders in conformance with relevant cGxPs, guidance documents, applicable industry accepted standards and BMS requirements.

Please consider my experience and qualifications for this position:

• Make suppliers ready for future acquisitions and define the future technology road map for every supplier
• Analyze the commodity market with respect to business targets to Establish a standard and optimized supplier base to create synergies by bundling global volumes
• Create a clear development plan for every supplier and execute it within defined time frame
• Prepare and update the supplier matrix to ensure Program Purchasing targets of Cost, Time and Quality
• Generate ideas and support for commercial and technical optimization of components to reduce costs and improve quality and security of supplies
• Consolidation of supplier and materials to have a standardized base
• Involvement in the negotiation and conclusion of global supplier frame contracts (including pricing)
• Observe the global market situation, coordinate, carry out and keep track of the purchasing activities worldwide for the corresponding material group