Senior Manager, Quality Cover Letter

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

Previously, I was responsible for fDA / ISO audit support and ensures R&D laboratories are compliant with all applicable policies and regulations.

Please consider my experience and qualifications for this position:

• Fluent (both oral and written) in English, completely comfortable communicating on a detailed, professional level
• Ethical - in concert with J&J credo, policies & ETHICON ENDO-SURGERY corporate policies
• Six Sigma Black Belt(Preferred), Green Belt considered
• Development and Implementation of Quality management software solutions
• Extensive experience in operations, quality or research and development (preferably in device/drug or biomedical area), incl
• Knowledge of finance and accounting business functions
• Knowledge of high volume, state of the art manufacturing processes, preferably in the medical device industry
• In-depth knowledge of state, federal and corporate policies/standards (GMP, ISO 9000, SOPs)

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

Previously, I was responsible for leadership and a clear understanding of quality standards that meet the requirement of ISO 17025, the Element location Level I Manual and safety compliance regulations and local policies.

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

• Experience with public and private sector clients including developers and institutional clients
• Experience with design build project delivery and integrated project delivery methods
• Organizational skills to insure quality and timely delivery of projects
• Working knowledge of regulatory compliance and Experience working in a GMP environment
• Consistently deliver on commitments and respond to customers’ needs in a timely and courteous manner
• Experience of working within a manufacturing environment, within a highly regulated industry
• Demonstrable involvement during implementation of a quality management system
• Previous responsibility for people management

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

In the previous role, I was responsible for support and maintain compliance with all company guidelines, IATF 16949, ISO14001, and all applicable government regulations and standards.

Please consider my qualifications and experience:

• Staying informed on emerging safety and regulatory issues and using technical expertise to assess risk and propose solutions to management
• Leading training and coaching internally and externally on raw material quality and food safety best practices
• Participating with external organizations in assigned raw material categories to gain information and positively influence change relevant to our business needs
• Thorough knowledge of functionality and processing effects on raw materials in multiple food or process categories
• Demonstrates strong problem solving (Advanced problem solving tools experience) and project management skills including root cause analysis, risk assessment and corrective/preventive action
• Demonstrated experience to function effectively as a project manager, planner, coordinator, and communicator
• Experience with World Class Manufacturing
• Advanced knowledge of Regulatory or Compliance environment preferred

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

Previously, I was responsible for support and expertise to the Director of Pharmacy, Quality and other functional workteams related to the physical requirements and operation of the CAPS pharmacies in compliance with Federal and State regulations, as well as current USP <797>, USP <800>, and cGMP guidance.

Please consider my qualifications and experience:

• Demonstrated knowledge of organizational and business policies and procedures, processes and Government regulations
• Skill in use of basic inspection/measurement tools
• Typically has considerable experience in this area of expertise
• Experience of facility audits & exposure to various quality certification process
• Fluency in English/Proficiency in Excel
• Product Or Service Familiarization - Understanding of the product line or services of the specific business of which the person is a part (i.e., plant, performance cell, etc)
• Quality System Development, Implementation and Verification - Identify and integrate common elements such as design and process control, management responsibility, document control Quality auditing planning, preparation and execution
• Knowledge and full understanding of the J&J Quality Policy (POL 001), and the procedures and processes outlined in the BQM

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

Previously, I was responsible for leadership in the interpretation and implementation of various regulatory requirements and safety standards at the local, state and national level.

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 of, and exposure to, manufacturing processes and Quality metrics preferred
• Previous experience working with component or finished goods suppliers is desirable
• Strong data acquisition, analysis, and knowledge building skills
• Strong understanding of Quality metrics and calculations
• Excellent knowledge and understanding of the IT and IT services industry
• Strong understanding of the complexities of IT outsourcing
• Track record in a Senior Service/ Customer experience role
• Experienced in Quality Engineering areas documented