Director, Quality Systems Cover Letter

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

Previously, I was responsible for and ensure training delivery for the Oncology & Biologics Quality organization associated to relevant quality systems such as validation, change control and data integrity.

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 lubricant requirements for agricultural, construction, gas, diesel and industrial equipment
• Understanding of the lubricant blending processes
• Leadership experience managing and interacting with international organizations with diverse cultures and business operational needs, managing global teams / projects, and supporting solutions leveraged across multiple geographic regions
• Proven business leader who effectively communicates and “sells” ideas and solutions across all levels of the corporation, including system users, senior management, technical personnel and consultants
• Lean manufacturing techniques and process experience
• Preferred fields of study include Biology, Biochemistry, and Microbiology
• Strong understanding of cGMPs, FDA and EMEA regulatory standards
• Seasoned professional in managing GxP Quality Systems for drug/device combination aseptic products with a thorough knowledge of cGMP regulations (21CFR211, 21CFR820, 21CFR4, EU GMPs and Annexes), ISO 13485, ICH guidance’s

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

In the previous role, I was responsible for training as required to manufacturing personnel regarding change control and other relevant quality system processes or requirements.

Please consider my qualifications and experience:

• Participates in and provides meaningful direction for the hiring and selection process for laboratory analysts and managers
• Demonstrates appropriate financial stewardship by ensuring systems are in place for monitoring supplies and equipment needs
• Makes assignments and manages direct reports to serve as System Administrator for various laboratory instrument
• Knowledgeable in the validation and transfer of new methods into the laboratory
• Stays abreast of emerging general GMP industry trends and applications of laboratory instrumentation
• Participates in internal / external GMP audits and GMP walkthroughs of the Quality laboratory
• Able to hammer out tough agreements and settle disputes equitably, finding common ground and gaining cooperation with minimum noise
• Experience with FDA regulations as it applies to technology processes and systems

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

In the previous role, I was responsible for guidance in quality issue resolution, change control processes, customer complaint investigation and CAPA programs to assure GMP compliance in the development, implementation and maintenance of quality systems and activities, as well as the on-going evaluation of such systems implementation.

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

• Experience in oversight of implementing GxP computer systems with compliance to Part 11 and EU Annex 11 requirements
• Pro-active and identifying opportunities along with strong problem solving and negotiation skills
• CPHQ or like Certification preferred
• Knowledge of data structures and data reporting tools & techniques (e.g., Spotfire, Business Objects, MS Excel, Cognos etc
• Detailed knowledge and experience of working in a research and development environment
• Prior experience of working in an operations and or data analytics role
• Experience in developing and communicating business requirements
• Previous business redesign or change management experience preferred

Please consider me for the director, quality systems opportunity. I am including my resume that lists my qualifications and experience.

In the previous role, I was responsible for a quality review on a range of quality documentation including, SOPs, policies, guidelines, specifications, investigations, complaints, change controls, GMP records and other quality management systems documentation as required;.

Please consider my experience and qualifications for this position:

• Current Auditor Certification (CQA, ISO Lead Auditor, ) is strongly preferred
• Has good working knowledge of GMP's as they pertain to Active Pharmaceutical Ingredient manufacturing quality policies and procedures
• Reports to the Quality Operations Director for general advice and instruction concerning testing and release of raw materials, packaging components, and Active Pharmaceutical Ingredients
• Consults regularly with the Quality Operations Director who is to be kept adequately informed on the status of quality issues and projects
• Oversees completion of all testing activities within the laboratory section
• Manages on-time closure of deviation investigations
• Ensures compliance with all site and corporate quality, safety, and environmental policies and procedures
• Ensures all members of the group are properly trained and all mandatory compliance and SOP training is completed in a timely manner

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

In the previous role, I was responsible for leadership and oversight to support GMP quality systems elements, validations, change requests, investigations and corrective actions.

Please consider my qualifications and experience:

• Experience in working with and responding to IT audits
• Experience working in an IT/project management environment
• High level of expertise in customer relationship management design and implementations
• Technical and comprehensive knowledge of broad business areas
• Working familiarity with departmental applications
• Strong leadership, written and verbal communication, interpersonal and presentation skills to drive results
• Experience in operations, manufacturing, and/or R&D
• DBS operational excellence training or certification