Manager, Quality Systems Cover Letter

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

In my previous role, I was responsible for quality Team support by promoting Good Manufacturing practices and supporting achievement of annual site objectives necessary to successfully produce and support products and services.

Please consider my qualifications and experience:

• Documented training in FDA Quality System Regulation (QSReg), ISO 13485 and MHLW Ordinance 169
• RCA trained
• Experience in IT, basic IT Systems Validation and its application to GMP processes manufacturing process laboratory and business systems
• Strong knowledge of training processes/systems and regulatory requirements (21 CRF Part 11/210/211)
• Good knowledge of GMPs
• Experience or knowledge of Change Control, CAPA and Audit practices/strategies
• Excellent customer focus, enabling strong collaboration with various department system owners and functional area managers
• Advanced skills with MS Office applications including Word, Excel, Access and Adobe Acrobat

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

In the previous role, I was responsible for advice on system development and integration and ensures that relevant technical strategies, policies, standards and practices are applied correctly.

Please consider my experience and qualifications for this position:

• Experience with systems and data analytics
• Expertise recognized in several fields related to quality system
• Bilingual (English/ French) preferred, fluent in French essential
• In depth understanding of GMP, familiarity with international regulations and guidelines
• Good understanding of vaccines or similar biologics raw material manufacturing technologies
• Demonstrated advanced knowledge of processes, standards and controls as they relate to the regulated health care or life sciences business
• Operational experience in the core QMS processes such as quality risk assessment, global document management, global change control, and deviation handling
• Knowledge of Quality best practices and experience with technology tools to support the advanced knowledge of TrackWise, SAP, and Lab Information Management systems preferred

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

Previously, I was responsible for iSO 13485 and FDA regulation guidance to all site disciplines.

Please consider my qualifications and experience:

• Well-developed interpersonal skills in order to motivate and lead the business cross-divisional teams
• Leads strategic Quality System initiatives
• Strong track record of successfully managing difficult tasks from start to finish
• Experience with ISO Standards in Medical Devices and process improvements
• Knowledge of Quality Assurance functions and practices
• Proficient in use of computer software
• Proficient knowledge of Continuous Improvement, Manufacturing Resource Planning, LP9000 and Total Productive Manufacturing (TPM) concepts
• Intimate knowledge of the manufacturing process

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

Previously, I was responsible for guidance to ensure that job training practices are compliant with FDA and ISO requirements.

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

• Experience in pharmaceutical or biotech industry preferred
• Knowledge/understanding of FDA regulations, ISO standards, and other industry standards for Medical Devices
• Good knowledge of Statistical techniques, investigation techniques (5 Why’s, Ishikawa, etc), Quality Assurance principles, team functions, leadership techniques and project management methodologies
• ASQ, CQE, and CQA Certifications preferred
• Operations environment or pharmaceutical Quality Assurance role
• Strong demonstrated knowledge of cGMPs, Quality Systems and the pharmaceutical supply chain environment
• Demonstrated experience working cross-functionally and managing significant improvement initiatives
• Strong problem solving, negotiating/influencing skills

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

In the previous role, I was responsible for subject matter expert support during Good Manufacturing Practices/Good Distribution Practices audits, regulatory agency inspections.

Please consider my experience and qualifications for this position:

• Work with the Director of Quality to establish effective Management Reviews
• Oversee improvement QMS plans to ensure the integrity of our QMS while the improvements are being implemented
• Work with Lighting’s Quality Department to ensure coordination of quality systems, processes and protocols
• Deliver presentations to a technical audience
• Experienced in performance management and development planning
• A strong communicator who is able to work with all levels of the organization
• Excellent knowledge of Good Manufacturing Practice as described in current FDA & EMEA regulations for non-sterile, sterile and biological pharmaceutical manufacture
• Qualified Person status is highly desirable but not essential