Quality & Compliance Manager Cover Letter

I submit this application to express my sincere interest in the quality & compliance manager position.

Previously, I was responsible for expertise and guidance to Edwards facilities globally as needed regarding quality systems compliance, regulatory compliance and internal policies and procedures.

Please consider my experience and qualifications for this position:

• BSc - Science discipline
• Strong understanding of the establishment and use of KPIs and operational metrics to gauge and improve third-party vendor performance
• In-depth understanding of international pharmaceutical regulations and requirements governing the pharmaceutical industry
• Capable of analyzing a wide variety of information and data to make management decisions regarding potential risks associated with product quality and regulatory compliance
• Effectively lead and motivate a team of direct reports, builds on strengths, and address areas for improvement
• Able to establish/maintain professional relationships and rapport with internal and external peers and higher-level management
• Proficient in cGMPs, cGDPs and regulations promulgated by the FDA, EMA or equivalent regulatory Agencies
• Strong negotiating skills for interface with regulators and external Quality Assurance business

I submit this application to express my sincere interest in the quality & compliance manager position.

In the previous role, I was responsible for coordination and/or oversight for the following Quality Services and activities: Documentation Services, Internal Audits, Quality Systems, Quality Control, and Supplier Quality.

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:

• Environmental Science, Microbiology, Urban Planning, Environmental Engineering or equivalent
• Experience in the management of people, processes, technologies and budgets
• Sound knowledge of GxP and processes for Clinical Trial GMP Manufacture
• Strong Validation background
• Able to lead employees by providing technical and personal support
• Demonstrated flexibility to manage changing priorities
• Equivalent mix of education and experience is acceptable
• Lead Auditors Qualification

I submit this application to express my sincere interest in the quality & compliance manager position.

In the previous role, I was responsible for overall governance for quality management systems, policies and procedures, linking the organization together and providing the backbone for continual improvement.

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:

• Extensive related professional experience and long-term management experience
• Expertise in ISO 9001 and/or ISO 13485, and GMP requirements
• Strong expertise and practical experience with Project Management concepts, processes, skills, and tools
• Experience in managing budget, project plans, resource allocations and priorities
• Demonstrates significant knowledge and work experience in relevant Quality Systems functional areas, processes, and best practices, including CAPA management, Complaint Handling, Document Control, Change Control, QRB
• Successfully manage Structural safety related issues identified through the PPIRP (Potential Product Issue Resolution Process)
• Conduct plant level Compliance audits as assigned or scheduled based on ‘Risk” assessments
• Conduct New Product Safety Compliance audits a minimum of 60 days prior to identified Launch date for all Structures programs

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

In the previous role, I was responsible for quality management expertise to support the development, documentation and implementation of the Quality system within the ISO Certification.

Please consider my experience and qualifications for this position:

• Successfully manage JIT safety related issues identified through the PPIRP (Potential Product Issue Resolution Process)
• Complete read across activities based on operational lessons learned
• Conduct New Product Safety Compliance audits a minimum of 60 days prior to identified Launch date for all JIT programs
• Supervises other clinical laboratory staff
• Preventive Action/Operational Excellence (Green Belt/Black Belt) Certification
• Teamwork and Collaboration - Helps direct reports resolve their conflicts constructively
• Knowledge of science, theory and application of water/wastewater treatment and operations, water quality monitoring and quality assurance programs
• Knowledge of industry trade organizations to include participation in related activities aimed at improving environmental program awareness and stewardship opportunities

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

In the previous role, I was responsible for coordination and/or oversight for the following Quality Services and activities: Quality Systems, Complaint management, adverse event reporting and Service quality.

Please consider my qualifications and experience:

• Very high knowledge of Quality and Regulatory systems
• Knowledgeable of current risk management standards, principles and frameworks
• Experience in leading a Quality & Regulatory Compliance team and participating as part of an organisation’s leadership team
• Provide regular updates on team performance / capacity to Quality and Operations Management
• Assist with preparation and maintenance of department budget
• Identify and drives process improvements within Quality and OPS
• Analyze and report trends in audit findings or other quality metrics
• Host client and regulatory inspections