Manufacturing Director Cover Letter

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

Previously, I was responsible for thought leadership and expertise related to quality management and compliance, including an understanding of quality management best practices, industry trends, and governmental requirements.

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:

• BS in Engineering and/or any science discipline
• General problem resolution forday-to-day activities, customer quality issues, environmental compliance
• Strategic acumen and intellectual creativity and curiosity to develop executable ideas
• Influential collaborator who builds highly productive and respectful relationships across all levels of the organization as well with external partners
• An in depth knowledge of regulatory requirements for filing biologics in the US and Europe
• Knowledge related to mammalian cell bank, cell culture and purification manufacturing in depth knowledge of validation for a biologic manufacturing facility
• Demonstrated success as a strong team leader who uses past management and supervisory experience to develop departmental staff through effective feedback and coaching
• Direct experience with supporting 24/7 manufacturing operations is preferred

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

In the previous role, I was responsible for leaderhsip to management and direct reports on the Lean Six Sigma practices.

Please consider my experience and qualifications for this position:

• Related experience in production management, quality, sterilization processes, project management, and engineering, with a good grasp of industry regulatory requirements and best practices
• Proven track record in leading a cross-functional organization to exceed profit and operations goals
• Minimum BA or BS/MS Natural Sciences or Engineering, with MBA preferred
• Strong understanding of regulatory requirements (International Organization for Standardization (ISO 13485 and other associated or applicable standards)/applicable European Norm (EN) documents/ European Medical Device Directive (MDD)/ Canadian Medical Device Regulation (CMDR) standards/ applicable sections, Quality System Regulation (21CFR 820, 21CFR 11 and other associated or applicable FDA regulations), Japan Pharmaceutical Affairs Law (JPAL)
• Seeks multiple perspectives and listens openly to others’ points of view
• Enables and demonstrates the courage to speak up on issues and risks on the good news
• Comfortable in a fast-paced small company environment with minimal direction
• Vast knowledge of cGMP’s and experience with multiple regulatory inspection agencies such as EMEA and FDA

I submit this application to express my sincere interest in the manufacturing director position.

In the previous role, I was responsible for lean Six Sigma methodology training to employees including: Executives, Champions, General Management, Black Belts and Green Belts.

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

• Prior experience with aseptic biologics manufacturing
• Adept understanding of applicable 21CFR regulations (FDA), ICH Guidelines (EMA) and all other regulations applicable to Biologics manufacturing
• Proficient in MS Word, Excel and other relevant electronic systems
• Excellent critical thinking, time management and organizational skills
• Management experience in dairy manufacturing preferred
• Able to lead people and get results through others
• Knowledge of continuous improvement and process improvement techniques
• Strong knowledge and implementation of Compliance Management – cGMP, technical operations, and quality systems within a pharmaceutical manufacturing site is preferred

I submit this application to express my sincere interest in the manufacturing director position.

In the previous role, I was responsible for direction to multi-disciplinary project teams, regarding, lean six sigma, program management, and change management who are engaged on key company change programs.

Please consider my qualifications and experience:

• Significant professional experience managing at least at the division level
• Demonstrated history developing and implementing business strategies
• Appreciation for partnering with suppliers and clients to maximize supplier performance
• Experience managing cross-functionally in a matrixed environment
• Experience managing a multi-national, technical, salaried workforce
• Able to comfortably and clearly converse, write and read in English
• BS in Science or Engineering.MS is preferred
• Knowledge of medical device regulations, statistical sampling and analysis

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

In my previous role, I was responsible for oversight on all Lean Six Sigma projects both in an Agile and in a traditional environment.

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

• Lead and manage by influence
• Individual and team coaching
• Process focused leadership
• Develop next generation of leaders
• OB and RB budget commitments
• Productivity (units/labor hour)
• Overall Equipment Effectiveness (OEE2)
• Total Employee Involvement (TEI) for manufacturing and engineering functions