External Manufacturing Cover Letter

I am excited to be applying for the position of external manufacturing. Please accept this letter and the attached resume as my interest in this position.

Previously, I was responsible for support for ensuring, improving and maintaining compliance with FDA and other related government regulations, company QMS requirements and any other requirements defined by the company.

Please consider my qualifications and experience:

• Form strong partnerships with Operations and Quality functions to organize technical support to meet quality, cost, and lead time goals for the CMO site
• Develop strong collaborative relationships with CMO site leadership and staff in order to understand short term and long term risks at the site
• Bachelor of Science in Materials Science, Electrical or Mechanical Engineering, related field of study
• Proven experience of the GxP environment in the pharmaceutical sector
• Extensive knowledge of GMP regulations and regulated environments is a requirement
• Understanding of the complexities of a global business with some international experience or having held a role with broad geographical scope
• Solid project management experience to enable effective leadership of projects and teams
• Partner with commercialization/product development functions within MSD and organize the technology transfer of products to that site

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

Previously, I was responsible for high quality design output that meet all requirements of valid standards, regulations, our quality system regulations and PDM-system-integration.

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:

• Experience using Statistical Analyses
• Knowledge of worldwide regulatory requirements, experience supporting regulatory inspections
• Strong analytical problem solving skills, root cause analysis
• Proficiency in French would be a distinct advantage
• Possesses a strong understanding of manufacturing concepts
• Willing to work long hours if needed
• BS/BA with Scientific focus (or equivalent)
• Previous contractor management experience

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

In my previous role, I was responsible for visibility on new Health Authority regulations or changing expectations and results of Health Authority inspections.

Please consider my qualifications and experience:

• Experience managing Subcontractors or Material Suppliers
• Knowledge about Procurement, Manufacturing, Logistics, Supply Chain
• Experience with biologic/vaccine Quality Assurance, SAP based MRP platform and Trackwise change control and customer complaint applications is preferred as is some level of contractual and financial awareness
• Experience working in Consumer Goods, Pharmaceutical, and/or Medical Device industries is highly preferred
• Driving performance in terms of EHS & Quality compliance and other applicable J&J policies
• Ensure for the EMs in charge the associated Account Plans are set, aligned with key stakeholders and executed
• Strong technical knowledge of sterile manufacturing technology and processing techniques
• Working knowledge of Master Service, Technical and Quality Agreements

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

Previously, I was responsible for manufacturing Engineering support for Quality and MDR compliance activities including correcting quality problems in released product, compliance with the new regulations and standards, support for Regulatory re-submissions, and remediation of quality records.

Please consider my qualifications and experience:

• Familiarity working in global change control systems
• Experience performing root cause analysis and utilizing six sigma tools
• Knowledge of worldwide regulatory requirements for pharmaceuticals and biological products
• Proficiency in French or German would be a distinct advantage
• Project Management and Basic Statistical Analysis experience
• Sterile power filling experience would be a distinct advantage
• Proficiency in Italian would be a distinct advantage
• Manufacturing experience in sterile/ aseptic processing or formulation and filling

I am excited to be applying for the position of external manufacturing. Please accept this letter and the attached resume as my interest in this position.

In the previous role, I was responsible for functional leadership and management to a team of salary leads and technicians, and ensure compliance with RMD directives and industry regulations.

Please consider my experience and qualifications for this position:

• Strong problem solving and statistics skills
• Strong teamwork and consensus building skills
• Confident and effective communication skills with senior leaders and cross functional business partners
• Strong Project / Program management skills will be preferred
• Fluent with in-depth understanding in planning, demand/forecast, forward cost modeling, product deliveries and inventory management
• Strong communication skill trait, and proven track record of risk management and drive cost improvement in our external manufacturers
• Fluent in Mandarin Chinese, Taiwanese and Proficient in Japanese
• Needs to analyze supplier and economic markets