Director, Quality Control Cover Letter

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

Previously, I was responsible for information regarding Quality Control systems and data to internal or external regulatory personnel during inspections or inquiries.

Please consider my experience and qualifications for this position:

• Technical football knowledge
• Experience in managing a Quality System within a Pharmaceutical environment
• Manage day to day quality control activities, project management, workforce planning, training and budgeting
• Assist in managing budget department and approval of expenses
• Oversee daily operations of global quality control centers
• Oversee all certification of software
• Knowledge and understanding of testing methodologies and able to manage and implement new processes
• Knowledge of SDLC and software testing cycles

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

In the previous role, I was responsible for statistical leadership for preparation of marketing applications (e.g., NDA/BLA) to FDA, EMA, or other worldwide regulatory agencies and other regulatory submissions (such as IND safety update, PSUR).

Please consider my qualifications and experience:

• Previous experience with biological products in an FDA regulated environment
• Strong educator that is able to convey complex information and ideas easily
• Pro-active, strategic thinker who is results oriented while taking the long term view
• Leading a significant business unit of similar size
• Possess a strong and current knowledge of cGMP compliance and maintain strong cGMP Compliance in the activities of the Chemistry function
• Requires BS/BA in cell biology or biochemistry, or related field
• Requires strong CMC background, analytical and writing skills, and hands-on experience
• Strong knowledge of cGMP regulations, building codes, safety and environmental requirements

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

Previously, I was responsible for sME input for IND, BLA and other technical documents for regulatory agency submissions in support of manufacturing processes operated at CMOs.

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 in Debit/Credit processing and ATM processing
• Aerospace/Aviation Defense and Commercial quality experience (customer and regulatory requirements, detail parts, assembly, special processes, inspection, assembly/test, repair/overhaul)
• Strong technical knowledge of method development, performance, optimization and qualification in a broad array of in vitro assays, combined with outstanding analytical and data interpretation skills
• Experience with evaluation of nucleic acid therapeutics
• Strong independent judgement and decision making abilities
• Demonstrated problem detection and resolution skills
• BS or MS in Chemistry, Biochemistry or related scientific field
• Experience with small molecules, managing analytical laboratories engaged in testing in support of product development in a GMP environment

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

In the previous role, I was responsible for strong leadership for a cGMP Quality Control testing laboratory within a commercial vaccine manufacturer.

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:

• Strong knowledge of chemistry with proven analytical and problem solving skills
• Solid and demonstrable knowledge and understanding of US and international
• Recent experience in preparation of CMC sections of US or EU regulatory filing is highly desirable
• Basic concept of scientific theories, principles, and techniques used in analytical test procedures
• Ensure compliance with all applicable regulations, standards, systems, procedures
• Report out on product quality metrics no less than quarterly
• Perform duties associated with being a member of Lab Management team, including
• Extensive GMP laboratory management within a multi-national pharma/biopharma company is essential

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

In the previous role, I was responsible for oversight and quality support on Global Lab Automation Systems project (Pre-approval and post execution review and approval of protocols, SOPs, etc.).

Please consider my experience and qualifications for this position:

• Proven track record and established leadership in biological and small molecule analytics applied to clinical drug development and GMP manufacture
• Interact with QC Leaders in each plant within the Canadian region, supporting the plant needs by answering questions regarding raw materials, formulas, packaging, QA Manual procedures, SAP QM, SAP PLM, and other relevant subject matter
• Facilitate weekly conference call with plant QC Leads within the region to manage day-to-day quality issues, review MIP/quality data, and discuss WCO quality goals
• Monitor plant compliance and adherence to all QA procedures and standards, regulations, and documentation
• Review raw material, component, and product specifications on a regular basis to ensure alignment between plants, suppliers, co-packers, Corporate Quality, and R&D
• Review SAP QM data and Voice of the Consumer information for the region to identify issues and opportunities for improvement
• At a minimum of every 2 months conduct internal plant audits of quality procedures, including inspection of proper paperwork, testing and additive equipment, and product analysis
• Facilitate supplier management programs within the region to ensure high quality raw material inputs, including supplier audits and scorecards