Validation Manager Cover Letter

I submit this application to express my sincere interest in the validation manager position.

In the previous role, I was responsible for support and guidance to the Quality organization and site leadership regarding enhancement of cGMP compliance and quality performance improvements.

Please consider my experience and qualifications for this position:

• Management and Quality Records Management
• Validation experience in a biotech/pharmaceutical environment, specializing in Computer System Validation
• Experience leading teams in a dynamic fast paced work environment
• Experience in Credit Risk Models (PD, LGD, EAD, ECAP) or Operational Risk Models, and/ or Market Risk Models and/ or CCAR models and framework
• Experience in model development and/or model validation
• Strong knowledge of financial mathematics and applied statistics • Relevant Professional Certification (FRM/ PRM, CFA or equivalent) preferred
• Significant validation experience within a GMP environment
• Demonstrable validation experience in a medical device ISO13485, Pharmaceutical (chromatography, ELISA), consumer healthcare or related industry

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

Previously, I was responsible for guidance to Model Integrity Team, model owners, and Actuarial Model Governance Team to enhance model validation and model change management process and reporting.

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:

• MS / BS in Engineering or Technical discipline
• Competent with cGxP requirements and best practises, including FDA, EU and GAMP
• Knowledge of project and program management disciplines, methodology and tools
• Manufacturing experience at a GMP site preferred
• Dedicated to quality customer service and proactive and responsive to customer needs
• Experience in design, verification or validation disciplines, system level debug and root cause isolation, methodology and tools
• Experience with CPU architecture or FPGA architecture/design flows
• Experience with delivering complex projects on schedule and working collaboratively across teams/organizations to deliver business results

I submit this application to express my sincere interest in the validation manager position.

Previously, I was responsible for site stakeholder feedback to drive improvements to global initiatives, including the Pharmaceutical Quality System and Quality Risk Management program.

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:

• Safety standards and hazard management experience
• Demonstrated leadership within complex and multinational organisational set-up, including resource management, budgeting and planning
• Excellent global communication skills, both oral and written
• Understanding of quality systems and Gauge R&R, MSA processes
• Broad understanding of Automotive OEM validation and EMC specifications, and how it pertains to suppliers products
• Expert understanding of environmental, mechanical, and EMC testing practices specifically pertaining to the Automotive industry
• Experience in the NAND flash based storage industry
• Experience of software and test development methodologies

I submit this application to express my sincere interest in the validation manager position.

Previously, I was responsible for training and guidance to model validation testers, help to resolve or escalate issues, and raise any concerns to Model Risk Management leadership.

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

• Strong SAS and SQL (or similar language) programming skills
• BS in Chemistry, Biology, Engineering or Pharmacy
• Solid knowledge of the validation principles and concepts for process, cleaning, computer systems and facilities/equipment qualification
• Thorough knowledge of the cGMP regulations
• Fluence in Spanish will be an asset
• Fluence in Spanish is preferred
• Experience in a cGMP environment is an asset
• Excellent written and verbal communication skills including presentation skills in English and Dutch

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

In my previous role, I was responsible for guidance to the validation team in establishing policies, procedures, and strategies consistent with cGMP, International guidance, and the Company’s Quality Programs.

Please consider my qualifications and experience:

• General computer knowledge MS-Windows, MS-Office,.
• Should have passed an advanced driver training
• Long term experience in engineering, f.e
• Personnel and team management experience welcome
• Experienced in driving on proving grounds
• Applied knowledge of cGMP regulations and guidelines
• Able to handle complex technical and people issues as they arise
• Experience with interacting with regulators