Model Risk Analyst III - Validation
M&T Bank$82,783 - $137,972/year
Full Time
Mid-level (3 to 4 years), Senior (5 to 8 years)
Not SpecifiedCompensation
Mid-level (3 to 4 years), Senior (5 to 8 years)Experience Level
Full TimeJob Type
UnknownVisa
Healthcare, PharmaceuticalsIndustries
Requirements
- Bachelor’s degree in IT, Engineering, Computer Science or similar STEM qualification
- Minimum of 5+ years of experience in FDA-regulated industry in a Quality Assurance, Compliance or Computer Systems Validations role, leading and managing qualification efforts for GMP relevant applications
- Experience and knowledge with FDA regulations as they pertain to information and digital solutions, especially 21 CFR Part 11, as well as relevant aspects of corporate privacy requirements (preferred)
- Experience with risk-based approach to system validation and testing (preferred)
- Experience in the development and execution of computer validation documentation and standard operating procedures (preferred)
- Adaptability and flexibility to work in a fast-paced, dynamic environment and manage multiple tasks simultaneously (preferred)
- Ability to work independently, and on multiple concurrent project initiatives (preferred)
- Enthusiasm to learn and share ideas and solutions effectively with management and colleagues (preferred)
Responsibilities
- Lead validation activities for the applications
- Provide oversight and guidance on all aspects of the validation of the solution ensuring compliance with all government regulations and corporate policies and procedures
- Ensure compliance with internal and external privacy policies and requirements
- Leverage your knowledge and experience to shape the validation approach and strategy of the solution
- Provide guidance and oversight of computer systems quality and compliance activities, including the review and approval of computer systems validation deliverables as appropriate
- Build working understanding of configuration and integrations of the solution being implemented to ensure validation activities cover all requirements
- Influence design and testing decisions to ensure security and privacy risks are considered and mitigated
- Design effective, streamlined validation processes to accelerate solution delivery leveraging automated configuration verification and testing where possible
- Lead testing effort on system releases and changes ensuring system remains in a validation state
Skills
Key technologies and capabilities for this role
Questions & Answers
Common questions about this position
What are the basic qualifications for the Analyst - CSV role?
A Bachelor’s degree in IT, Engineering, Computer Science or similar STEM qualification is required, along with a minimum of 5+ years of experience in FDA-regulated industry in a Quality Assurance, Compliance or Computer Systems Validations role, leading and managing qualification efforts for GMP relevant applications.
What preferred skills are mentioned for this position?
Preferred skills include experience and knowledge with FDA regulations especially 21 CFR Part 11, a risk-based approach to system validation and testing, and experience in the development and execution of computer validation documentation and standard operating procedures.
What is the salary or compensation for this role?
This information is not specified in the job description.
Is this a remote position or does it require working from a specific location?
This information is not specified in the job description.
What does Eli Lilly's company culture emphasize?
Eli Lilly unites caring with discovery to make life better for people around the world, puts people first, gives best effort to work, and seeks determined individuals who contribute through philanthropy and volunteerism.
Eli Lilly and Company
Develops and delivers prescription medicines globally
About Eli Lilly and Company
Eli Lilly and Company is a global pharmaceutical company that focuses on discovering, developing, and delivering medicines to improve health. The company has a long history of scientific achievements, including the creation of insulin, the first life-saving treatment for diabetes. Lilly's operations involve extensive research and development to create new medications and enhance existing ones, ensuring they are safe and effective. Their products are primarily prescription medicines sold to healthcare providers for various medical conditions, including diabetes, cancer, and pain management. What sets Lilly apart from its competitors is its strong commitment to ethical practices and the protection of its products from counterfeiting. The company's goal is to enhance lives through innovative medical solutions while maintaining high standards of quality and ethics.
Indianapolis, IndianaHeadquarters
1876Year Founded
$1,180.1MTotal Funding
IPOCompany Stage
Biotechnology, HealthcareIndustries
10,001+Employees
Risks
Competition from Novo Nordisk's Ozempic may impact tirzepatide's market share.
Potential construction delays in Indiana could affect GLP-1 drug production timelines.
Regulatory challenges may hinder Kisunla's expansion in new Alzheimer's markets.
Differentiation
Eli Lilly's rich history includes the first life-saving insulin treatment.
Lilly's strategic partnerships enhance its position in neurodegenerative disease treatments.
FDA approval of Zepbound opens new therapeutic markets for sleep disorder treatments.
Upsides
Lilly's $9 billion complex in Indiana boosts GLP-1 drug production capacity.
Kisunla's approval in China expands Lilly's Alzheimer's treatment market in Asia.
Collaboration with EVA Pharma enhances Lilly's reputation as socially responsible.
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