Validation analyst job description

Sr Quantitative Model Validation Analyst

Location
Headquarters-Troy, MI

Job Summary
The senior analyst will conduct model validation activities as required per interagency guidance OCC 2011-12 and SR 11-7. The senior analyst will perform technical assessment of adequacy of the modeling data and assumptions, conceptual soundness, mathematical formulation, and model performance, as well as the assessment of using the model for regulatory and business applications. The senior analyst will accomplish this by performing quantitative validation testing and developing challenger models, discussing and remediating findings, writing validation reports, and assessing ongoing model performance monitoring. The senior analyst will also mentor junior staff validators and act as a project manager for validations performed by external validation service providers. The analyst will also support the Volcker Compliance Oversight function at the Bank.

Job Responsibilities:
Leverage advanced quantitative skills (like applied statistics) to perform model validations for models used for managing interest rate, market, margin, credit and operational risks; valuing securities portfolios and financial instruments; performing econometric forecasting and capital stress testing; monitoring customer activities for fraud and anti-money laundering; and analyzing opportunities for marketing campaigns. Validation includes providing effective challenge to model assumptions, mathematical formulation, and model implementation, writing reports documenting the results, communicating validation results to senior and executive management, and tracking the resolution and remediation of validation issues.Manage model risk for the Bank as per regulatory guidance (OCC 2011-12; SR 11-7). The role requires managing model risk by continual tracking of models in use at the bank, proper application and use of model in order to not subject the Bank to undue or unidentified risks. The role requires maintaining and enhancing the Bank's internal policies and procedures to comply with the Model Risk Management guidance and performing model risk and ongoing monitoring assessments. The role also requires mentoring junior staff, including reviewing and approving their work and to act as a project manager for any third party validations.Support the Bank's Volcker Compliance oversight functions as needed. The task requires a general working knowledge of the Volcker Rule and how it pertains to the Bank and testing of operational risk controls.Adhoc initiatives (as required) Ensures compliance with applicable federal, state and local laws and regulations. Completes all required compliance training. Maintains knowledge of and adhere to Flagstar's internal compliance policies and procedures. Takes responsibility to keep up to date with changing regulations and policies.

Job Requirements:
Bachelors Degree: Finance, Accounting or Economics RequiredMasters degree in Finance, Accounting or Economics is strongly desired Chartered Financial Analyst (CFA), Financial Risk Manager (FRM) or working towards other similar certification strongly desired Model Development, Usage, or Validation required

Required:
3 to 5 years of Model Risk Management3 to 5 years of strategic planning, forecasting, financial analysis, or econometric modeling in the Banking Industry Advanced quantitative skills, especially in applied statistics (through a Masters or a certification program) Bachelor's degree in Economics, Finance, Mathematics or similar education Ability to work effectively in a fast-paced environment with multiple deadlines and competing priorities Capability to produce clear, concise written work products (e.g., validation reports, white papers, memos and presentations) and communicate the results to senior and executive management.Credit, treasury, or statistical modeling exposure Demonstrated critical thinking and analytical skills Outstanding written and verbal communications skills Ability to work autonomously, handle multiple projects simultaneously and consistently meet deadlines Ability to collaborate closely with model owners and other members of the team Strong organizational skills with close attention to detail Mentor junior staff validators and review their work.Act as a Project Manager for validation performed by external validation service providers

Desired:
Advanced degree in Economics, Finance, Mathematics or similar education Background in Mortgage Banking, Community Banking, Enterprise Risk, or Internal AuditModel validation experience in the following functional areas: Mortgage Originations, Mortgage Servicing, Retail Banking, Commercial Lending, Treasury, Enterprise RiskPrior experience in collaborating with regulators, auditors, and compliance including familiarity with OCC 2011-12Technical background with ability to comprehend model source code in a multiple coding languages General familiarity of the Volcker RuleWorking knowledge of financial markets

Internal Use Only: Band E

Baxter’s products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.

Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.

Join us at the intersection of saving and sustaining lives— where your purpose accelerates our mission.

Summary
This position is responsible for the development and the execution of projects which include engineering studies, validation protocols and revalidations of manufacturing facilities, equipment, utilities, computerized systems, cleaning methods, sterilization methods, and processes. Validation activities include research, protocol writing/execution and final report generation. Additionally, investigations of manufacturing challenges are conducted and process improvements are evaluated/implemented. Final documents are archived and may be included in or support A/NDA submissions, and made available as needed during FDA, MHRA, and client/customer compliance audits. Must not be allergic to Cephalosporins or Penicillin.Essential Duties and Responsibilities:

• Be involved in design of experiments, development of new methodologies and improving existing methodologies, data generation, report development and presentation.
• Schedule, plan, communicate, and manage documents and follow-up on validation activities. Interpret and apply regulatory requirements concerning validation activities.
• Applies knowledge or quickly learn cGXPs, relevant SOP curriculum, routine project procedures, project management, and other training as appropriate.
• Perform validation activities to lead and/or support cleaning, equipment, computer systems, utility, facility, sterilization, and method validations. Support setting requirements for controlled work requests.
• Review and generate quality documents including validation protocols, SOPs, change controls, and non conformance event records as required.
• Serves as a project lead for projects of intermediate scope with cross-functional teams.
• Support regulatory inspections and responses as required.
• Able to prioritize workload and tasks. Ability to follow good project management practices to meet schedules while ensuring compliance with procedures and regulations.

Qualifications

• Understand scientific strategies and be able to invent new methods or new avenues of investigation.
• Good interpersonal/communication/influencing/negotiation skills.
• Good project management skills
• Ability to communicate effectively at all levels in verbal and written form, including technical/business writing.
• Proficient in Microsoft Word and Excel, computer software. Some experience with statistical software helpful.
• Direct or indirect industry knowledge.
• Ability to work independently or in teams.
• Physical demands of the position may require the ability to lift materials up to 20 lbs, dexterity to gown, mobility to maneuver around equipment, and enter into confined spaces without restrictions.

Education and/or Experience

• BS Degree in Science, Engineering or Math with 2 or more years experience. Masters Degree with 1 or more years experience.
• At least 1 year of direct experience with writing and executing validation protocols is preferred.
• Experience in Sterility Assurance/Sterilization Engineering desired, but not required

#IND-USOPS#LI-DM1

The successful candidate for this job may be required to verify that he or she has been vaccinated against COVID-19, subject to reasonable accommodations for individuals with medical conditions or religious beliefs that prevent vaccination, and in accordance with applicable law.

Equal Employment Opportunity

Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

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Reasonable Accommodations

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information.

Recruitment Fraud Notice

Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice.

081563

• Consult project/client needs wrt validation and 21 CFR Part 11 GXP compliance testing procedures
• Performing Compliance evaluation of procedures and systems wrt equipment, facilities and computerized systems used in GLP, GMP and GCP environments.
• Coordinate with cross-functional project teams in for deliverables within the agreed timeline.
• Support development of best practices within the validation group, based on current industry practices and guidelines.
• Required to be on the site in Chicago, IL or nearshore supporting Chicago time zone

Key responsibilities

• Serve as quality representative and compliance resource, directing the application of company standards for internal validation activities, including quality review and approval of project deliverables
• Using in-depth professional knowledge, provide guidance to employees, external contractors, clinical investigators, and development partners on complex topics related to computer system regulatory requirements, data integrity, and quality systems
• Direct and train staff on regulatory requirements, quality management processes and procedures, and inspection readiness

• Conduct periodic assessment activities to ensure systems are operating in a compliant state and foster continuous improvement
• Collaborate with functional teams to ensure that the integrity of data and information is maintained throughout its lifecycle
• Quality Assurance/Audits
• Commensurate with expertise, plan and conduct internal and external audits of technology in use by customer and tool vendors providing computing services
• Guide functional teams through the deviation/CAPA process to ensure robust investigation, timely action, and meaningful improvements to process
• Using quality management system tools, analyze audit findings and deviation trends to drive continuous improvement
• Collaborate with external contractors conducting audits on behalf of customer. This may include co-auditing activities, providing information about company processes, known quality issues, audit scoping expectations, and/or guidance on use of the audit system
• Conduct or participate in Mock Regulatory Inspection activities and/or provide guidance to functional teams to facilitate inspection readiness
• Special Projects, Other Responsibilities as assigned

Work experience & skills

• Familiarity with GxP systems (POMSnet, Maximo, OSI PI, SampleManager, Empower, Trackwise, ComplianceWire, Antares, Warehouse Serialization Solution, Discoverant)
• Experience with Kneat (App Change Management), qTest (ALM), & Tosca (automated testing)
• Knowledge of FDA and European compliance regulations and GAMP guidelines applicable to computer system validation.
• Familiar with off-the-shelf, configurable, and custom-developed applications validation.
• Experienced with various technologies and automated systems used in the pharmaceutical industry - Business System (ERP etc), Quality System (Track wise, LIMS etc), PLC or SCADA, Process Control, Laboratory Instrumentation, Data archive/historian, etc
• Excellent oral and written communication skills in English. Strong expertise and ability to interview and accurately interpret communication requirements of team members.

Academic & trades qualifications

• Bachelor's degree in engineering / Master's Degree in science.
• Total 5 years' of relevant validation testing experience with a minimum of 3 years or more experience in Validation testing.
• Experience in pharmaceutical/biotech manufacturing or testing is an added advantage