Total 3 Senior Executive level Quality Assurance / Control job vacancies in Aurora Municipal Center

What Quality Assurance contributes to Cardinal Health
Quality develops and implements quality policies, procedures, and processes to ensure products and services comply with regulatory standards and specifications.

Quality Assurance develops and implements a compliant and cost effective quality system that assures products and services are reliable, safe and effective. This job family provides oversight of production/manufacturing activities, training to operational and quality control personnel, and educates business leaders on Quality policies and procedures and ensures that all products and services are properly reviewed for quality and documented.

Responsibilities

• Quality Assurance responsibilities include, but are not limited to, cGMP documentation review related to product release, facilities and equipment, material controls, laboratory controls, packaging and labeling, and production and process controls.
• Establish and report metrics related products and processes.
• Establish and maintain quality control procedures.
• Assist in determining types of tests to be performed as well as documentation and reporting requirements.
• Champion Quality, cGMP compliance, and EHS/Radiation Safety practices.
• Actively partner with plant management and personnel in troubleshooting quality deficiencies and implement corrective measures to eliminate quality problems.
• Assures quality events are complete and accurate and resolved in a timely manner that meets the expectations of applicable quality agreements.
• Ability to network across business and functional units to achieve positive outcomes.
• Able to challenge, appropriately, the design, conduct, and reporting of GMP activities including metrics and annual reporting. In that context, has the knowledge of the production process of the product.
• Understands technical/release product issues and evaluates their potential impact on product quality and compliance.
• Provides ideas for continuous improvement of the cGMP Quality Management System.
• Escalates complex issues to management in a timely manner.
• Prioritizes and ensures work is delivered in an efficient way.
• Performs other job duties as assigned.

Qualifications

• Bachelor’s of Science preferred – Chemistry degree highly preferred or equivalent work experience preferred
• 2+ years’ experience in a regulated environment preferred, pharmaceutical experience preferred.
• Possess an understanding of cGMP/compliance requirements for 210/211 preferred.
• Strong attention to detail.
• Ability to manage timelines and priorities.
• Ability to work independently with minimum guidance.
• Ability to multi-task.

Schedule

• Onsite in Aurora, CO. Typically, Monday-Friday between 8:00 am-5:00 pm. Candidate must be available to work weekends to provide coverage at site. Weekend work will be limited.

Physical/ Mental Requirements

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

• While performing the duties of this job, the employee is regularly required to talk or hear. The employee is frequently required to stand; walk; use hands to finger, handle or feel; and reach with hands and arms; balance; stoop, kneel, crouch or crawl; and talk or hear. The employee must occasionally lift or move up to 25 pounds.

Work Environment

• The primary work environment consists of an office, warehouse, and production environments within a radiopharmaceutical manufacturing facility. Employees handle radioactive materials and are exposed to very low amounts of radiation that are deemed safe by current standards.  The facility is operated under well-controlled and closely monitored conditions that are regulated by both State and Federal agencies, and that are enforced by the corporate internal quality and regulatory groups. Each staff member will receive specific training in keeping radiation exposures within regulatory guidelines and he/she will be routinely monitored for their exposure to radiation. Noise levels are considered low to moderate.

What is expected of you and others at this level

• Applies working knowledge in the application of concepts, principles and technical capabilities to perform varied tasks
• Works on projects of moderate scope and complexity
• Identifies possible solutions to a variety of technical problems and takes action to resolve
• Applies judgment within defined parameters
• Receives general guidance and may receive more detailed instruction on new projects
• Work reviewed for sound reasoning and accuracy

Anticipated salary range: $74,500-$106,400

Bonus eligible: No

Benefits: Cardinal Health offers a wide variety of benefits and programs to support health and well-being.

• Medical, dental and vision coverage
• Paid time off plan
• Health savings account (HSA)
• 401k savings plan
• Access to wages before pay day with myFlexPay
• Flexible spending accounts (FSAs)
• Short- and long-term disability coverage
• Work-Life resources
• Paid parental leave
• Healthy lifestyle programs

Application window anticipated to close: 05/11/2024 *if interested in opportunity, please submit application as soon as possible.

Candidates who are back-to-work, people with disabilities, without a college degree, and Veterans are encouraged to apply.

Cardinal Health supports an inclusive workplace that values diversity of thought, experience and background. We celebrate the power of our differences to create better solutions for our customers by ensuring employees can be their authentic selves each day. Cardinal Health is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, ancestry, age, physical or mental disability, sex, sexual orientation, gender identity/expression, pregnancy, veteran status, marital status, creed, status with regard to public assistance, genetic status or any other status protected by federal, state or local law.

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The End-to-End lead for Risk Mgt Report – Scoping, Data Acquisition, Sampling and Profiling will be responsible for the end-to-end transaction testing process for prioritized reports, including planning, scoping, sampling, test execution and observation validation.  This lead will work closely with Risk and Management Report use case owners, Functional Chief Data Officers (FCDOs) and Global Functions Technology (GFT) to adopt, execute transaction testing cycles and ensure adherence to the Transaction Testing Operating Model.

Success for this lead is to effectively and efficiently plan and lead testing cycles aligned to the Transaction Testing Multi Year Plan and Operating Model, testing data reported to regulators match their original source values, and conform to reporting requirements to identify areas which may require stronger data quality controls or compensating measures.

Key Responsibilities:

• Report transaction testing reviews for a book of work
• Sr analysts supporting transaction testing reviews including prioritizing work, providing guidance throughout cycles, developing analysts’ testing skill set, report and product knowledge through training on cycle scope. 
• Partner with GFT, Business Technology, Report Owners, FCDOs and external consultants in leading transaction testing cycles aligned the Transaction Testing Operating Model.
• Identify issues and exceptions, produce executive quality reports, analysis and insights, coordinate handoffs and communicate updates and results effectively to manager and stakeholders
• Support Root Cause Analysis in collaboration with GFT, Data Providers, Report Owners, FDCOs
• Ensure adherence to relevant policies, standards and operating procedures pertaining to Transaction Testing E2E Process

Responsibilities:

• Contributes to the Data Governance, Data Services and Data Quality initiatives across the organization.
• Participates in efforts to ensure Risk and Finance comply with the Citigroup Data Management Policy
• Assists in centrally acquiring all data related to Risk and Finance management and regulatory reporting processes while ensuring data quality, completeness and consistency across the organization.
• Helps prepare and review monthly financial summaries and monthly business reviews for senior management that clearly communicate the financial performance of the business
• Designs, implement, and monitors key performance indicators and metrics
• Drives process improvement opportunities that enhance the efficiency of the financial reporting cycle while also increasing the informative value of the content provided to senior management
• Leverages technical expertise to execute quantitative analyses that translates into actionable insights for management
• Has the ability to operate with a limited level of direct supervision.
• Can exercise independence of judgement and autonomy.
• Acts as SME to senior stakeholders and /or other team members.
• Appropriately assess risk when business decisions are made, demonstrating particular consideration for the firm's reputation and safeguarding Citigroup, its clients and assets, by driving compliance with applicable laws, rules and regulations, adhering to Policy, applying sound ethical judgment regarding personal behavior, conduct and business practices, and escalating, managing and reporting control issues with transparency.

Qualifications:

• Project Management experience
• 5-8 years relevant experience
• Strong quantitative/analytical skills
• Proficient in Microsoft Excel and Microsoft Power Point
• Clear and concise communication and relational skills
• Ability to manage multiple projects and deadlines
• Strong project management skills

Education:

• Bachelors degree

Additional Responsibilities may include:

• Support process transformation, Consent order initiative and automation opportunities.
• Support the standardization of Citi’s Transaction Testing Operating Model, Cycle Execution and Work Papers
• Support Internal Audit, ICRM, ORM and Regulatory testing Reviews for Risk Mgt and/or other Regulatory reports.
• Updating KPIs, metrics, and other presentations, identifying enhancement opportunities and implementing, and supporting manager in the messaging of results/value add to senior management
• Facilitating ad hoc, special requests and project management

The ideal candidate will have the following education, knowledge and experience:

• Bachelors / University Degree in Finance, Accounting or related field
• Three tiers of primary subject matter knowledge required:
  • CCAR or Regulatory experience with key regulatory reports for banking organizations (e.g., FR Y-14, FR Y-9C, Call Reports, FFIEC 009, etc.)
  • Knowledge of Bank Products
  • US GAAP Knowledge
• Quality Assurance transaction testing experience required
• 7+ years of experience in Quality Assurance and / or Regulatory Reporting in financial services including proven experience in complex operational environments
• Ability to collaborate, coordinate and execute with the broader teams, business partners, Report Owners, Data Providers, technology and global functions to drive successful execution of testing cycles
• Well-developed organizational, analytical and problem-solving skills, aligned with excellent attention to detail and time management
• Strong ability to communicate ( oral and written) clearly to both technical experts, non-technical business leaders in order to facilitate cycle discussions with stakeholders and to clearly articulate findings, defend point of view amongst various groups
• Experience in working in a unit requiring coordination across multiple regions and business segments to deliver in a global organization
• Adaptable, flexible, Agile and able to respond to changes in priorities.
• Continuous improvement mind-set
• Possess strong team building, planning and project management skills
• Must be a proactive and goal-oriented strategic thinker, with ability to identify creative solutions.
• Proficiency in Microsoft Office, working with big data and proven ability to learn and utilize new tools and systems

This job description provides a high-level review of the types of work performed. Other job-related duties may be assigned as required

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Citi is an equal opportunity and affirmative action employer.

Qualified applicants will receive consideration without regard to their race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

Citigroup Inc. and its subsidiaries ("Citi”) invite all qualified interested applicants to apply for career opportunities. If you are a person with a disability and need a reasonable accommodation to use our search tools and/or apply for a career opportunity review Accessibility at Citi.

View the "EEO is the Law" poster. View the EEO is the Law Supplement.

View the EEO Policy Statement.

View the Pay Transparency Posting

Serves as a senior Bank Regulatory compliance risk officer for Independent Compliance Risk Management (ICRM) responsible for establishing internal strategies, policies, procedures, processes, and programs to prevent violations of banking law, rule, or regulation and design and deliver a risk management framework that maintains risk levels within the firm's risk appetite and protect the franchise. In addition, engages with the ICRM product and function coverage teams to develop and apply CRM program solutions that meet legal entity, business and product needs in a manner consistent with the Citi program framework.

This senior level position is on the Bank Regulatory Compliance team, referred to within ICRM as Bank & Financial Holding Company (BFHC). The BFHC team covers bank and financial holding company regulations, including but not limited to:

• Regulation K, international banking operations;
• Regulation O, insider lending;
• Regulation R, bank securities activities;
• Regulation L, bank interlocks;
• Regulation Y, acquiring assets in connection with debts previously contracted;
• Regulation Y, merchant banking investments;
• Regulation Y, anti-tying prohibitions; and
• Regulation W, inter-affiliate transactions.

The BFHC team is an enterprise area of coverage, interacting across Citi's five business areas (Banking, Markets, Services, Wealth, and U.S. Personal Banking), as well as across all support and control functions (Finance, Risk, Legal, HR, Operations & Technology).

The BFHC team is a multi-faceted function managing policies, trainings, horizontal compliance risk assessments, regulatory change, escalations and issue management, and control performance oversight. The team participates in business governance routines and provides subject matter expert advisory services for businesses and functions.

This role serves primarily as the Regulation O team lead. The role requires working with and providing compliance advice to Citibank, N.A. Insiders (directors and senior executives) and to businesses that provide lending products to Insiders. Additionally, the role requires overseeing two ICRM team members dedicated to executing ICRM-owned roles and responsibilities for Regulation O compliance.

Responsibilities:

• Designing, developing, delivering and maintaining best-in-class Compliance, programs, policies and practices for ICRM.
• Translating ICRM strategy and goals across Citi’s clients, products and geographies in a succinct and clear manner; provide direction and guidance on the programs. Serves as a subject matter expert on Citi’s Compliance programs.
• Providing oversight and guidance over the assessment of complex issues, structuring potential solutions and driving effective resolution with other stakeholders.
• Identifying and assessing Citi’s key compliance risks. Ensuring compliance risks within Citi are effectively identified, measured, monitored, and controlled, consistent with the bank’s risk appetite statement and all policies and processes established within the risk governance framework.
• Monitoring adherence to Citi’s Compliance Risk Policies and measuring compliance risk through a robust control framework and ensuring that reviews are conducted consistently across each entity on a regular basis to confirm that controls identified are operating effectively.
• Performing complex analyses of comparative data, preparing and presenting regional and global reports related to compliance risk assessments, and monitoring of compliance related issues.
• Partnering, collaborating and working with other areas within Citi, as necessary.
• Keeping abreast of regulatory changes, new regulations and internal policy changes in order to further identify new key risk areas.
• Additional duties as assigned.
• Appropriately assess risk when business decisions are made, demonstrating particular consideration for the firm's reputation and safeguarding Citigroup, its clients and assets, by driving compliance with applicable laws, rules and regulations, adhering to Policy, applying sound ethical judgment regarding personal behavior, conduct and business practices, and escalating, managing and reporting control issues with transparency.

Qualifications:

• Expertise of Compliance laws, rules, regulations, risks and typologies;
• Excellent written, verbal and analytical skills
• Must be a self-starter, flexible, innovative and adaptive;
• Highly motivated, strong attention to detail, team oriented, organized
• Strong presentation skills with the ability to articulate complex problems and solutions through concise and clear messaging
• Ability to work collaboratively with regional and global partners in other functional units; ability to navigate a complex organization; to influence and lead people across cultures at a senior level
• Experience in managing regulatory exams and relationships with examiners, auditors etc.
• Awareness of regulatory requirements including local and US laws, international and industry standards
• Advanced knowledge in area of focus preferred
• Experience in managing or leading staff preferred

Education:

• Bachelor’s degree; advanced legal degree preferred
• Experience in compliance, legal or other control-related function at a peer financial services firm, or at a regulatory organization or legal/consulting firm working with a peer financial services firm, or a combination thereof

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Citi is an equal opportunity and affirmative action employer.

Qualified applicants will receive consideration without regard to their race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

Citigroup Inc. and its subsidiaries ("Citi”) invite all qualified interested applicants to apply for career opportunities. If you are a person with a disability and need a reasonable accommodation to use our search tools and/or apply for a career opportunity review Accessibility at Citi.

View the "EEO is the Law" poster. View the EEO is the Law Supplement.

View the EEO Policy Statement.

View the Pay Transparency Posting