Manager, IT Quality Control - CSV Engineering

in Remote Location

Manager, IT Quality Control - CSV Engineering Job

Job Description Job Attributes+

  • Job ID

    b17e7bdf-f103-434e-b0de-120b6edf6de9

  • Req #

    20087429

  • Job Location

    Remote Location

  • Job Category

    Information Technology

  • Job Type

    Regular

  • Schedule

    Full time

What CSV Engineering contributes to Cardinal Health

IT Quality Control - CSV Engineering is responsible for owning the Quality activities in software validation for the enterprise.

  • Participates in CSV Process Governance activities.
  • Provides software quality engineering principles guidance and related regulatory expertise to project teams and others, encompassing external regulations and internal policies and procedures. 
  • Provides planning, oversight with approval in the validation testing process.
  • Ensures software validation strategies are effective, efficient and demonstrate a defensible compliance position for Cardinal Health.
  • Documents and communicates the validation strategy and is manages all aspects of the SDLC approach for Computer System Validation projects (using V-Model, Iterative, Waterfall, etc.).
  • Facilitates and documents risk as it relates to new or existing technology, systems, and tools (e.g., intended use, functional risk).
  • Applies quality methods in support of validation activities (documentation practice, statistical sampling, review, inspection, testing, test management, root cause analysis, etc.).
  • Works closely with Business, Quality, and IT professionals to ensure software validation tasks, activities and deliverables are timely and complete.
  • Manages the use of tools in support of validation activities (i.e., ValGenesis).
  • Supports the ongoing validation status in the change control process
  • Defends the software validation status when interacting with regulatory, customer or Agency inspection and audit personnel.

    Qualifications

  • BA or BS in a related field of study with 8 years of experience or equivalent combination of education and experience. 
Preferred certifications include CSQE.Proficiency in ISPE® Good Automated Manufacturing Practice (GAMP) and experience working in an Agile or Iterative methodology.
Proficiency in software development/engineering, systems testing, systems auditing and systems implementation in a regulated environment are required.A Covid-19 vaccination is required in order to be employed in this position. This includes either:2 doses of the Moderna or Pfizer vaccine1 dose of the Johnson & Johnson vaccine

What is expected of you and others at this level

Provides thought leadership toward the application of regulatory requirements to modern technology, automation, and ways of working (Agile & DevSecOps).Solid management/leadership skills, with the ability to lead an international staff with differing educational and employment backgrounds. Demonstrates good written and oral communication skills.Ability to train/mentor associates. Proficiency in GxP/QSR regulations (21 CFR Parts 11, 211, 212, 820, Annex 11, ISO13485, etc.) and knowledgeable in their interpretation.Ability to successfully work in a multi-task and demanding environment. Ability to work well and effectively interact with software development and implementation teams, Internal and Corporate Auditors and regulatory representatives of various government agencies as applicable.Ability to read, analyze, and interpret complex technical documents and manuals.   Ability to develop and present information on technical and regulatory topics. Knowledge and skills in quality-related methods and techniques including auditing principles and techniques, quality terminology, quality management principles and their applications and quality management tools and their applications.Ability to effectively present information clearly and concisely to internal and external stakeholders.Ability to use PC's and associated software.Certification by ASQ in Software Quality Engineering (CSQE) – Most preferred.

The Colorado Department of Labor requires all employers to provide the following information for all positions that could be performed in the state of Colorado

Anticipated salary range: $94,900.00 - $135,500.00

Bonus eligible: Yes

Benefits: Health insurance, 401k Contributions, Paid Time Off, Vacation, STD/LTD

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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