Principal IS Architect, Quality Systems presso CVI

Key Responsibilities:

Strategic Leadership

• Collaborate with Internal teams (e.g., Quality, IT, business units) to ensure alignment and address their needs.
• Define and execute the global Quality Systems architecture roadmap.
• Champion innovation through AI/ML, predictive analytics, and digital transformation.
• Align systems strategy with corporate objectives and regulatory frameworks.

Governance & Oversight

• Chair global governance boards for lifecycle management of Quality Systems.
• Lead vendor selection, contract negotiation, and performance oversight.

Global Program Management

• Manage multi-million dollar budgets and global resource allocation.
• Lead enterprise-wide rollouts across geographies, ensuring localization and compliance.
• Manage project tasks, monitor progress, and ensure adherence to project timelines and deliverables.

Executive Engagement

• Present program status, risk mitigation, and ROI to senior leadership and regulatory bodies.
• Serve as executive liaison between IT, RA/QA, and business units.

Compliance & Validation

• Documentation of Business Requirements and Testing required for IT Change Control and Validation activities.
• Ensure systems meet ISO 13485, 21 CFR Part 820/11, EU MDR, and other global standards.
• Oversee validation, change control, and audit readiness.

Deployment & Change Management

• Develop and manage deployment plans, resource allocation, and timelines.
• Lead change management initiatives to drive adoption and minimize disruption.

Training & Documentation

• Oversee development of training programs and SOPs.
• Ensure documentation supports compliance and operational excellence.

Incident & Risk Management

• Lead root cause analysis and resolution of system issues.
• Manage escalations with vendors and service partners.

Continuous Improvement

• Identify and implement enhancements to system performance and user experience.

Travel: 

Travel up to 25% may be required.

Qualifications

Knowledge, Skills and Abilities:

• In depth knowledge and use of cloud-based/on premise/SaaS Electronic Quality Management System (eQMS) in the Medical Device or Pharmaceutical industry. 
• Able to simultaneously work on large scale projects as well as handle day-to-day operational requests.
  • Participate in multiple projects by completing and updating project documentation
  • Document process design changes by conducting business and systems process analysis and design at a complex level
  • Focusing on quality improvement and data management while ensuring data is reliable and valid
  • Document process improvements including re-engineering and/or integrating new systems and processes with existing ones
  • Communication with internal and external customers to ensure systems provided meet the long-term business strategies
• Demonstrated ability to learn new systems and applications quickly 
• Ability to lead requirements gathering meetings and gain feedback and input from all participants, and report on the outcome of meetings 
  • Provide project level analysis – producing required project analysis documentation (business requirements, scope matrix, use cases, sequence diagrams, future state proposals, UAT plan)
  • Collaborate closely with developers to implement the requirements, provide necessary guidance to testers during QA process
• Excellent written and verbal communication skills in English.
• Software proficiency including:
  • Ability to use standard Microsoft Office apps to document changes, create business presentations 
  • Expert using data analytic tools – proficient in SQL, advanced excel (VLOOKUP, Pivot tables, Graphing functions)
  • Knowledge of Reporting tools (ex. Power BI) and hands-on experience using dashboards, reports, and data imports and exports for business use 
• Able to understand business processes and document these processes using Visio or other flow-chart tools. 
• Strong project management, Successfully manage multiple tasks with competing priorities, at any given point, strong relationship building skills & communication skills.  

Experience:

• 15+ years in regulated industry systems leadership (Medical Device or Pharma).  
• Proven success in global GxP software implementations and enterprise transformation. 
• Experience with MasterControl, Windchill, Veeva, or TrackWise preferred. 
• Background in RA/QA or Operations is a plus.

Education:

• BA (or equivalent) in Engineering, Computer Science or Business Administration preferred
• PMP or equivalent certification a plus

As an employee of CooperSurgical, you'll receive an outstanding total compensation plan. As we believe your compensation goes beyond your paycheck, we offer a great compensation package, medical coverage, 401(k), parental leave, fertility benefits, paid time off for vacation, personal, sick and holidays, and multiple other perks and benefits. Please visit us at www.coopersurgical.com to learn more about CooperSurgical and the benefits of becoming a member of our team.

To all agencies: Please, no phone calls or emails to any employee of CooperSurgical about this opening. All resumes submitted by search firms/employment agencies to any employee at CooperSurgical via-email, the internet or in any form and/or method will be deemed the sole property of CooperSurgical, unless such search firms/employment agencies were engaged by CooperSurgical for this position and a valid agreement with CooperSurgical is in place. In the event a candidate who was submitted outside of the CooperSurgical agency engagement process is hired, no fee or payment of any kind will be paid.

We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender, gender identity or expression, or veteran status. We are proud to be an equal opportunity workplace.

For U.S. locations that require disclosure of compensation, the starting base pay for this role is between $131,704 - $188,149. The actual base pay includes many factors, and is subject to change and modification in the future.  This position may also be eligible for other types of compensation and benefits.