Principal IS Architect, Quality Systems

About CooperSurgical:

CooperSurgical is a leading fertility and womens healthcare company dedicated to putting time on the side of women babies and families at the healthcare moments that matter most in life. As a division of CooperCompanies were driven by a unified purpose to enable patients to experience lifes beautiful moments. Guided by our shared values dedicated innovative friendly partners and do the right thing our offerings support patients throughout their lifetimes from contraception to fertility and birth solutions to womens and family care and beyond. We currently offer over 600 clinically relevant medical devices to healthcare providers including testing and treatment options as well as an innovative suite of assisted reproductive technology and genomic testing solutions. Learn more at .

Job Summary:

The Principal Architect leads the design deployment and optimization of Quality system specifically eQMS platforms across global business units. The Principal Architect partners with executive stakeholders regulatory teams and IT leadership to ensure systems meet compliance standards support innovation and enable scalable growth. The role includes ownership of vendor strategy governance and global program execution. The Principal Architect provides strategic leadership and oversight for the global architecture implementation and continuous improvement of Quality systems with a primary focus on Electronic Quality Management Systems (eQMS). This role drives enterprise-wide transformation initiatives ensuring alignment with regulatory requirements operational excellence and long-term business strategy across Cooper Companies.

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 ISOCFR 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 ofcloud-based/on premise/SaaSElectronic 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 createbusiness presentations
  • Expert using data analytic tools proficient in SQL advanced excel (VLOOKUP Pivot tables Graphing functions)
  • Knowledge of Reporting tools (ex. Power BI) andhands-onexperienceusingdashboards reportsand dataimports andexports for businessuse
• 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 youll 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 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 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 $131704 - $188149. 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.