IT Manager, Reg Affairs, Labeling and Compliance Systems (536003)
Zimmer Biomet
 Warsaw, IN

Zimmer Biomet is a world leader in musculoskeletal health solutions. Our team members are part of a company with a heritage of leadership, a focus on shaping the future, and a mission dedicated to alleviating pain and improving the quality of life for people around the world.

Job Summary

The IT Regulatory and Labeling Systems Manager is responsible for managing the processes and systems to ensure the effective implementation of the IT Regulatory and Labeling Management Systems comply with the applicable quality systems standards and regulations. The incumbent will work closely with functional and business groups, senior leadership and technical teams. This role leads the task of writing requirements to formally document business needs, deliver IT solutions to support the business needs as well as manage the IT operations of the respective systems. The incumbent manages and directs a group of IT quality professionals dedicated to the implementation and support of the quality processes. Responsible for managing and maintaining an operating budget.

Principal Duties and Responsibilities

Execute requirements gathering, elicitation, and development to capture and document business needs

Work directly with and serve as the liaison between business users, technology teams, and support teams

Collaborate with developers and subject matter experts to establish the technical vision and analyze tradeoffs between usability and performance needs

Serve as the conduit between the business community and the software development team through which requirements flow

Interface with vendor partners and design optimal solutions to integrate with existing business systems

Hire, train, develop, and manage IT quality systems personnel to effectively support and continuously improve the Quality Management System.

Maintains departmental budget within prescribed limits.

Expected Areas of Competence

  • Ability to work within a team environment and build relationships outside of the department as well as outside the company.
  • Proven ability to direct, build, develop and manage a team of professionals.
  • Must be familiar with all aspects and elements of a regulatory and labeling system.
  • Must be familiar with all aspects and elements of IT operations systems management including problem management, change management, and operational control of IT QMS systems.
  • Ability to deal with difficult situations with tact, professionalism, and discretion
  • Demonstrated technical expertise and aggressiveness
  • Ability to work with minimum supervision and consider options to complete quality work
  • Excellent communication skills (both oral and written), and ability to work with employees at all levels of the organization.
  • Proficient in personal computer skills including electronic mail, project management, record keeping, and routine database activity, word processing, spreadsheet, graphics, etc.

Education/Experience Requirements

  • B.S. in engineering or an alternative Bachelor's degree in a related discipline plus a minimum 6+ years experience in quality compliance/quality systems.
  • Ideal candidate would have experience with QMS platforms such as Windchill, Prisym, Robar
  • Quality discipline certification preferred (e.g., CQA, CQE, CQM, ITIL, CSM, PMI).

Travel Requirements

  • Up to 20% including international

Additional Information

EOE/M/F/Vet/Disability

For the second year in a row, Computerworld has named Zimmer Biomet one of the 100 Best Places to Work in IT. Computerworld recognized the 100 top organizations that offer challenging work for their IT employees while providing great benefits and compensation.

At Zimmer Biomet, we believe in The Power of Us, which means that we are stronger together. We are committed to creating an environment where every team member feels included, respected, empowered, and celebrated.

[