A global medical device company and a leader in new product development and medical education in orthopedics is actively seeking a Manager, Global Change Control which works directly with the Global Quality to assure GxP changes at all company locations globally are in compliance with both QMS requirements and all applicable regulations. This opportunity is for a leader and a culture driver for the Company’s Regulated Change Management globally that requires implementations of concepts and systems through the entirety of the global organization. Excellent communications and analytical skills, strong technical project management skills and a Bachelors’ degree in Engineering, or related scientific field will be essential for this position. Join our talented team at a global medical device company focused on Helping Surgeons Treat Their Patients Better™.
Essential Duties and Responsibilities:
Ownership for, and continuous improvement of the Change Control processes with potential GxP impact.
Lead and drive a culture for Regulated Change Management globally.
Implement Change Control concepts and systems through the entirety of the global organization.
Acts as Subject Matter Expert on behalf of Quality Assurance in the assessment, risk mitigation development, and approval stages of Change Control processes.
Oversees the effective implementation of GxP changes and related processes into all applicable sites.
Determines and sets processes and documented procedures regarding the control of GxP changes for the company in compliance with FDA QSR, ISO 13485, and other applicable international regulatory requirements.
Implements, oversees, and maintains GxP Systems supporting Change Control functions across all applicable QMS locations.
Implements, measures, and reports key process indicators related to Global Change Control.
Performs effectiveness review activities to ensure Global Change Control processes are in compliance with all applicable requirements.
Develops advanced concepts, techniques, and standards for Change Control.
Serves as prime Change Control expert and external spokesperson for the organization on highly significant matters relating to policies, programs, capabilities, and long-range goals and objectives.
Trains Subject Matter Experts (SME) on change management best practices and risk management activities.
Collaborates with various stakeholders, assuring an effective implementation of change across the organization.
Communicates effectively with internal and external business partners to achieve company objectives; professionally communicates critical time-sensitive information exceptions and changes to affected parties.
Partners with Organizational Change Management to supplement the messaging behind high-visibility changes.
Drives continuous improvement of the Change Control systems and processes.
Ensures a high state of control for all QMS documentation throughout the entire organization.
Performs performance reviews, sets goals and objectives, and provides coaching for subordinates.
Supports Regulatory audits and inspections.
The above statements describe the general nature and level of work being performed in this job. They are not intended to be an exhaustive list of all duties, and indeed additional responsibilities may be assigned, as required, by leadership.
Education and Experience:
Bachelor’s degree in Engineering, or related scientific field required.
7 years’ experience within a Change Control function
2 years of people leadership experience required.
Knowledge and Skill Requirements/Specialized Courses and/or Training:
Knowledge and clear understanding of FDA QSR, ISO 13485, and all other applicable international regulations in the areas of Quality System Requirements and Change Control. Excellent proven interpersonal skills.
Machine, Tools, and/or Equipment Skills:
Desired proficiency in the use of PC and programs, particularly Microsoft Office, SAP, and Documentum.
All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.