Senior Manager, Internal Audit Program

Role Overview

• Establish, evaluate, and maintain the internal audit program and procedures for DePuy Synthes to ensure DePuy Synthes quality management systems are operating in compliance; align internal audit schedules with the requirements of external standards and regulations, as well as with the needs of the DePuy Synthes business; ensure adherence to the internal audit schedule
• Serve as EtQ Audit business process owner/module lead for decisions on enhancements and issues; explores optimization and technology solutions, gathers VOC, initiates system enhancements, review software development lifecycle documentation, write and approve test scripts, coordinate testing, change management, trouble shoot issues, manage day-to-day administrative functions in the system, maintain master data.
• Develop metrics, compile data, and analyze audit results to identify trends, and present to management
• Ensure timely identification and escalation of compliance gaps observed during internal audits and for continuous improving the efficiency and effectiveness of the DePuy Synthes internal audit program.
• Ensure qualified personnel execute to the audit schedule and will design, plan, and offer training to qualify new auditors and to enhance the capabilities of existing auditors.
• Lead the auditor training academy, developing others and enhancing capabilities, auditing skills, and empowering with knowledge to promote risk-based auditing approaches.
• Connect with SMEs to create continuous technical education (CTE) training materials and inputs CTE content and recordings into the learning management system; creates competency assessments
• Lead the DPS Compliance Community of Practice meetings, coordinate presenters and prepare content relevant to products, regulatory requirements, industry trends, and auditing techniques.
• Research emerging regulatory trends and changes in regulations and standards to incorporate into the DePuy Synthes business to ensure ongoing compliance to these requirements.
• Ensure new or changing standards/regulations are integrated into the DePuy Synthes internal audit program, as appropriate, taking into consideration auditor training needs.

Requirements

• A minimum of a Bachelor’s degree is required. Degrees in Business, Life Science, Physical Science or Engineering required or equivalent is preferred. Master’s Degree also preferred
• A minimum of 8 years of experience in a medical device and/or pharmaceutical industry is preferred with at least 5 years in a Compliance role
• Experience as an internal auditor is a requirement
• An ability to understand, interpret and apply national and international requirements pertaining to the design and manufacture of medical devices (e.g. QMSR, ISO 13485, EUMDR 745/2017) is required
• The ability to sort, index, categorize, order, manipulate, and organize this information is required
• Must be able to work on multiple projects with accelerated timelines
• Excellent organizational skills and attention to detail is required
• Strong influencing skills.
• Outstanding communication (written and verbal), negotiation and leadership skills.
• Ability to listen, learn, teach, and think strategically are traits that are required for success in this role.
• Initiative in innovative approaches to Quality and Regulatory solutions and applications in a fast-paced changing business environment is preferred
• Very strong partnering, influence and change management skills
• Ability to engage senior management in identifying critical needs and to ensure effective deployment across the sector.
• Demonstrated ability to work remotely and partner globally required
• Ability to lead, negotiate and influence others in a complex matrix organization required
• Ability to foster an effective multi-functional, cross region, cross company team environment required

Benefits

• Health insurance
• 401(k)
• Vacation – 120 hours per calendar year
• Sick time
• 40 hours per calendar year; for employees who reside in the State of Colorado – 48 hours per calendar year; for employees who reside in the State of Washington – 56 hours per calendar year
• Holiday pay, including Floating Holidays – 13 days per calendar year
• Work, Personal and Family Time
• up to 40 hours per calendar year
• Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
• Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
• Caregiver Leave – 80 hours in a 52-week rolling period
• Volunteer Leave – 32 hours per calendar year
• Military Spouse Time-Off – 80 hours per calendar year