Senior Manager, Internal Audit Program

Johnson & Johnson•West Chester, PA

About The Position

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit. We are searching for the best talent for Senior Manager, Internal Audit Program to join ou DePuy Synthes Regulatory Compliance organization located in West Chester, PA; Jacksonville, FL; Palm Beach Gardens, FL; or Raynham, MA. Reporting directly to the Senior Director, Regulatory Compliance, the Senior Manager, Internal Audit Program will: 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. This responsibility also includes the integration of the artificial intelligence tool into the Audit module as well as collecting feedback and decisions on enhancements, updating validation documents, writing and approving test scripts, generating test data/records, change management 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. Lead DePuy Synthes team that consults on compliance issues within and across business units, formulating solutions for process gaps and facilitating improvements and industry best practices, implements simplification tools and process efficiencies for the IA program. Support strategic business initiatives and growth imperatives across DePuy Synthes as related to compliance and internal audits. Ensure smooth integration of new acquisitions into the MedTech internal audit program and EtQ Audit. Support site closures and record clean up activities in the EtQ Audit module. Participate in cross functional teams to improve DePuy Synthes quality management systems and collaborate on strategic projects within DePuy Synthes, providing compliance oversight and/or input. Audit/Inspection Readiness: Supports company efforts in the preparatory activities for external audits and regulatory inspections. Participate in audits as required and support teams and functions in activities following external audits and regulatory inspections, including reviewing and/or approving the responses to observations prior to submission to sponsors and regulatory agencies. Responsible for communicating business related issues or opportunities to next management level Responsible for following all Company guidelines related to Health, Safety and Environmental practices as applicable. Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures

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.
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

Nice To Haves

Initiative in innovative approaches to Quality and Regulatory solutions and applications in a fast-paced changing business environment is preferred.

Responsibilities

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. This responsibility also includes the integration of the artificial intelligence tool into the Audit module as well as collecting feedback and decisions on enhancements, updating validation documents, writing and approving test scripts, generating test data/records, change management
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.
Lead DePuy Synthes team that consults on compliance issues within and across business units, formulating solutions for process gaps and facilitating improvements and industry best practices, implements simplification tools and process efficiencies for the IA program.
Support strategic business initiatives and growth imperatives across DePuy Synthes as related to compliance and internal audits. Ensure smooth integration of new acquisitions into the MedTech internal audit program and EtQ Audit. Support site closures and record clean up activities in the EtQ Audit module.
Participate in cross functional teams to improve DePuy Synthes quality management systems and collaborate on strategic projects within DePuy Synthes, providing compliance oversight and/or input.
Audit/Inspection Readiness: Supports company efforts in the preparatory activities for external audits and regulatory inspections. Participate in audits as required and support teams and functions in activities following external audits and regulatory inspections, including reviewing and/or approving the responses to observations prior to submission to sponsors and regulatory agencies.
Responsible for communicating business related issues or opportunities to next management level
Responsible for following all Company guidelines related to Health, Safety and Environmental practices as applicable.
Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures