Monica Burt

Built the PMO group that serviced the SVP of Global Operations and the SVP of Global Quality and Regulatory Compliance. Sat on the staff of the SVP of Operations and worked closely with the SVP of Global Quality and his leadership team.

➙Designed a strategic deployment tool, resource plan and governance process to manage the delivery of the Global Operations Strategic Plan.

➙ Initiated first formal Program Management Office with the company. Created a career ladder approach, training program, and a global PMO organization Structure.

➙Hired and on-boarded a team of program/project managers, project analysts and engineers.

➙Oversaw the Global Operations deliverables to satisfy new MDR requirements.

➙Served on the Executive IBP team as representative for Global Operations PMO.

✩ SELECTED ACCOMPLISHMENTS ✩

➙Directed Procurement Excellence Transformation program that created $20M in savings with $12M net EBITDA impact by year end 2020 on an addressable spend base of $105M.

➙Created and implemented a process to deliver a Global Operations Program Management Office and Global Operations, Quality and Regulatory Review Board process. Improved alignment, clear accountability and efficient project execution of 1.5K global employees.

Merged and streamlined Tornier and Wright Medical's Strategic Sourcing and Purchasing teams and processes post merger. Was asked by SVP of Operations to take on this role after successfully managing the merger of the Tornier and Wright Medical Quality and Regulatory Compliance teams.

➙Designed Strategic Supplier Management Infrastructure including a governance system, routine business reviews and standardized supplier scorecards.

➙Developed and led network of dedicated teams to micromanage supply planning and delivery of 4 distinct market segments while also leading a team to develop and install a Global MRP system.

➙Led HPMS project on Supply Planning - mapped strategy from signal to delivery.

➙Served on the Executive IBP team as the representative for Global Strategic Sourcing and Purchasing.

✩ SELECTED ACCOMPLISHMENTS ✩

➙Orchestrated partnership with Best Cost Country supplier and established manufacturing transfer team;resulted in quality improvements and reduced lead times from 32 weeks to 4 weeks while decreasing costs 40-60%.

➙Led Global Operations team to transfer 3D printing of custom disposable instruments for US market to the US from France.Decreased order to delivery lead time from 5 weeks to 5 days.

➙Managed direct spend of $135M; led employees to investigate and create a strategy to bring indirect spend of $80M under the Global Strategic Sourcing and Procurement team.

Recruited and hired by Wright Medical to take over the execution of a divestiture Quality Plan and to rebuild the Quality Systems and Regulatory Compliance organization when Wright divested the hip and knee business to MicroPort in January 2014. Less than a year after starting at Wright Medical, the Sr. Director of Quality resigned and I was officially given responsibility for Global Quality Systems, Operations, Engineering and Tissue Banking reporting directly to the Chief Operating Officer.

✩ SELECTED ACCOMPLISHMENTS ✩

➙Developed 3-year Quality Systems road map to support $1B organization including a resource plan and budget

➙Generated and executed installation of a Tissue Banking Quality System for global tissue distribution in 32 centers in US, Europe, Japan, and Australia. (The execution of this plan was started in 2014 and finished under my Global Quality title in 2016.)

➙Hosted a 21 CFR 820 full Quality Systems Medical Device audit 4 months post divestiture with only one major observation (CAPA).

➙Coordinated and finalized quality system integration of $3.3B merger and five acquisitions.

➙Built Quality and Regulatory department from 19 to 63 to support post-divestiture business needs. Collaborated with Human Resources to design portfolio of Quality and Regulatory Compliance job descriptions with specific skills, experience, and educational requirements. Created career ladder, development plan program and standards for employee interviews and semi-annual reviews.

➙Installed Tissue Banking Quality System in 24 domestic and 6 international distribution centers.

➙Audit leader for 36 audits from global regulatory authorities with a 94% zero observation rate over three years.

➙Registered in the Medical Device Single Audit Program (MDSAP) during the pilot phase. Wright was only the 5th company to host the audit and the first to complete it with zero observations. This protected >$30M annual revenue in Canada and Brazil and reduced our internal cost of Quality Systems by 800k in year one.

➙Hosted 28 - 21 CFR 1271 audits of newly installed Tissue Bank Quality System; resulted in only three FDA form 483’s (2013 – 2016). All three 483’s were received in the first 14 months of the newly installed system while we were still working out small issues with the system and still training our newly acquired distribution teams.The distribution network went without findings under my leadership though 2016.

➙Hosted a 21 CFR 820 full Quality Systems Medical Device audit 4 months post divestiture with only one major observation (CAPA).