Mark Harper Email & Phone Number

Muskego, WI, US

Northbrook, Illinois, US

Northbrook, Illinois, US

Wilmington, Delaware, US

Wilmington, Delaware, US

• Directs the Quality Assurance and Regulatory Affairs processes as they relate to FDA regulations and ISO 13485 requirements, initiates and implements regulatory and quality improvement activities as appropriate, and.
• Serves as the quality management representative
• Educates and trains employees as to their impact in the Quality Management System
• Ensure regulatory compliance and oversee the management of QC inspection, customer complaint, CAPA and RMA processes
• Manage 30+ quality, regulatory personnel
• Supports concurrent engineering efforts by participating in design development projects representing regulatory, quality assurance, and the customer

• FDA Response and Remediation:Analyze observations, lead internal investigations to assess all affected processes, identify root causes of noncompliance, draft a comprehensive Corrective and Preventative Action (CAPA).
• Prepare and provide oversight for submission dossier creation with respect to new products, renewals, product changes, advertising, and other licensing.
• Interpret country regulations and provide regulatory insight plus guidance to support organizational objectives, to reduce risk and to drive regulatory compliance.
• Develop and implement streamlined consistent processes for both new products and life cycle management.
• Provides regulatory leadership to develop and sustain productive relationships with in-country business partners.
• Monitor the external regulatory environmental changes and engage in shaping activities through industry association.

Chicago, US

• As a member of GE Healthcare’s (GEHC’s) Global Quality Compliance (GQC) audit staff, I work with a global team to deliver GEHC’s Quality, Regulatory, Medical (QRM) audit program for Pharma, Medical Device, Clinical.
• Conduct reviews, perform audits and document findings for complex and unusual businesses
• Provide follow up activities to ensure compliance with regulations and conformance with written and approved procedures
• Provide direction on root cause, proactively assess risk, plan and execute audit deliverable's
• Communicate audit results and recommendations
• Provide leadership in driving improvement efforts

Chicago, US

• Responsible for the Global General Electric Healthcare Quality Management System (QMS) including Training, Translations, Document Control, Quality Data Review and Analytics across a combination of 80+ global GE.
• Manage Global QMS change control, periodic reviews and deployment for QMS procedures, work instructions and training including master document source management.
• Responsibilities include but not limited to the following: Initiating and communicating document change control requests to executive leadership via DCAB management; Cross functional and multi-modality global document.
• Mnthly status: Global QMS deployment plan QMS document – Works in Progress; Risks to implementation; QMS wins and Actions; QMS change management metrics – Document throughput – English & translations; material Shipped.
• Maintain QMS history of life cycle change based on requirements flow down from applicable business standards, regulations, and directives.
• Conducts analysis of global metric data to provide comparison of prior periods, share insight/recommendations to strategic initiatives for imprvmnt.

Chicago, US

* Directing the site Quality Management System and 10 Direct reports, fully integrated with the GE Global QMS, including cross-functional and site specific processes, Management Representative for Quality at the site* Responsible for facility compliance covering voluntary, regulatory and company quality requirements and champion quality initiatives at all.

Chicago, US

QMS Leadership role driving high quality expectations in a global environment, while accomplishing improvements to Quality Systems in Americas, Europe and Asia.Accomplished global FDA inspection leader and Subject Matter Expert.Unifying a World Class QMS with best practices.Proven history of global auditing QMS, special process and medical device.

US

· Directed and Coordinated the Quality activities of Drug Coated Stent program to ensure compliance to Company QMS & FDA Regulatory Requirements were accomplished.· Responsible Medical Management representative for company related FDA compliance program. · Responsibility for Planning, Directing and Coordinating Quality activities as required for designated.

US

· Plan; direct and coordinate the business activities of Drug Coated Stent program to ensure goals and objectives are accomplished within prescribed time frame & funding parameters.· Review status reports prepared by program personnel and modified schedules or plans as required.· Establish Work plan and staffing for each phase of the program and arranged.

Newfield, New York, US

· Responsible management representative for company related FDA compliance program, 21 CFR parts 210 & 211.· Responsible for providing primary leadership in designing, leading, and directing all functions and aspects of the Quality Assurance Program.· Interpretation of quality philosophy to all personnel through training and Quality support.· Founded.

Newfield, New York, US

· Responsible party for company related FDA compliance program· Project manager and lead auditor, direct supervision of seven 7 fulltime and 5 seasonal employees.· Managed procurement, validation, manufacturing, maintenance, and quality activities.· Designed Quality system upon 21 CFR, parts 210, 211 and ICH.· Development and execution of IOQ, process, and.

· Management responsibilities included but not limited to; responsibility for lab staff of 3, lab GC and other analytical equipment, yearly budget preparation, daily assignments and functions.· Provided QC support for manufacturing and the R&D lab.· Project lead for Pilot scale research and development projects for customers such as E.I. DuPont, PPG.

Mis, Management Information Systems

Business Administration