Strategic International Quality Executive with over 20 years of proven leadership experience and a track record of achieving outstanding results within large multi-national corporations. Effectively driven progressive yet business oriented quality programs through the development and retention of high caliber teams. A common sense, data driven approach coupled with an extraordinary ability to assess and achieve global
Strategic International Quality Executive with over 20 years of proven leadership experience and a track record of achieving outstanding results within large multi-national corporations. Effectively driven progressive yet business oriented quality programs through the development and retention of high caliber teams. A common sense, data driven approach coupled with an extraordinary ability to assess and achieve global performance by creating metrics and measures that drive the right behaviors resulting in strong quality culture at all levels of the organization.
• Organizational Strategy and Vision
• Business Acuity
• International Experience
• Building and Developing High Performance Teams
• Relationship Building (Internal and External)
• Regulatory Intelligence
• Practical Application of Regulation
• Change Agent/Enabler
• Balanced Risk Management
Medical Devices, Pharmaceuticals, and Biologics
Vice President II, Corporate Quality @ Responsibilities and Key Accomplishments:
Scope/Direct reports – VP Quality Systems, VP Global Compliance, VP Global Field Surveillance and Supplier Quality, VP Design Assurance, Risk Management, and Business Excellence, Interim VP QA EMEA. Member of Baxter Global Leadership Team.
Architect of the Corporate Quality System, establishing policies and compliance strategies for 87 Baxter entities worldwide employing over 47,000.
Led the consent decree remediation and consolidation of the Baxter Quality System to a single centralized corporate quality system across 87 entities around the world.
Created Strategies and Structure for Global Product Life Cycle Management. Included creation of Design Assurance and Risk Management organizations. Worked with global R&D to implement Product Design Ownership & legacy remediation.
Global and Corporate Quality Metrics and Performance Measures to identify and mitigate risk.
Budgetary responsibility for >$60M. Increased productivity and reduced cost >6M in one year.
Led global simplification and consolidation efforts for key Quality Systems, reducing complexity and increasing efficiency. Including introduction of global Quality IT software solutions. From March 2009 to December 2010 (1 year 10 months) Vice President, Quality EMEA (Europe, Middle East, & Africa) @ Responsibilities and Key Accomplishments:
Direct Quality responsibility for 17 Manufacturing Facilities, 21 Distribution and Service Centers, and 5 Compounding Pharmacies in EMEA (Europe, Middle East, and Africa). Approximately 550 Quality Professionals. Budgetary responsibility >$50M.
Reporting to the Corporate VP of Global Quality and EMEA President. Member of Baxter Global Quality Leadership Team, European Senior Management Team, and leadership of European Quality Leadership Team. Selected as Baxter Top Talent.
Scope/Direct reports – VP EMEA Quality Shared Services, 4 Multi-plant Quality Directors, Director EMEA Quality Systems, Director EMEA Post Market Surveillance, Director EMEA Design Assurance, and EMEA Medical Director.
Created high-level and subsystem strategies for Region Europe quality that has driven performance from one of the lowest performing to one of the highest performing regional quality organizations. Eliminated European Quality System inefficiencies.
Completely restructured the Quality Europe to align with the business needs and created strategic quality planning process.
Created Site Performance and Metrics to drive the right behaviors.
Created “Reducing the Risk” programs that delivered Field Corrective Action reduction each year. From June 2006 to August 2010 (4 years 3 months) Corporate Director, Quality Systems & Compliance @ Responsibilities and Key Accomplishments
Scope/Direct reports – Director Corporate Documentation, Director Corporate Quality Systems, and Director Clinical Quality Assurance, Director Corporate Compliance, Post Market Compliance, and Quality Program Managers.
Led Corporate Quality Systems and establishment of Policies and Compliance strategies for currently 27 manufacturing and tier 1 distribution centers employing over 19,000 with 1,400 Quality Professionals.
Led remediation of FDA Corporate Warning letter and 483 remediation activities across the corporation. Responsible for response coordination and compliance strategies. Created successful strategies for corporate risk mitigation avoiding consent decree.
Designed, developed, & structured Corporate Quality departments into a stronger, well respected group that added significant value to the corporation.
Corporate Quality Metrics and Performance Measures. Chairman of the Compliance Council. Corporate oversight and approval of all compliance activities with the regulatory bodies. Provide training to sites on audit preparedness.
Legal affairs investigations and due diligence activities.
Completely restructured the Quality System for the entire corporation in compliance to the new 13485:2003 standard.
Created Site Performance and Corporate Metrics that are clearly and concisely identify to the corporation the areas needed for improvement.
Awarded The BSC Top Talent Award in 2005 (Top 1% of the Corporation), performance rating was Outstanding for 2005 (Highest that can be achieved). From July 2004 to June 2006 (2 years) Director of Quality, Cork Ireland Plant @ Plant head of Quality reporting to the VP of Quality Cardiovascular (Corporate) with the following overall responsibilities:
Site Quality System Management Representative for a 1000 person manufacturing site with 85 person Quality organization.
Selected to the Quality Steering Committee as representative for the 6 European manufacturing and distribution sites.
Products managed – Combination Products, Drug Eluting Stents, Neurovascular coils, Cardiovascular Catheters, Embolic Devices, Artharectomy devices, & Balloon Dilatation Devices. From June 2001 to July 2004 (3 years 2 months) Corporate Manager, Quality & Regulatory Affairs @ Formerly a Johnson & Johnson Subsidiary
Senior most QA / RA Management position in the company reporting to the President with the following overall responsibilities:
Corporate QA & RA responsibility for 3 manufacturing plants - Buffalo NY, Tijuana Mexico, & Castlerea Ireland. Assisted startup of Ireland facility.
Corporate quality system with compliance to medical device (PMA & Design Dossier Devices) quality regulations including ISO9001, EN46001, ISO13485, European Medical Device Directives, and FDA QSR.
Legal Affairs for product liability, class action suits, and operational agreements. From April 1995 to June 2001 (6 years 3 months) Quality Manager @ Senior-most QA Management position reporting to the President with responsibility to guide overall quality program at the Newbrook facility. Compliance to quality regulations include ISO9001, MIL-I-45208, ISR-1E, & MIL-STD-767. Manage relationship with resident in-plant government officials. Security clearance was required. From October 1989 to April 1995 (5 years 7 months) Staff Sergeant @ Quality Assurance and Aircraft Inspection
Active Duty & Active Reserves From December 1984 to August 1992 (7 years 9 months)
Bachelor's Degree, Industrial Technology Management, Biomedical Engineering @ State University of New York College at Buffalo From 1994 to 2000 Michael Murphy is skilled in: Quality Assurance, Quality System, CAPA, FDA, ISO 13485, Start-ups, Cross-functional Team Leadership, Pharmaceutical Industry, Medical Devices, Regulatory Affairs, Six Sigma, V&V, GMP, Quality Management, Business Strategy
Looking for a different
Get an email address for anyone on LinkedIn with the ContactOut Chrome extension