Mark Iampietro

Current

VP Quality, Regulatory & Clinical Operations at Spherics, Inc

Past

Director of Quality at Cynosure
Director of Quality at MedChem Products, Inc
QA Manager at Summit Technology

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Education

Worcester Polytechnic Institute

Recommended

3 people have recommended Mark

Connections

85 connections

Industry

Pharmaceuticals

Mark Iampietro’s Summary

I am a QA Engineer by training and currently hold a VP of Quality, Regulatory and Clinical Operations position for a small pharmaceutical firm. My executive leadership in pharmaceutical and medical device firms spans the past two decades. My quality engineering, systems development and CAPA implementation is facilitated by my comprehensive knowledge of quality metrics, program management and statistical applications. With broad experience in quality programs from the supplier chain through manufacturing and product release; I have built and or rejuvenated quality systems at five companies. Thanks to my proactive and consistent implementation of 6 sigma type programs and lean manufacturing principles, frugal use of company time and resources I have simultaneously delivered both production increases as well as morale improvement.

Mark Iampietro’s Specialties:

• Total Quality System implementation for Quality, Regulatory & Clinical compliance (ICH, FDA 21CFR 211 & 820 and ISO 9001/13485)
• Managing all phases of Quality function (prog. planning, QE/RE, GXP compliance, valid. & prod. release)
• Program management & coord. of phase 1 & 2 IND/CTD clinical studies and pre-clin tox
• Submission of drug IND’s/IMPD’s and device Tech. Dossiers for CE marking
• Implementation of pre-prod QA systems for design control
• Management Rep. and CE Mark Coord.

Mark Iampietro’s Experience

VP Quality, Regulatory & Clinical Operations

Spherics, Inc

(Privately Held; Pharmaceuticals industry)

June 2002 — Present (6 years 7 months)

Manage all phases of Quality function (quality program planning, quality engineering, GXP compliance, CAPA, validation, and product release), Regulatory Affairs and Pre- Clinical & Clinical program management.
Director of Quality

Cynosure

(Privately Held; 51-200 employees; Medical Devices industry)

April 1998 — May 2002 (4 years 2 months)

Managed all phases of the quality function: inspection & test, product release, quality program planning, quality & reliability engineering, GMP compliance, supplier quality, complaint handling and Regulatory planning.
Management Representative for ISO 13485 and CE Mark Coordinator.
Director of Quality

MedChem Products, Inc

(Public Company; 51-200 employees; Medical Devices industry)

1994 — 1998 (4 years)

Managed quality function, overseeing all quality activities across two sites (Woburn, MA and San Antonio, TX): inspection & test, product release, GMP compliance, quality program planning, validation, supplier quality, document control, complaint handling and Regulatory planning. Management Representative for ISO 13485 and CE Mark Coordinator
QA Manager

Summit Technology

(Public Company; 51-200 employees; Medical Devices industry)

1990 — 1994 (4 years)

Managed quality function, overseeing quality activities across two sites (Waltham, MA and Cork, Ireland): inspection & test, product release, development & implementation of quality programs, quality & reliability engineering, GMP compliance, validation, SQA, supplier quality and complaint handling.