CAROL HUTTNER 908-***-**** (Mobile)

** ****** **** ** **********, NJ 08822 acvkhs@r.postjobfree.com

QUALITY AND COMPLIANCE PROFESSIONAL experienced in the pharmaceutical, medical device, and biotechnology areas with a proven track record of building systems, and maintaining quality programs to ensure quality products are developed, manufactured, packaged, and dispositioned on time. Highly effective in supporting supply chain networks and processes that meet both customer and company needs. Successful record interactions with FDA and other global regulatory agencies for Pre-Approval Inspections, and general inspections, as well as preparing regulatory responses. Excellent leadership, planning, problem solving, negotiation and multi-functional team leadership skills. Expertise includes:

●Consent Decree Management

●Cost of Quality Review

●Development of Metrics Program

●GMP/GLP/GCP, Quality Systems, ISO,MDD

●Risk Management Audit Program

●Supply Chain streamlining

●Policies and Procedure Gap Analysis

●Mentoring of Staff

PROFESSIONAL EXPERIENCE

The Medicines Company, Parsippany, NJ 2015-2016

DIRECTOR, GXP QUALITY SYSTEMS

Established robust Quality Systems (including audit program, complaints, change control, deviations and investigations, CAPAs, training, documentation, batch dispositioning, etc.) for products.

LifeCell, Branchburg, NJ 2013-2015

DIRECTOR, REGULATORY COMPLIANCE

Implemented and maintained a compliant Quality System after a Warning Letter. Identified the metrics to ensure compliance and evaluated issues pro-actively.

Initiated a Program to analyze all departmental SOPs and the associated Quality policies which ensured a robust system for compliance to support all internal and external audits and ensure quality

Managed Material Review Board (MRB)

Executed actions for significant quality events (recalls, field alerts, etc.)

Performed compliance review of existing aseptic processing and new sterile suites

Reviewed and approved validation documentation

Liaison for all agency and third party inspections

Teva Pharmaceuticals, Horsham, PA 2011-2012

SENIOR DIRECTOR, SUPPLY CHAIN QUALITY ASSURANCE

Led the Departmental Direction and Strategy which comprised of 40 plus employees, and a budget of $10M for our Third Party/Contract Service Suppliers and external manufacturing sites. Identified the scope for the department to maximize efficiencies, and ensure the quality of clinical and commercial products to conform to established company standards and agency regulations.

Performed a gap analysis program to develop a streamlined process for product launches which reduced cycle time, and met all launch dates with quality products

Reduced the time for lot dispositioning by 8% in one year by working closely with the senior management team and targeted supply chain partners to optimize outsourced manufacturing model

Implemented a system for the authoring, review, and managing of Quality Agreements

Approved Annual Product Reports to ensure compliance

Reviewed all CAPAs, investigations, deviations, change controls, and other non-conformances

Approved all scale-up technology transfer activities/validation programs at assigned sites

Novartis Corporation, East Hanover, NJ

2009-2011

DIRECTOR – GLOBAL COMPLIANCE AND AUDITING

Performed global audits of the organization to ensure consistent quality standards, and identify compliance risks in advance. Selected as a Co-Leader for the Global Quality Audit Communications Team which developed a tool to share Lessons Learned, Case Studies, and other information which improved the Compliance level for the global Quality Departments in the organization.

Developed a Training Program for Regulatory Inspections that was used throughout the organization which supported successful preparedness for Pre-Approval Inspections for new products, as well as Compliance Fraud Training

Reduced rejection rate for a product by identifying the root cause problem in a specific test for a medical device

Supported sites in the implementation of Quality Policies and Quality Standards

Monitored CAPA effectivity at an assigned site which reduced the product cost by about 10%

Managed audit execution for drug products, active pharmaceutical ingredients, medical devices, components, excipients, packagers, aseptic manufacturing, and service providers

Supported the database for Regulatory Compliance Intelligence

Abbott Laboratories (Kos Pharmaceuticals), Edison, NJ 2004-2009

DIRECTOR, QUALITY SYSTEMS

Developed and implemented Quality Systems to support KOS Pharmaceuticals for both clinical and commercial products after their receipt of a warning letter, which led to all subsequent regulatory inspections by the FDA, MHRA, etc. being successful.

Determined the KPIs, and improved Right the First Time Numbers year after year by a minimum of 10%

Developed a Training Plan for the sites, including the development of curriculum types, with the launching of IsoTrain which led to improved efficiencies in evaluating the training needs and statuses of employees performing GMP work

Launched TrackWise for the management and monitoring of all Key Quality Indicators such as Notice of Events, Deviations, CAPAs, Investigations, and Complaints which ensured the identification of quality issues and appropriate root cause analysis. TrackWise was launched on time, and was expanded to support both the R&D and commercial products.

Primary liaison for all regulatory agency inspections (FDA, EMA, ANVISA, GCC, TGA, etc.)

Directed and monitored the technology transfer program to Third Parties/Contract Service Providers

Developed the risk based audit program

Schering-Plough Corporation, Kenilworth, NJ 2000-2004

DIRECTOR, CORPORATE COMPLIANCE CONSENT DECREE TASKFORCE

Selected to participate as a member of the original Corporate Compliance Taskforce, as a result of the Consent Decree

Managed 6 project managers, and worked in a matrix organization to support the development and implementation of 92 Quality Standards at 15 FDA regulated sites

Received 3 Quality Awards for improving the Change Control System at the Puerto Rico site

Supported the revalidation program which ensured that all medical necessary products were available from the Puerto Rico site for the US market

Liaison for Regulatory Agency Inspections

ASSOCIATE DIRECTOR, STRATEGIC REGULATORY COMPLIANCE - at Schering-Plough Research Institute

Restructured and developed the R&D Quality organization into functional areas of documentation, training, validation, auditing, and strategic continuous improvement, which comprised a staff of over 20 plus employees, and a budget of $4M, for productivity efficiencies

Developed and implemented a risk based audit program to improve the workload efficiency by reducing the number of audits by 12% annually, and identifying and prioritizing audits which were most critical

Developed and approved all Quality SOPs in the Schering-Plough Research Institute which ensured consistency, and prevented gaps

Primary liaison for all regulatory inspections, and responses to the agencies

Reviewed all processes and systems to ensure appropriate quality oversight was in place for the stage of drug development

AVENTIS CORPORATION, Bridgewater, NJ 1998-2000

ASSISTANT DIRECTOR, CORPORATE REGULATORY COMPLIANCE

Selected as the Global Leader for Pre-Approval Inspections to provide support for which ensured the first successful inspection at the Frankfurt, Germany site

Performed 4 due diligence audits that led to successful acquisitions of new products

EDUCATION

Master of Business Administration (MBA), Chemical and Pharmaceuticals,

Fairleigh Dickinson University, Teaneck, NJ- Elected to National Honor Society

Bachelor of Arts, Biological Sciences, Rutgers University, New Brunswick, NJ- Graduated with High Honors

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