Brian Duncan Email and Phone Number
Chief Operating Officer at Quality Executive Partners, Inc. (QxP) at
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Quality Executive Partners, Inc. (QxP)
Brian Duncan's Location
Greater Houston, United States, United States
Brian Duncan's Contact Details
Brian Duncan work email
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Brian Duncan personal email
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Brian Duncan phone numbers
About Brian Duncan
Proven leader experienced in global quality and operations risk identification and risk monitoring, regulatory response and strategic communications planning, site-wide/ multi-site remediation planning and execution, site inspection planning and readiness execution, translating global network standards into local quality systems from the ground up, and driving transformative culture change. Extensive expertise in site regulatory remediation, regulatory approval of international sites, product technology transfer/launch and project management including current regulatory expectations for process qualification and lifecycle management.
Brian Duncan's Current Company Details
Quality Executive Partners, Inc. (Qxp)
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Chief Operating Officer at Quality Executive Partners, Inc. (QxP)
Brian Duncan Work Experience Details
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Chief Operating OfficerQuality Executive Partners, Inc. (Qxp) Jan 2020 - PresentAtlanta, Ga, UsQxP is a management consulting and technology firm, providing the life sciences industry with tomorrow’s innovative solutions, tailored to meet the most daunting technical challenges of today. We are scientific thought leaders, with decades of experience as executive leaders within global pharmaceutical firms and as trusted consulting partners to these firms. The mission of QxP is to ensure our clients meet their business, quality, and compliance goals simultaneously. We achieve this through a unique partnering relationship that provides technical expertise, educational tools, mentoring and execution support. Our success is defined by providing timely delivery of those goals coupled with the transfer of knowledge and capability to the client’s team.
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Sr. Vice President, Sales And Deployments- VirtuosiQuality Executive Partners, Inc. (Qxp) Jan 2018 - Jan 2020Atlanta, Ga, UsResponsible for global sales and implementation of Virtuosi, the first of its kind innovation in pharmaceutical sterile manufacturing education technology. Combining decades of preeminent technical knowledge focusing on the "why" of aseptic manufacturing, sterilization and microbiology principles with unique experiential learning, fully immersive virtual reality to embed learning on the matters that count. Elevate training by educating.
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Sr. Vice President, Global Engagement OperationsQuality Executive Partners, Inc. (Qxp) Jan 2016 - Jan 2020Atlanta, Ga, Us
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Strategic Practice LeadQuality Executive Partners, Inc. (Qxp) Jun 2014 - Dec 2015Atlanta, Ga, UsAt Quality Executive Partners (QxP), our mission is to bring bold revolution to quality consulting. We are fueled by the passion for doing what is right and being the much needed disruptive innovation! There may be nothing revolutionary about passion, but we turn that passion into real value, built on integrity and long-term client partnerships. And, in our industry, that is revolutionary. The QxP team is comprised of executives with extensive track records delivering successful outcomes in situations of intense regulatory scrutiny. Our executives have substantial experience interacting and negotiating with FDA and other global regulatory agencies. We take a pragmatic, strategic view of internal processes, quality system development, and implementation of key matters. Our approach is to “do and teach.” We assist our clients in developing Quality and Compliance organizations and leaders, all while getting real work done.
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President, OwnerTalon Quality Consulting, Llc Sep 2012 - Jun 2014Talon Quality Consulting, LLC partners with pharmaceutical manufacturing organizations to frame structured quality remediation programs, through proven implementation strategies and operating models. Utilizing established governance, tracking and reporting tools accelerates the minimization of risk and provides a foundation for long term sustainability. Specialties include remediation program architecture, compliance gap assessment, project deployment oversight and tracking for firms under regulatory stress. Additional expertise includes: product assessment for regulatory file compliance, quality systems review, for cause auditing and improvements in general laboratory practices.
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Senior Director, Site RemediationSandoz Apr 2012 - Sep 2012Basel, Basel-Stadt, ChResponsible for establishing program structure and day-to-day execution of $50+ million site-wide remediation program delivering improvements spanning re-capitalization and automation projects, site validation program improvements, statistical process control, quality systems remediation and operational right-the-first time gains on the manufacturing floor. -
Senior Director, Quality ManagementSandoz Aug 2010 - Apr 2012Basel, Basel-Stadt, Ch•Senior quality leader at solid oral dosage manufacturing site of approximately 500 employees. •Ensure local quality systems are established in compliance with company standards, local regulations, and applicable country regulations where product is marketed.•Design and implement the site quality management system through elaboration of the site quality plan based on Sandoz divisional strategic directives, risk assessment/risk management and ongoing internal assessments.•Drive best-in-class quality culture through implementation of site-wide proactive quality programs focused on employee engagement, establishing accountability levels, capability mapping and positive reinforcement for proactive quality behaviors.
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Director, ComplianceSandoz Oct 2009 - Aug 2010Basel, Basel-Stadt, Ch•Developed quality systems to ensure sustainable, compliant processes are in place throughout all areas of Wilson site operations, assuring the delivery of business results in all value streams.•Defined the role, operating principles and staffing of the Wilson compliance team to re-vitalize the internal auditing function, providing cross-functional training and certification programs to support system execution. •Designed and sponsored overall site behavior based quality improvement program designed to track pro-active, leading quality indicators and engage employees in early indication of system deficiencies, limiting downstream impact to production processes and deviation initiation.
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Manager, Compliance ProgramsSandoz Jul 2008 - Oct 2009Basel, Basel-Stadt, ChResponsible for a site-wide quality and compliance upgrade program at the Sandoz, Wilson NC manufacturing facility. The program includes various system level projects and development activities across all site operations and development areas.
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Manager, Transfer ProjectsNovartis Biociencias S.A. Jan 2007 - Jul 2008Basel, Baselstadt, ChOn international assignment in Sao Paulo, Brazil. Managed international technology transfer for pharmaceutical manufacturing processes between US and Brazil in support of major site expansion project. Managed regional transfers within Latin American and the Caribbean regions, and coordinated outgoing transfers into European sites. Lead matrix teams and developed business strategy related to proposed transfer activities. -
Manager, Qc Product TestingSandoz Us Dec 2002 - Jan 2007Basel, Basel-Stadt, Ch•Lead staff of 65 analysts, supervisors, and managers within the quality control testing operation at a major pharmaceutical manufacturing site (over 7 billion units, annual volume). •Delivered operational savings of over $2 million, 20% under budget.•Developed and implemented a laboratory sponsored community partnership program.•Administered department re-organization and consolidation, oversaw budgeting process, recruitment and hiring, staff development and succession planning. •Served as a steering committee member for various IT implementation projects for laboratory systems.
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Supervisor, QcCardinal Health- Sterile Technologies 1999 - 2002Dublin, Oh, Us•Supervised staff of 8 chemists across three shifts, encompassing all manufacturing support, quality testing functions at a small contract manufacturer of sterile pharmaceuticals.•Developed and implemented a new analytical technology transfer function.•Expanded responsibilities from stability testing only, to eventually include leadership of all manufacturing support laboratory functions as critical gaps were identified.
Brian Duncan Skills
Technology Transfer
Gxp
21 Cfr Part 11
Capa
Change Control
Regulatory Affairs
Gmp
Fda
V&v
Sop
Lims
Pharmaceutical Industry
Validation
Quality Assurance
Quality Management
Quality System
Biotechnology
Quality Control
Hplc
Analytical Chemistry
Biopharmaceuticals
Drug Development
Pharmaceutics
Quality Auditing
Regulatory Requirements
Regulatory Submissions
Computer System Validation
Cleaning Validation
Chromatography
Glp
Lifesciences
Brian Duncan Education Details
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The University Of Texas At San AntonioChemistry -
United States Air Force Academy
Frequently Asked Questions about Brian Duncan
What company does Brian Duncan work for?
Brian Duncan works for Quality Executive Partners, Inc. (Qxp)
What is Brian Duncan's role at the current company?
Brian Duncan's current role is Chief Operating Officer at Quality Executive Partners, Inc. (QxP).
What is Brian Duncan's email address?
Brian Duncan's email address is br****@****doz.com
What is Brian Duncan's direct phone number?
Brian Duncan's direct phone number is +191943*****
What schools did Brian Duncan attend?
Brian Duncan attended The University Of Texas At San Antonio, United States Air Force Academy.
What skills is Brian Duncan known for?
Brian Duncan has skills like Technology Transfer, Gxp, 21 Cfr Part 11, Capa, Change Control, Regulatory Affairs, Gmp, Fda, V&v, Sop, Lims, Pharmaceutical Industry.
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