Resume Of: Stephanie Y

Olivia Garrish [email protected] 200 Four Falls Corporate Center Suite 225 West Conshohocken, PA 19428 610-897-2391 Manager, Quality Risk Management Fort Washington/Lancaster, PA

Intuitive Technology Solutions is currently recruiting for a Manager, Quality Risk Management (QRM) located in Fort Washington, PA.

RESPONSIBILITES:  The role of the Manager, Quality Risk Management (QRM) is to lead and direct the implementation risk management processes, procedures, training and tools. The Manager, QRM will support the MCH sites and functions by identifying, mitigating and communicating compliance and quality risks through use of the prescribed tools ensuring that QRM is incorporated throughout the lifecycle of the products and processes.  The Manager, QRM is accountable for assisting in achieving CD work plan deliverables associated with the defined milestones at their respective site. Ensure completion of the Numbered and Lettered Steps in the Consent Decree work plan, as well as the closure of all gaps identified in the Quality System Elements (QSE) Roadmaps (derived from 483's, Quantic Baseline Inspection, deviations, Interim Controls, PVQIA, etc).  As a member of the Quality Assurance team, the incumbent will also contribute to strategic and operational tasks related to quality and compliance base business activities.  Be the site's liaison between the local QRM teams/QSE's and the Home Office Group for Risk management initiatives.  Lead the Quality Risk Management Process to conduct quality risk assessments for the facility, manufacturing process and products.  Participate in data driven risk assessments (risk identification, analysis and evaluation), formulate strategies for risk control and ensure periodic risk review.  Implement a risk assessments approach including the use of process mapping and preliminary risk assessments for determination of the Critical Quality Attributes and Critical Process Parameters.  Evaluate and communicate quality/compliance risk and identify mitigating strategies. Recommend, initialize and/or sponsor corrective actions and continuous improvement.  In coordination with the Site QRM Product/Process Owners and the Quality organization, work to develop and implement a sustainable framework of Quality Risk Management processes/procedures, tools, training and metrics to monitor the ongoing QRM program.  Develop risk management standards and best practices documentation required to support the QRM program. Review and ensure that operating procedures and standards are developed and implemented in accordance with FDA regulations, Industry guidance's and ICH documents related to risk management. Coach, mentor and train team members through project execution. Act as change agent for team and organization relative to the new way of working.  Participate in, and lead when appropriate, investigations related to department or network system non-conformances. Olivia Garrish [email protected] 200 Four Falls Corporate Center Suite 225 West Conshohocken, PA 19428 610-897-2391

REQUIRMENTS:  A minimum of a Bachelor's Degree in science, engineering or related discipline is required. A minimum of 5 years of Quality Assurance/Compliance experience in the pharmaceutical, biotech or medical device industry is required. Advanced degree and Six Sigma certification is highly desirable.  Experience working in an FDA regulated pharmaceutical plant environment is required. Demonstrated experience leading projects or managing functions associated with a variety of Quality Assurance activities is preferred.  Thorough working knowledge and hands-on experience with ICHQ9 and the implementation of quality risk assessment and process excellence programs is preferred. Demonstrated experience leading matrix teams is required.  Extensive understanding of ICH Q9 (Quality Risk Management), Regulatory requirements and industry guidances is required as is extensive GMP, GxP experience.  A thorough understanding of cGMPs for prescription or over the counter products and systems used in their deployment is required.  Excellent communication skills - written and verbal are required. Proven ability to deliver on complex, cross functional projects is required. Demonstrated systems thinking, strong analytical, technical, problem solving and organizational skills are required.  The ability to communicate with Subject Matter Experts (SMEs), QRM Decision Makers and other QRM Stakeholders is required. The ability to drive and conduct, if required, Risk assessments or to serve as a facilitator in the use of QRM tools is preferred.  Demonstrated competence in the application of QRM principles as they relate to Quality by Design (QbD) and current Pharmaceutical Risk based process validation requirements is preferred. Experience in authoring QRM plans and Quality Risk Communication reports is preferred.  Versed in basic enterprise computing platforms, architectures and technologies (SAP, MS Office) is preferred. This position will be based in Fort Washington, PA and will require up to 20% travel.  Assignment duration of the Quality Risk Management Manager, CD to last through December 2014.

About Intuitive Technology Solutions: Intuitive Technology Solutions is a comprehensive provider of staffing and workforce solutions throughout the Scientific Industry, including Biotechnology, Pharmaceutical, Clinical Research, Healthcare, Biodefense, Environmental, Chemical and Food Sciences. We are actively seeking candidates for contract, contract-to-hire and permanent placement jobs throughout the nation. View our website to see a list of our current open positions; however, not all of our positions are listed so don’t forget to submit your resume and request a consultation with one of our scientific recruiting specialists to explore your opportunities further. At Intuitive Technology Solutions we understand that next to your family, your career is one of the most important aspects to a happy and fulfilling life. This is why we take the time to truly understand and get Olivia Garrish [email protected] 200 Four Falls Corporate Center Suite 225 West Conshohocken, PA 19428 610-897-2391 to know our candidates, so we can then pair them with the right job, not just any job. As a result, Intuitive Technology Solutions is known throughout the industry for quality, reliability and the highest satisfaction from both our clients as well as the candidates that we represent. Intuitive Technology Solutions is an equal opportunity employer.