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Group: JOBS 2.0: Job Search Career Networking Staffing. Post Resume -Get Paid by Employers at Resumark .com Subject: Robert Ciociola posted a job: "Are you a good fit for this job? Manager, Quality Risk Management -548 in Lancaster, PA Manager, Quality Risk Management -Lancaster, PA 548 Contract position-21 months Send resumes to: bciociola@covexllc.com Job Description Job Description/Major Responsibilities: The role of the Manager, Quality Risk Management (QRM) is to lead and direct the implementation risk management processes, procedures, training and tools at Company Consumer Healthcare (MCH) sites. 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. Education: A minimum of a Bachelor's Degree in science, engineering or related discipline is required. Experience/Technical Competencies: 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. Job Knowledge/Skillsets: 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 Lancaster, Pa. and will require up to 20% travel. Travel: There is roughly 20% travel associated with this role. Contract Lenght: Through December 2014 http://bull.hn/l/11JQU/6"

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