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Quality Systems Manager- LMS

Company: Infotree Service Inc
Location: Cambridge
Posted on: April 5, 2021

Job Description:

Company Description Infotree's approach to every employee and customer is based around making a positive impact. We focus on over-servicing, continuous improvement and a high-quality culture. We're passionate about making successful matches for our employees and customers across the globe. Infotree prides itself in our proven track record and innovative culture with 100% focus on the employees and customers. Job Description Please rush your resumes at [email protected] or feel free to reach me at 734-928-2464.Job Description:Quality Systems works with functional management and other quality colleagues to ensure that all GxP systems are in a state of compliance and inspection readiness. Quality Systems manages the business unit's electronic Learning and Documentation Management System (DMS/LMS), including administration, as well as training and document compliance for all GxP users. Management and administration of other Quality Systems is shared across Client Global Quality. The position provides support and coordination in the development, design, and implementation of global and cross-functional GxP systems, and associated processes and procedures. Provides direction for alignment of implementation and support strategies for quality processes and supporting technology, and ensures the integrity, consistency, and harmonization of these processes and systems across the business unit in alignment with global Client. With oversight from Quality Systems management and VBU Quality leadership, provides guidance and coordination necessary to direct quality system support activities for the business unit, including but not limited to:--- Coordinate and disseminate cross-functional and regional globalization of the systems and processes that support Client Quality Management System (QMS)--- Provide support for the implementation of QMS, to include global and local procedures, and associated training content and delivery ensuring target employees have adequate training assignments Accountabilities / Responsibilities: --- Support daily operations of VBU quality systems.--- Track overall compliance of training activities and expertise for GxP and guidance for Non-GxP audiences--- Act as primary contact and support for training and documentation related questions and issues--- Assist with the development and administer the training in support of regulated activities--- Provides support developing strategies to ensure best practices are incorporated into the development of documented procedures and specified required training (globally, cross-functionally and regionally)--- Provide advice and expertise to employees to ensure the development, management and implementation of controlled documented procedures and business critical policy and procedures with associated training--- Responsible for quality oversight of VBU GxP document lifecycle states in the DMS--- Responsible for management of VBU GxP training assessments and assignments to applicable personnel--- Coordinate quality events/processes (deviation, change control, etc) and support review board activities as applicable--- Support quality metric reporting and periodic assessment of the health of VBU quality systems--- Support the product complaint triage process to ensure compliance with procedures/processes--- Support process and technology initiatives for VBU and Client quality systems; participate in continuous improvement projects--- Administer training for quality systems, which may include VBU specific user training or training globally within Client--- Author and maintain procedures supporting quality systems maintaining compliance with regulations and Client policies--- Generate reports, monitor training compliance and perform tracking and trending of relevant training data. Identify and evaluate gaps and develop corrective actions to close gaps.--- Ensure new personnel have appropriate GxP training assignments and provide new hire training for applicable quality systems--- Contribute to create and communicate an employment culture and values which attract, retain, and develop the most effective people. Education, Experience, Knowledge And Skills: --- Bachelor's degree in a scientific discipline with 5 years of experience and 3 years working in Quality Compliance or Systems within the pharmaceutical or related industry, including 3 years in a GMP Quality Assurance role. Experience may be substituted for a degree.--- Experience in administration and/or management of GxP documentation, training and quality event/process systems--- Must have ability to utilize knowledge and interpersonal skills to provide direction and development cross-functionally and regionally, at all organization levels--- Well organized and detail-oriented; must be able to effectively prioritize work--- Eager to learn, interact cooperatively and effectively with others in a team environment--- Possess advanced word processing, data entry and data presentation computer skills--- Excellent communication skills, both oral and written--- Experience in Labware, Trackwise, Assurx, QUMAS, NetDimensions, SAP or related systems a plus--- Ability to influence and work effectively with various business partners in multiple regions and cultures--- Strong project management skills Licenses/Certifications:--- Six Sigma, preferred Physical Demands:--- Manual dexterity required to operate office equipment (i.e. computers, phones, etc.).--- Lifting and moving supplies and equipment (up to 25 pounds). Travel Requirements:--- Willingness to travel to various meetings or Client sites, including overnight trips (-10%). Some international travel may be required Additional Information All your information will be kept confidential according to EEO guidelines.

Keywords: Infotree Service Inc, Cambridge , Quality Systems Manager- LMS, Executive , Cambridge, Massachusetts

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