QA Validation & Testing Lead

Department Quality & Compliance Position Summary The Quality Manager is responsible for managing the ACUTA Quality Management System (QMS).  In other words, he/she must manage all ACUTA company-wide, quality policies, procedures, processes, programs, and practices, to assure the company of continuous conformance with appropriate standards and regulations.  This a very critical role within the organization as the Quality Manager will be the "Go To" person for answers related to quality, covering product specifications, supplier requirements, testing, verification, audits, corrective actions, non-conformances, benchmarking and the voice of the customer.  Duties and Responsibilities Quality Standards - Ensure that processes needed for the Quality Management System (QMS) are established, implemented and maintained. Manage and control documents and records all throughout the company. Quality Project Management - responsible for managing corrective action, process improvement, and auditing projects. Business Process Documentation - must be able to understand, comply, and improve established company policies and procedures.  Developing standard work, policies, procedures, job aids, and business process communications are a part of the job. Document Control - knowledge of the Quality documentation process, Document Control practices, and managing documents, records, forms, and work instructions is vital to maintaining company's compliance program. Quality Communications - Explaining business process compliance to others.  Asking questions, collecting business process information, and working with others in a positive and collaborative manner.  Quality Auditing - performs quality audits.  Clearly understanding the compliance requirements, collecting objective evidence, and writing up auditreports ensure the quality management system is operating effectively. Problem Solving - solves problems, typically in situations where general standardization should exist, but may not be operating effectively. Team Player -  is involved in teams and meetings at every level of the organization.  Management reviews, material reviews, supplier reviews, corrective action reviews, process improvement teams, audits, customer visits and strategy discussions. Detailed Responsibilities Report to management on the performance of the QMS and any need for improvement. Ensure the promotion of awareness of customer requirements throughout the organization. Ensure that a document control procedure is adopted to approve, review and update all changes to critical documents within the scope of the QMS. Ensure that records are established and maintained to provide evidence that the QMS is being followed and that there is a system in place for the identification, storage, protection, retrieval, retention time and disposition of such records. Ensure that the performance of the QMS is reviewed at planned intervals to ensure its continuing suitability, adequacy and effectiveness. This review means assessing opportunities for improvement and the need for changes to the QMS. Ensure that Quality Objectives are set by top management for measuring the performance of the QMS and that these are regularly reviewed. Ensure that all new staff are inducted into the requirements of the QMS related to their own roles and responsibilities. Provide update training as necessary. Ensure that all suppliers used by the organization are selected, evaluated and reevaluated and that records of this assessment are maintained. Ensure that an internal audit program is adopted to verify that the QMS conforms to planned arrangements, QMS arrangements and is effectively implemented and maintained. Ensure that appropriate action is taken when this is not the case. Analyze data on the effectiveness of the QMS and evaluate where continual improvements of the QMS can be made. This shall include data generated as a result of monitoring and measurement and from other relevant sources. Coordinate continual improvements of the QMS, ensuring that evidence of corrective and preventive actions taken are recorded and reviewed. Responsible for implementing and managing the Quality review and oversight of software products developed by ACUTA. Implement & monitor quality improvements in products and services. Monitor performance measures that include those measurements critical to customer satisfaction and compliance. Responsible for attending and hosting customer audits and follow-up on the findings with a plan of remediation. Qualifications The Quality Manager is expected to have 8 or more years of overall quality management experience, with a good understanding of the pharmaceutical industry regulations. Some of the required technical skills and abilities include a working knowledge of: Strong analytic skills with practical knowledge of how to identify key performance quality metrics to set targets for maintaining a state of compliance while identifying areas for improvement. Understanding of the Life Sciences industry and the drug lifecycle process. Knowledge of various regulatory submissions and recognize the differences. Understands the needs, guidelines and complexities of electronic publishing. Extensive experienceauditing software vendors and hosting customer audits. Understanding and application of domestic and international regulatory requirements. Outstanding communication skills (interpersonal, verbal and written). Proven track record of industry success. Strong leadership and management skills. Excellent teamwork and collaboration skills. (R1051863)
Salary Range: NA
Minimum Qualification
8 - 10 years

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