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Manager, Quality Systems

Company: QuVa Pharma
Location: Temple
Posted on: March 30, 2019

Job Description:

Position Summary Responsible for managing Quality System aspects of compounding pharmaceuticals for compliance within the facility. Operates the area as the supervisor over the Quality Systems staff, coordinating day to day functions. Essential Functions / Key Results Area s The Site Quality Systems Manager will report to the Director of Quality Systems. Manage, develop and lead 2-3 Quality System FTEs. Maintain compliance with FDA 503B and cGMP guidelines / state and federal laws. Responsible for all activities related to the Batch Record Issuance/ Quality Document Administration/CAPA/Deviation/Investigation/Change Management Systems. Manage the Self-Inspection and inspection readiness programs for site including coordination of Regulatory (FDA/BOP/DEA/DOH) Inspections, and customer audits. Manage investigation/deviation activities by working with other departments to determine the possible causes of the deviation. Aid in the analysis of each of the possible causes in order to determine the true root cause. Coordinate follow up on due dates and status reports and closure with appropriate documentation. Provide review of investigation reports and supportive documentation (including data) for accuracy and completeness, where needed. Proposes and executes process and procedural changes to improve QS process performance, robustness, and efficiency. Establishes standard and meaningful metrics that align to goals, mission, and objectives for applicable department/program. Develops and distributes metrics to support the business. Facilitates site Quality Review and Management Review Board meetings. Collaborates functionally and cross-functionally to meet Quality Systems objectives and initiatives. Interacts with site efforts to ensure consistency in policies and practices. Competencies Ability to multi-task and prioritize Strong decision-making ability Ability to lead a team and communicate effectively Successful time management skills in order to coordinate successful accomplishment of an approved action plan with timelines and milestone tasks Education / Qualifications / Certifications Bachelor's degree in Life Science or other related field. Experience Minimum 5 years prior experience in Quality Systems or related Quality field/ cGMP / FDA regulated industry. Minimum 2-5 years supervisory experience. Leadership experience highly preferred. Excellent technical writing and verbal/written communication skills. Well versed in the compliance & quality requirements of 503B pharmaceutical industry and cGMPs and have demonstrated strength in problem solving and resolution. Strong interpersonal skills, demonstrating the ability to interact with people holding positions in manufacturing, both operations and quality - including compounders, quality specialists, pharmacists, supervisors, area management, as well as functional areas such as Human Resources, IT, Customer Service, and Pharmacy Services. Physical Requirements: Work in office and production facility environment Ability to sit and to stand for long periods of time Able to lift up to 30lbs It is the policy of QuVa Pharma to afford equal opportunity for employment to all individuals regardless of race, color, age, national origin, physical or mental disability, history of disability, ancestry, citizenship status, political affiliation, religion, gender, transgender, gender identity, marital status, status as a parent, sexual orientation, veteran status, genetic information or other factors prohibited by law, and to prohibit harassment or retaliation based on any of these factors. Employment Type: Full Time Years Experience: 5 - 10 years Bonus/Commission: Yes

Keywords: QuVa Pharma, Temple , Manager, Quality Systems, Executive , Temple, Texas

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