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Kelly Services is currently seeking a Senior Quality Director for a Permanent position in Lawrence, KS .Job Description: The Senior Quality Director develops and deploys the quality system for a small to mid-size plant manufacturing Medical Devices and Biologics, while assuring systems and procedures for regulatory compliance are established and deployed. Will periodically review the suitability and effectiveness of the quality system with executive management as well as manage regulatory inspections.Essential Duties and Responsibilities Manage the batch review and release activities Directs large programs and departments in support of division or company-wide initiatives. Is responsible for results in terms of product quality and conformance to regulations and company policies Develops and deploys the quality systems (e.g., management review, CAPA, design control, process control) that ensure products conform to defined requirements Drives continuous improvement of processes and systems locally as well as deployment of such divisional and corporate initiatives with the objective of achieving quality, reliability, and cost improvements Assesses and advises senior management concerning acquisition targets Interacts frequently with all levels of internal management as well as across functions and franchises Manages interactions with customers and regulators concerning the quality of products, systems, and processes Responsible for adherence to specifications and procedures that have been established to ensure product quality in area of responsibility Develops budget for plant or programs/department and ensures adherence to the budget Manages overall coaching, training, development, and succession plans for the teamQualifications In depth knowledge of the regulatory environment for manufacture of medical devices and therapeutics Strong leadership skills and demonstrated success in managing a team. Capable to manage in matrix and ability to interact successfully with multi-functions globally Strong analytical, problem solving, and decision-making skills Excellent verbal and written communication skills Success working with multifunctional, global teams Excellent interpersonal/communication/influencing/negotiation skills required Extensive working knowledge of applicable quality and regulatory standards and regulations Experience in risk management, validation, analytics, and microbiology, within a GMP environment Quality expertise on tech transfer Comfortable and capable of gowning into an ISO 7/ISO 8 manufacturing environmentEducation and Experience BS in science or engineering; advanced degree helpful Minimum of 10 years of experience in Quality, Manufacturing, or related field in the medical products industry 7 years management experienceAPPLY NOW!For immediate consideration, please send your resume to gaut985@kellyservices.comWhy Kelly ® ?Kelly® Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interests—it’s the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.About Kelly ®At Kelly, we’re always thinking about what’s next and advising job seekers on new ways of working to reach their full potential. In fact, we’re a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)
