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Sr Quality Director

Lawrence, KS

Posted: 03/04/2022 Industry: Quality Control Job Number: JN -012022-14049 Division: Life Sciences

Job Description

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Title: Senior Quality Director
Location: Lawrence, KS
Job Type: Direct Hire
Salary: Competitive Salary and Benefits offered
Industry: Pharma/Med Device


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
  • 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
  • Manage the batch review and release activities
  • 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
  • Assesses and advises senior management concerning acquisition targets
  • Interacts frequently with all levels of internal management as well as across functions and franchises
  • Develops budget for plant or programs/department and ensures adherence to the budget
  • Manages overall coaching, training, development, and succession plans for the team
Qualifications
  • Strong leadership skills and demonstrated success in managing a team. Capable to manage in matrix and ability to interact successfully with multi-functions globally
  • In depth knowledge of the regulatory environment for manufacture of medical devices and therapeutics
  • Success working with multifunctional, global teams
  • Strong analytical, problem solving, and decision-making skills
  • Excellent verbal and written communication skills
  • Excellent interpersonal/communication/influencing/negotiation skills required
  • Quality expertise on tech transfer
  • Extensive working knowledge of applicable quality and regulatory standards and regulations
  • Experience in risk management, validation, analytics, and microbiology, within a GMP environment
  • Comfortable and capable of gowning into an ISO 7/ISO 8 manufacturing environment
Education and Experience
  • BS in science or engineering; advanced degree helpful
  • 7 years management experience
  • Minimum of 10 years of experience in Quality, Manufacturing, or related field in the medical products industry
SRG offers flexible staffing solutions with a national presence. We provide contract, contract-to-hire, direct hire and executive search services. SRG utilizes an innovative approach to identify and qualify talent that is unique to the Staffing industry, featuring a cutting-edge platform that allows us to match professionals rapidly and precisely to client requirements. We have a proprietary database of over one million candidates and maintain continuous contact with our qualified talent.
EOE/ADA

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