WuXi AppTec

  • Manager, Quality Management (Austin Based Only)

    Job Locations US-TX-Austin
    Job ID
  • Overview

    Job Summary: The Manger of Clinical Research Quality Management oversees quality functions for the company including, but not limited to development and maintenance of quality assurance programs and policies, oversight of inspections and audits, management of the Standard Operating Procedures (SOPs), and performing quality checks for deliverables as needed.  Build collaborative working relationships with cross functional peers. Preference for this to be an in office or WFH in Austin area. Minimal travel is required.


    Essential Job Functions:

    • Provides operational support for Quality Assurance
    • Develop, implement and maintain corporate quality assurance policy and program
    • Maintain Standard Operating Procedures (SOPs) including periodic review and coordination of the initiation/revision of procedures and policies to ensure compliance with new/revised regulations and guidelines
    • Monitors and directs updates of SOP/PD training records
    • Provide regulatory guidance and interpretation to internal customers and external clients
    • Serve as senior quality management representative
    • Keep senior management apprised of compliance risks
    • Serve as focal point for sponsor or regulatory audits as required
    • Utilize metrics and other tools to monitor compliance and ensure continuous improvement of clinical quality program
    • Provide direction and guidance to address compliance risks
    • Perform quality checks for deliverables as needed
    • Partner with cross functional groups to resolve compliance issues and oversee the implementation of corrective and preventive actions
    • High-quality deliverables implemented and maintained quality assurance program, compliance SOP system, and quality deliverables
    • Position requires employee to be aware of budget constraints for the company and ensure activities performed within the operations unit are within the constraints of the budget
    • Poor management of operational budget could result in poor company profitability
    • Gives direct supervision to independent quality assurance auditors engaged by the company to perform quality assurance functions
    • Receives direct supervision from President & CEO
    • Must show ability to problem solve with consideration given to quality, time, and financial resources
    • Is expected to apply decisions from previous discussions to new situations independently
    • Expected to require minimal supervision on operational decisions that can have substantial impact on infrastructure or company policies
    • Works on routine assignments per written procedures, where ability to recognize deviation from accepted practice is required
    • Normally receives minimal instructions on routine work and detailed instructions on new assignments
    • Works under supervision from supervisor or senior personnel
    • Ability to work in a team environment and independently as required
    • May be required to work Holidays and weekends
    • Contributes to the overall operations and to the achievement of departmental goals
    • Thorough understanding of FDA Guidelines, ICH, GCP, NDA, IND and other applicable regulations
    • Other duties as assigned
    • May be required to assist in other departments


    Job Requirements


    Experience / Education:         

    • Bachelor’s or Master’s degree are preferred
    • Associate’s degree or HS diploma with commensurate experience
    • Global Quality experience preferred
    • Must exhibit positive, professional demeanor in all communications and must be able to introduce differing communication strategies to solve issues at the team and sponsor level
    • Must exhibit excellent technical writing skills in English and must show ability to be an active listener
    • Must have experience in reviewing documents that may include, but is not limited to informed consents, data management plans, essential documents review, and clinical study reports



    Knowledge / Skills / Abilities: 

    • Required skills to speak with team and sites in English (Bilingual in Mandarin preferred)
    • Ability to effectively communicate issues and to autonomously implement resolutions to team members
    • Must show excellent interpersonal communication skills and exhibit ability to lead team using appropriate motivational skills, conflict management, and integrity
    • Clear presentation skills
    • Must have excellent organizational skills and negotiation skills; must have advanced knowledge of FDA guidelines, ICH Guidelines, and GCPs; must have project management skills including client management, fiscal management, and quality management; strong time management skills; and ability to thrive in stressful environment with multiple priorities
    • Demonstrated ability to provide leadership for key strategic issues and significant QA policies, practices and processes
    • Demonstrated experience in making decisions to resolve the most complex problems and in providing sound compliance advice and direction
    • Must have high level of attention to detail and must have ability to deal professionally with team members, clients and investigational sites
    • Must have knowledge of sponsor requirements for quality assurance functions within the CRO environment
    • Must have human resource management skills including ability hire, counsel, and terminate employees; must also be able to create career plans and to monitor progress
    • Must have ability to analyze resource usage with available tools
    • Minimal travel is required


    Physical Requirements:                  

    • Must be able to work in an office environment, which has minimal noise conditions
    • Ability to stand or sit for most of the work day
    • Must be able to perform some activities with repetitive motion, such as keyboarding


    This job description does not state or imply that the above are the only duties and responsibilities assigned to this position.  Employees holding this position will be required to perform any other job-related duties as requested by Management.


    An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.


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