WuXi AppTec

  • Associate Director, Quality Assurance

    Job Locations US-PA-Philadelphia
    Job ID
    2018-4010
  • Overview

    Direct department employees, resources and programs to ensure compliance with all regulatory requirements; specifically Good Manufacturing Practice (cGMP), Code of Federal Regulations (CFR), EU Guide to Good Manufacturing Practice, International Conference on Harmonization (ICH), Good Laboratory Practices (GLP), Good Tissue Practices (GTP) and relevant foreign regulatory guidelines for biopharmaceuticals. Team responsible for the quality review of pre-executed and executed test methods.  Collaborate with operational counterparts to ensure compliance and client satisfaction.  Identify, implement and drive quality improvement projects and policies to reflect industry best practices.  In addition, coordinate and oversee the day-to-day aspects of the QA staff, including training and development. 

    Responsibilities

    • Works with direct reports to plan and prioritize operations for staff based on current and future workload
    • Responsible for employee development/guidance and conducting performance reviews in a timely and objective manner
    • Keeps team current with changes to GXP, including FDA and EU and other regulatory bodies as well as guidance documents (ie: ICH, ISPE, etc.)
    • Audits raw data in accordance with Good Manufacturing Practices (cGMP), Good Laboratory Practices (GLP) and Code of Federal Regulations (CFR) guidelines
    • Focus on driving continuous quality improvements.  Initiates and revise SOPs and Policies as necessary.
    • Conduct documentation review and approval including but not limited to: Testing and Manufacturing Batch Records, Cleaning Record, Client Protocols, Training Records, Qualification/Validation Documents
    • Review, approve and perform investigations and provide guidance for CAPA related to non-compliance situations using creative problem-solving skills.
    • Supports and actively participates, as needed, in client and regulatory audits/inspections.
    • Lead and/or participate on cross-functional teams and projects representing quality in positive and compliant manner. Work and interact in a collaborative manner at all levels of the organization.
    • 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.
    • Maybe required to work Holidays and weekends
    • Accomplishes staff results by communicating updated organizational information, job expectations and supporting their work
    • Plans, monitors, and appraises direct reports including performance competencies, goals and job results
    • Coaches, counsels, and conducts disciplinary actions
    • Develops, coordinates, and follows organizational systems, policies, procedures, and follows labor and capacity  standards
    • Ability to work in a team environment and independently as required
    • Contributes to the overall operations and to the achievement of departmental goals
    • Perform job specific tasks in compliance with applicable Regulations, International Standards, and WuXi AppTec Policies and Standard Operating Procedures.
    • Thorough understanding of Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP)
    • Performs other duties as assigned

     

    Qualifications

    Experience / Education   

    • Bachelors Degree required and
    • 10+ years relevant technical experience and min 5 years Managing people
    • BS/BA in Science related field preferred; or combination of relevant Experience & Education

     

    Knowledge / Skills / Abilities:

    • Thorough working knowledge of Regulatory Compliance, Quality System Management and Quality Assurance principles and practices. Strong knowledge of 21 CFR 210 and 211, 21 CFR Part 11, EU Guide to Good Manufacturing Practice.
    • Experience in the development, streamlining, and optimization of Quality Systems
    • Ability to use judgment, clear problem-solving and decision-making skills.
    • Ability to work under limited supervision and to handle complex problems.Excellent organizational and interpersonal skills. Ability to communicate effectively with all levels of the organization.
    • Experience in 21 CFR 58, PTC guidelines and ISO 17205 requirements preferred
    • Proficient in Oral & Written communication skills
    • Proficient in Microsoft (Excel, Word, Outlook)
    • Travel is required 5-10% , Domestic/International, Daily / Overnight

    Equal Opportunity Employer Minorities/Women/Veterans/Disabled

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