WuXi AppTec

Director Quality Assurance

US-PA-Philadelphia
Job ID
2017-3340

Overview

Provides complete oversight for all quality/compliance operations at the Philadelphia site.  Monitor and maintains quality systems to keep current with regard to the practice of all appropriate Good Manufacturing Practice (cGMP), Good Tissue Practice (cGTP), Good Laboratory Practice (GLP), Code of Federal Regulations (CFR), Points to Consider (PTC), International Conference on Harmonisation (ICH) and relevant foreign regulatory guidelines for biopharmaceuticals and Cell Therapy products.  Build a team of capable resources working in a collaborative environment

Responsibilities

  • Drive continuous improvement and execute pro-active quality control in site’s processes.
  • Maintain responsibility and support for ensuring that problem investigations are completed in a timely fashion in order to meet customer commitments and defendable to regulatory bodies. Ensure appropriate CAPA’s are assigned and carried out to ensure compliance and to achieve improvement.
  • Direct and Manage QA support for site quality systems such as Investigations, Corrective and Preventive Actions, and Product Quality Complaints.
  • Lead and participate in site quality and process improvement initiatives, and project teams. Provide compliance support, expertise and training for the site. Provide direct and immediate support for internal, external and regulatory audits of site.
  • Oversee compliance-critical functions including change control, validation and compliance and quality improvement projects.
  • Develop, implement and approve QA policies and procedures.
  • Effectively communicate and flow down objectives to all employees.
  • Establish and maintain a closed loop management process that drives continuous improvement in performance to objectives and fact based decision making.In collaboration with the site management, set strategic direction for current and future product, systems, work practice, and process improvements.
  • Provide leadership in directing the efforts of management, supervisory and direct labor for the QA Department. Direct, oversee and participate in the recruitment, selection, promotion, termination and performance management of QA personnel.
  • Foster a spirit of collaboration, cooperation, honesty, and integrity while remaining flexible with customer focus.
  • Hold employees accountable for execution of assigned duties, managing defined roles & responsibilities and meeting objectives.


Qualifications

  • 7 or more years experience managing personnel - or equivalent training and/or experience.
  • Strong knowledge of cGMP, GLP requirements, PTC guidelines and ISO 17205
  • Ability to accurately and reproducibly perform arithmetic, algebraic and geometric calculations.
  • Ability to evaluate technical data and to assist in the writing and editing of technical documents.
  • Ability to use judgment, clear problem-solving and decision-making skills.
  • Ability to work under limited supervision and to handle complex problems.
  • Ability to communicate effectively with all levels of the organization.
  • BA/BS in a Science related major

 
 
We are an equal opportunity employer - woman/minorities/disabled/veterans 

 

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