Director of Quality Assurance, GLP

Saint Paul, United States

WuXi AppTec

Posted on: June 24, 2020

Closing: July 24, 2020

Salary: 150,000 – 174,999

Position Type: Full Time

Job Description

Overview
Responsible for developing, implementing and representing the quality assurance programs as well as recommending measures to ensure the fulfillment of management quality objectives.   

Responsibilities

  • Drives the GLP principles and international laboratory quality standards to laboratory areas.
  • Ensures regulatory trends are monitored and communicated to all laboratory areas.
  • Assures adequate QA support and oversight for all regulated areas and other selected laboratories to ensure adherence to high quality standards and compliance with all applicable regulatory requirement, in particular GLP compliance.
  • Review/Approve site operation and QA SOPs.
  • Maintain active dialog, close communication and working relationship with all levels of laboratory personnel and line management on purpose, direction and goals of quality management.
  • Assures conformance with authorized policies and procedures.
  • Directs improvements, development, and implementation of Quality Assurance (QA) programs and procedures. Assures consistency with other WuXi AppTec sites.
  • Oversees quality auditing program and GLP practices.
  • Assures health authority inspections and accreditation/certifications are fully supported ad ensure appropriate and consistent inspection practices.
  • Participates in the review and development of Client Quality Agreements.
  • Provides direction for consistency in quality assurance operations and regulatory interpretations.
  • Directs development and presentation of compliant training program for GLP and assures employees receive appropriate training.
  • Assures suppliers are assessed for compliance to applicable quality and regulatory requirements
  • Directs operations of the QA Department.
  • Directs the review of new technology, methods, and equipment with respect to QA.
  • Makes appropriate recommendations for correction and improvement when necessary.
  • Conducts employee performance appraisals in a timely and objective manner.
  • Recommends hire/promotion/discharge and salary changes and acts on employee problems.
  • Contributes to the overall operations and to the achievement of departmental goals
  • Other duties as assigned

Qualifications

Experience / Education   
  • Bachelor degree in scientific discipline.
  • Education and experience to meet applicable regulatory requirements.
  • At least of 7 years of Quality Assurance experience in GLP-regulated environment.
  • Experience in software documentation, software development life-cycle management and 21 CFR Part 11 compliance.
  • Strong experience and direct responsibility for management of Quality Assurance programs
  • Strong knowledge of pertinent national and international regulations pertaining to medical devices, biopharmaceutical, and aseptic processes
  • Excellent leadership and communication skills
Preferred experience:
  • Working knowledge of 21 CFR parts 11, 58, 820, ISO 13485 and/or ISO 17025, standards. Additional knowledge of 21 CFR parts 210/211, 610, 1270/1271 and AATB standards is a plus.
  • Professional certifications, such as Certified Quality Improvement Associate (CQIA), Lead Auditor. 
Knowledge / Skills / Abilities:
  • Strong leadership in regulated environment
  • Proficient in Oral & Written communication skills
  • Need to be able to read, write and understand English
  • Proficient in Microsoft (Excel, Word, Outlook, Visio)
  • Ability to work in a team environment and independently as required
  • Thorough understanding of Good Laboratory Practices and ISO standards.
  • Knowledge of Quality Management System software
  • Travel is required as needed to company or client sites

WuXi AppTec

Posted on: June 24, 2020

Closing: July 24, 2020

Salary($): 150,000 – 174,999

Position Type: Full Time

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Career Focus: Preclinical, Quality,