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QA Director, GCP-CLS

Company: Labcorp
Location: Indianapolis
Posted on: September 16, 2021

Job Description:

Job Overview:

  • Develop and effectively communicate CLS regulatory strategies to both internal and external stakeholders
  • Lead successful CLS regulatory change management initiatives.
  • Propose and create appropriate organizational metrics/dashboards demonstrating quality and compliance
  • Be the solutions partner to operational leaders driving business strategies, a strong culture of quality and compliance and continuous improvement
  • Communicate escalation issues to management in a timely manner implementing appropriate functional and business solutions and providing regular update
  • Negotiate, influence and effectively manage constructive crucial conversations with business partners and external stakeholders
  • Partner with operational leaders to ensure stakeholder buy-in, resources available and multidisciplinary team in place to drive strategic business process improvement initiatives
  • Ensure appropriate interpretation of applicable quality regulations/standards and ensure appropriate policies and procedures are revised/created
  • Develop resource strategies to support the functional needs and ensure recruitment, training etc. is aligned to the strategy
  • Mentor RC&QA and operational resources, to drive a quality culture
  • Complete thorough, timely and well documented performance evaluations providing objective feedback to the individual
  • Ensure Regulatory Compliance and Quality Assurance (RC&QA) management responsibilities, as indicated in applicable controlled documents, are followed
  • Partner with appropriate internal stakeholders to set and manage the functional budget
  • Act as the RC&QA Leadership Team's delegate
  • Represent Covance in external associations/forums/organizations, as an industry SME
  • Primarily remote with some required travel globally and domestically
  • Perform other duties, as assigned by management

Education/Qualifications:

  • A minimum of a Bachelor’s Degree in Life Sciences preferred (or equivalent Life Science experience)
  • Postgraduate degree (MSC or equivalent) in science or management related discipline, preferable
  • Experience may be substituted for education

Experience:

  • 16 years in regulatory environment (experience in GXP roles)
  • Experience & regulatory expertise of industry quality systems/standards
  • Ability to effectively communicate functional strategy with external parties
  • Ability to distill critical information

Keywords: Labcorp, Indianapolis , QA Director, GCP-CLS, Other , Indianapolis, Indiana

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