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Quality Director

  1. Central
Arizona
  1. Contract
Competitive
  1. Compliance / Quality Assurance
13-02-2024
31670

This vacancy has now expired

Quality Director – Pharmaceuticals - Arizona

We have an exciting opportunity for a Quality Director to join a Global biotech company located in Arizona for an initial 24-month contract.

An exciting project with lots of opportunity to learn new technology and develop current skills within a fast paced $1 billion project. This fantastic client offers the opportunity to work within a large-scale environment with cutting edge technology.

Essential Duties and Responsibilities for this Quality Director role include, but are not limited to, the following:
  • Direct oversight of Quality Assurance, Quality Compliance, Configuration Management, Quality Release, Quality Engineering and Document Control departments.
  • Coordinate and participate in FDA Inspections, remediations and customer audits.
  • Oversight of the site supplier qualification and auditing program.
  • In collaboration with global Quality leadership, interprets regulations and guidelines to develop policies and standards, identify gaps and redundancies and coordinates and implements remediation
  • Provide QA oversight during site media fills.
  • Lead quality investigations on an as needed basis.
  • Provide input on site validation activities.
  • Lead and report progress of Quality Engineering projects as required
  • Lead and report progress of various quality improvement projects within the quality, laboratory and manufacturing areas
Desirable Experience:
  • BS degree in (Biological) Science, Engineering, or Operations Management; Advanced Degree (s) preferred
  • Position requires a seasoned Quality Assurance professional with a minimum of 15 years of experience in GMP biopharmaceutical/vaccine companies
  • Must have a track record of success and a broad understanding of contemporary quality practices as they apply to product development/clinical manufacturing and commercial operations.
  • Proven expertise in the design and implementation of quality processes in a world-class medical device/pharmaceutical/vaccine manufacturing organization
  • Must have technical knowledge of product design, manufacturing, process design and improvement.
  • Must have a track record of success and a broad understanding of contemporary quality practices to the position.
If this role is of interest, please apply now.
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