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Quality Director

  1. Central
  1. Contract
Competitive
  1. Compliance / Quality Assurance
21-09-2023
31670
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.

The candidate must have the rights to work in the location stated in the job advert.

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