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Quality Site Head

Posted 28 days ago

  • Expiry Date: 19 April 2021

Title:Product Quality Lead

Location:Remote during COVID

Salary:$200,000-$220,000 DOE + bonus

Term:Permanent

Summary:

We are currently seeking a Quality Site Head to work for an incredible, global life sciences firm. The organization is transforming individuals lives for the better, and they are looking for a seasoned professional to join a successful and growing team. As a Site Quality Head, you will be responsible for providing leadership to the Site Quality organization to ensure that teamwork, high morale and innovation are fundamental components of a world-class team. In addition you will Develop, implement and monitor Quality programs, policies and procedures to ensure compliance with GxP standards, ISO standards, corporate policies, FDA and other regulatory body regulations and guidelines

The Site Quality Head's Responsibilities:

  • Provide leadership to the Site Quality organization to ensure that teamwork, high morale and innovation are fundamental components of a world-class team

  • Develop and execute the Quality strategy commensurate with the overall plan for the company. Ensure alignment with customer needs and linkage with the overall Quality and business strategies. 

  • Implement continuous improvement initiatives to drive Quality programs and ensure maximum productivity. Ensure systems are world-class and meet the needs of all internal and external constituencies with an emphasis on process, quality, productivity, budget control, and profitability. 

  • Develop, implement and monitor Quality programs, policies and procedures to ensure compliance with GxP standards, ISO standards, corporate policies, FDA and other regulatory body regulations and guidelines.

The Quality Product Lead’s Qualifications:

  • Bachelors Degree in a Life Sciences, engineering or Quality Management or related science discipline

  • Substantial direct job related experience in GMP facility manufacturing products regulated by Center for Biologics Evaluation and Research (CBER), Center for Drug Evaluation and Research (CDER), or Center for Devices and Radiological Health (CDRH) with significant experience in Quality Management

  • Aseptic Practice & Clean Room environment experience

  • Experience with Warning Letters and working directly with the FDA

If you are a Site Quality Head that ticks all the boxes, please respond with an updated resume

Please note that due to the nature of this position, my client is only accepting US Citizens or Green Card holders currently