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Director of Quality Control

Posted on Sep 28, 2021 by Elevate Direct

Cork, Ireland
Research
Immediate Start
Annual Salary
Full-Time


Director of Quality Control

The primary responsibility of the QC Director is to ensure that all QC laboratories provide compliant, timely and efficient quality control service. The candidate will also mentor, develop and deliver performance review of QC Managers.

Responsibilities:



  • Responsibility for release testing of raw materials, commercial and clinical process intermediates, and commercial drug substances.

  • Responsibility for all activities related to New product introduction of to the labs.

  • Responsibility for Analytical Equipment Lifecycle management

  • Run laboratory test and release lead times to ensure timely product disposition.

  • Ensure compliance to regulatory requirements

  • Ensure Safety and Quality standards are optimally maintained and align with J&J global guidelines and regulatory expectation.

  • Ensure appropriately trained resources are deployed.

  • Budget responsibility including CAPEX, headcount, and expenses

  • Responsibility for performance and development of all Site Quality Control associates

  • Drive continuous improvement.


Have you?

  • Track record in leading cross-functional teams.

  • Ability to work across interpersonal boundaries through influence and partnering for changes requiring agreement from all partners.

  • A bachelor's degree in engineering, Science or equivalent technical discipline.

  • A consistent record in Quality related to manufacturing is required.

  • People management and leadership experience.

  • Extensive knowledge of chemical, biochemical, and microbiological concepts is required.

  • Knowledge of cGMP regulations and FDA/EU guidance is required.

  • Strong partnering with multiple internal and external partners.

  • A strong scientific leader with a clear understanding of regulatory expectations.

  • Ability to hire, develop and retain top talent for QC operations.

  • Exposure to an international working environment in previous roles is preferred

  • Regulatory and inspection experience is preferred.


This is an excellent opportunity to join an established company as it expands its Irish operations. This is a permanent Full time opportunity and comes with excellent salary and full benefits package.


Reference: 1337792130

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