Senior Director, Quality Assurance, GCP

Redwood City, CA 94065

Posted: 10/05/2020 Employment Type: Direct Hire Industry: Clinical & Scientific Job Number: 17992

Job Description

The Senior Director, Quality Assurance (QA) is responsible for leading and managing the QA systems across all departments and functions to ensure that QA initiatives and plans are executed and maintained in full compliance with GXP requirements. This includes addressing issues from QA management system oversight and effectively implementing QA enhancement activities.


  • Lead and manage all QA plans and initiatives

  • Lead and manage QA system improvement initiatives across all departments and functions

  • Ensure an effective review on the continuing suitability and effectiveness of QA systems at defined intervals

  • Direct and support the resolution of QA problems to ensure consistency with industry and QA standards

  • Support and supervise QA governance through review of project documents, risk assessments, and QA plans

  • Identify and manage continuous improvement projects

  • Lead the preparation and execution of internal, external, and regulatory audits on the site.

  • Participate in or manage QA assessments related to introduction of new products into the facility.

  • Review and approve high level QA system documents

  • Ensure that coordinated contact is maintained with other functions, including training and sharing of best practices

  • Consult with functional leads regarding ongoing and emerging QA requirements (e.g., whether an SOP is required vs. a Work Instruction, whether an SOP should be revised, addressing training needs of the functional group, etc.)

  • Escalate all critical and major QA issues to senior management to ensure timely resolution

  • Perform formal and informal reviews of compliance performance at the functional area and at the individual level,  and propose corrective actions

  • Anticipate potential risks associated with product QA and regulatory compliance

  • Contribute significantly to the development execution of best practices within the scope of GXP compliance and regulatory requirements


  •   Minimum 10 years of QA experience in the biopharmaceutical industry

  • Expert in QA system implementation & improvement, including SOP development, training, external & internal auditing, regulatory inspection, change control, data integrity, customer complaint management, deviation Investigation, risk management, external supplier/vendor QA systems, QA agreements, QA metrics, and Corrective and Preventive Action (CAPA) management

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Felicia Id-Deen

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