Associate Director, Quality Operations

4 weeks ago

Denver, United States Germer International Full time

Our pharmaceutical client is looking for an Associate Director of Quality Operations to be responsible for the Site Quality Assurance Operational Unit, including main Customer Program QA Point of Contact, Deviation and CAPA Management, Batch Record Release & Review, and Shop Floor QA Oversight.

  • You will provide leadership for the Quality Operations in accordance with directions from the Director of Quality Assurance and Control based on the organization's policies, applicable laws, and guidance.
  • Quality and compliance activities to include the direction of all related operations pertaining to release activities (QA), and continuous improvement (including inspection readiness for all manufacturing and operational areas).
  • The Associate Director is responsible for ensuring that adequate resources are retained, trained, qualified, validated, and deployed timely to ensure compliant material is released per site schedules.
  • Ensures cGMP throughout the product life cycle is maintained and compliant with company quality and compliance policies, and practices based on applicable regulation and guidance.
  • Responsibilities include goal alignment with the Director of Quality Assurance and Control. Goal realization includes achievement consistent with site strategy, developing employees; planning, assigning, and managing work; and continuous improvement, addressing complaints and resolving problems.
  • Participates directly in customer and government quality audits and inquiries from a quality operational perspective; meaning in regard to material production, deviation resolutions, risk documentation, and release decisions.
  • Designee to the site Quality Council.
  • Accountable for the operational budget and financial performance of the site Quality Operations Organization.
  • Responsible for Product Quality Management activities to include change management, investigation and CAPA management, product field performance (complaint management), and product performance trending, and reporting for site consistent with customer quality agreements. Direct and participate in site level continuous improvement initiatives related to operational impacts, including their quality and regulatory requirements. Manage and drive operational unity Quality metrics within the site to SOP requirements, expectations, and goals. Ensure timely reporting of metrics and remediation plans are in place where metrics do not meet target.


EDUCATION and/or EXPERIENCE

Bachelor's Degree from college or university; and 10 years of related experience; or equivalent combination of education and experience.

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