Director, Quality Assurance - Gene Therapy

Amicus Therapeutics, Inc. Cranbury , NJ 08570

Posted 6 months ago

Director, Quality Assurance

  • Gene Therapy
  • Candidates without Gene Therapy specific experience WILL NOT be considered for this role.

  • Position can be based in Cranbury, NJ OR Philadelphia, PA

Position Summary

Amicus Therapeutics is seeking an Director, Quality Assurance

  • Gene Therapy (GTx) QA. The incumbent provides Quality Assurance oversight of GTx development, contract manufacturing, and quality control. Specifically, this position will support the areas of Development, Technology Transfer, and manufacturing for new and existing GTx products.

The Director, Quality Assurance

  • Gene Therapy (GTx) QA position will have demonstrated experience to support new and on-going product development and manufacturing of GTx products. The successful candidate will be responsible for providing QA support for process/analytical risk assessments, clinical manufacturing, scale-up and qualification/validation activities for all GTx products. Additionally, the incumbent will be responsible for ensuring a robust disposition process is in place for each GTx product.

Roles and Responsibilities

The Director, Quality Assurance

  • Gene Therapy (GTx) QA is responsible for:
  • Follows all applicable regulatory requirements, cGMP guidelines, and industry guidance documents as required by the job function

  • Provides QA review and approval of qualification/validation protocols and reports for manufacturing processes, cleaning processes, equipment and facility validation activities

  • Provides QA review and approval of qualification/validation protocols for analytical methods and product specifications

  • Provides QA review and approval for new and existing procedures, master batch records, change controls, deviations and investigations

  • Understanding of Quality by Design (QbD) principles as they relate to GTx manufacturing

  • Represent QA in risk assessment activities for the GTx programs

  • Provides QA oversight of GTx Contract Manufacturing Organizations (CMOs)

  • Ensures all work is performed and documented according to approved standard operating procedures, in general compliance with cGMPs and in a timely manner consistent with agreed upon schedules

  • Proficient in process and data review within respective scientific field of operation in accordance with job responsibility and function, able to troubleshoot product, process, and analytical-related issues

  • Regularly meets with QA management team in the development of best practice standards, KPIs, identification of training needs and optimization of resource utilization

  • Ensure compliance to all compendia and internal requirements (SOPs, Quality Agreements, General and Informational Chapters in multiple compendia as applicable)

  • Performs other duties related to the position when required by management

Requirements

  • Minimum of BS or equivalent in the life sciences or engineering

Experience and Skills

  • Must have a minimum of 7-10 years' experience in the pharmaceutical/biotech industry.

  • At least 5 years' experience with GTx QA is required.

  • Experience with managing direct reports

  • Working knowledge of FDA and EMA GXP regulations and ICH guidance documents

  • Experience in developing, reviewing and approving cGMP related documents (batch records, SOPs, protocols, reports, etc.)

  • Experience in the manufacture of GTx products is desired

  • Experience in reviewing investigations, evaluating root cause and corrective action plans

  • Experience in overseeing and managing CMOs

Travel

  • Domestic and international travel requirements 15-20%
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Director, Quality Assurance - Gene Therapy

Amicus Therapeutics, Inc.