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Associate Director / Director, Quality Compliance

Position Summary:

The QA Compliance Director/AD will support the overall compliance and inspection readiness for Achaogen.  This includes overseeing internal and external Pre-Approval Inspection preparations, internal and external audits, inspection trend development, Quality Site Management Review and GLP/GMP annual/monthly training. Documents will be generated both internally and externally and it is necessary to ensure full compliance with internal quality standards, cGxP (focus GMP and GLP), EU, and ICH regulatory requirements.

Essential Functions:

  • Lead audits of external Contract Manufacturing Organizations (CMOs) and Laboratories (CLOs).
  • Write audit reports and track audit responses for internal and external audits.
  • Maintain audit and inspection history of all CMOs and CLOs.
  • Develop and present GMP Training for internal employees and contractors.
  • Ensure internal IT systems are compliant to 21 CFR Part 11 as required.
  • Lead Pre-Approval Inspection Preparations internally and externally (GMP/GLP) and partner with internal GCP.colleagues that will lead on-site inspections.
  • Write SOPs and Policies related to compliance and other quality documents as needed.
  • Develop and oversee product complaint system.
  • Develop and present Quality Site Management Reviews (QSMRs).
  • Develop and oversee Quality Risk Management program and support product teams as needed.
  • Strategize for inspection preparations or for investigations supporting products.
  • Interacting with global regulatory agencies including the FDA and EMA.
  • Oversee and support CAPAs and deviations related to compliance.
  • Travel up to 35% for both domestic and international.

Preferred Experience:

  • At least 15 years of quality experience in pharmaceutical/biotechnology industry.
  • Small molecule API and drug products (capsules, tablets, parenterals) experience.
  • Working knowledge of EU and US regulations; ICH Q9 and GLP / medical device experience is a plus.
  • Extensive experience leading audits internally and with CMO/CLOs and experience with health authorities.
  • Computer proficiency in Microsoft Word, Office, Excel, PowerPoint, Adobe Acrobat Pro, electronic database system, etc.

Preferred Education:

  • BS/MS/PhD (or equivalent experience) in scientific discipline or equivalent.

Preferred Additional Skills:

  • Strong organizational and attention to details skills.
  • Able to work in a dynamic environment with changing priorities.
  • Committed to the values of integrity, accountability, transparency, scientific rigor and drive.
  • Current US work authorization required.
  • Ability to travel domestically and internationally. 
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