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Manager / Senior Manager, Technical Quality Assurance

Position Summary:

The Manager / Senior Manager, Technical QA will provide product specific quality oversight and management of contract manufacturing organizations (CMO) such as drug substance and drug product manufacturers, packagers, testing labs and critical material suppliers. This position will serve as the QA subject matter expert (SME) in CMC meetings and will be the key point of contact representing QA for oversight of all CMOs in the assigned product from development to commercialization. This position will collaborate with other functional groups to ensure that products and services provided by CMOs comply with cGMP requirements and all other applicable regulations. An extensive collaboration with Process Chemists, Formulators, Analytical Chemistry, Supply Chain, and other functions at Achaogen will be required to establish and implement a risk-based quality oversight model.

Essential Functions:

  • Serve as a QA member in the CMC Team and have the ability to manage across functional boundaries.
  • Develop master batch records with Process Chemists and Formulators.
  • Participate and sometimes lead external audits for the assigned CMOs, labs and suppliers.
  • Responsible for document control records of new and revised test methods, work instructions, specifications, protocols, reports, forms, and templates.
  • Review, approve and manage internal and external product documentation (i.e. master batch records, executed batch records, test methods, specifications, protocols, reports, forms, and etc.).
  • Coordinate the review and approval of internal and external deviations, investigations, CAPA and Change Control.
  • Negotiate Quality Agreements and define Statements of Work pertaining to quality requirements.
  • Write procedures and work instructions and support document review and approval of QA documents as requested.
  • Support Quality Management System (QMS) projects and activities as needed.
  • Provide data for trending for the QMS for the Quality System Management Reviews (QSMR).
  • Provide information for Annual Product Reviews or routine reports as needed.
  • Support GxP QA Operations in document review as needed.
  • Support FDA inspections and preparations for Pre-Approval Inspections (PAI) and internal audits.

Preferred Experience:

  • At least 10 years of GMP quality experience in pharmaceutical/biotechnology industry.
  • Batch record review and Quality Control experience.
  • Small molecule experience (solid dose, API, parenterals).
  • Working knowledge of 21CFR Parts 11, 210, 211, 820; ICH, and GxP regulations.
  • Computer proficiency in Microsoft Word, Office, Excel, PowerPoint, Adobe Acrobat Pro, electronic database system, etc.
  • Clinical and commercial experience and ability to be flexible without losing quality focus.

Preferred Education:

  • BS/BA in scientific discipline or equivalent.

Preferred Additional Skills:

  • Strong organizational and attention to details skills.
  • Ability to adapt to a fast paced and changing work environment. 
  • Displays emotional resilience and the ability to withstand pressure.
  • Communication skills in regard to interaction within GxP and associated customers.
  • 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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