Attralus is a newly established biotechnology company with novel protein therapeutics directed at systemic amyloidosis, which is responsible for a wide range of disease states that are currently underserved by currently available drugs. To meet our strategy of rapidly advancing our novel products into clinical trials and beyond, we seek the services of a GMP Quality expert to lead critical activities within the CMC function. Reporting to the Senior Vice President, Head of CMC, the Director, GMP Quality will lead Attralus’ GMP Quality Assurance activities. As Attralus is a virtual firm, the Director, GMP Quality will be expected to develop and maintain strong strategic relationships with our GMP contract services providers to ensure successful outcomes for Attralus’ products. The Director, GMP Quality will also oversee the development and maintenance of Attralus’ internal GMP Quality Systems. The Director, GMP Quality will work both independently and with cross-functional teams to provide high-quality support of multiple therapeutic projects. The position will function remotely, with occasional travel to Attralus’ San Francisco Bay Area home office, along with onsite work at CMOs as appropriate and safe.


ROLES, RESPONSIBILITIES & EXPECTATIONS (including, but not limited to)

  • GMP Quality oversight of manufacturing, packaging, labeling and distribution vendors 
  • Disposition of Attralus GMP drug substance and drug product, manufactured at various CMOs, including batch record review/approval and issuance of Certificates of Compliance 
  • Quality Agreement draft, review and approval to support contract GMP activities 
  • GMP site audit leadership, including draft, review and approval of audit reports 
  • Specifications review and approval, including evaluation of their justifications 
  • Review and approval of Master Batch Records and SOPs pertinent to Attralus’ products
  • Method qualification/validation review and approval 
  • Real-time virtual QA support for GMP production 
  • Representation of Attralus during investigation and reporting of deviations at CMOs 
  • Support of validation activities at CMOs, including review and approval of validation protocols 
  • Tracking of batch release metrics, including deviations 
  • Management of Attralus’ internal Quality System, including change controls and deviations within these systems as well as tracking those at CMOs 
  • Quality Manual and SOP review and approval in Attralus’ internal Quality System 
  • Management of GMP documents in Attralus’ internal Quality System 
  • Development and maintenance of a GMP compliant document control function with appropriate processes, procedures, and practices, including management of an Electronic Document Management System 
  • Development and implementation of a supplier management program, including establishment of an approved supplier list and their associated Quality Agreements 
  • Development and implementation of internal and external audit programs, including establishment and execution of a regular schedule for audits and follow-up on audit observations until adequate closure 
  • Establishment and maintenance of Attralus’ internal GMP training program 
  • Establishment and maintenance of a work environment that fosters open communication, collaboration, integration, and teamwork 
  • Staying abreast of changes in applicable regulations, directives and guidelines, and determining their impact on Attralus’ programs


REQUIREMENTS/QUALIFICATIONS

  • Bachelor's degree or higher in a scientific discipline, with a minimum of 12 years of experience in the biotechnology or pharmaceutical industry 
  • Experience in GMP Quality Assurance is essential 
  • Strong understanding of cGMP, FDA and EMA guidance, and ICH guidelines is required 
  • Experience with GMP manufacturing and testing of biologics, especially recombinant proteins, is highly desirable 
  • Experience in working with CMOs is preferable 
  • Authorship of regulatory filings experience is a plus 
  • Excellent written and verbal communications skills, both internal and external, are essential 
  • Excellence in teamwork, including both remote and face-to-face interactions, are also essential 
  • Project management and/or team leadership experience is a plus
This position has been filled.