Quality Assurance Manager, Biologics - Eurofins CDMO Alphora, Inc.

• Responsible for the general oversight of all quality and GMP activities within the Biologics operating unit related to facility, operations and analytical.
• QMS Development
  • Participate in the development and establishment of GMP quality management systems specific to the development, manufacture, and testing of Biologics. Biologic specific requirements will be incorporated into existing QMS for clinical and commercial API and Drug product
  • Participate in the continuous improvement of quality systems, policies and procedures based on quality system data/KPIs and Regulations.
  • Write, review, and approve Standard Operating Procedures (SOPs). 
  • Contribute to preparation and approval of various quality documents as a Quality SME.
• Quality Oversight
  • Provide production support including equipment and line clearances.
  • Perform oversight of batch manufacturing and final product packaging operations
  • Review/assess change controls.
  • Review/develop system qualifications for production and analytical equipment.
  • Maintain vendor qualification program for Biologics program
  • Participate/lead quality oversight initiatives as assigned.
• Deviations and Investigations
  • Responsible for developing investigation plans, leading investigations, root cause analysis, risk and impact assessments, determination of CAPA, and final report issuance.
  • Provide support, guidance and training to QA Associates and other departments.
  • Collaborate with clients as required.
• Master Record Approval
  • Responsible for the review and approval of GMP documentation – Master batch records, Specifications, Test Methods, Sampling/Labelling/Analysis Forms, etc.
• Batch Review and Release
  • Review executed batch records and production cleaning study reports for accuracy, completeness and compliance to established CGMP or other regulatory standards.
  • Support assignment of batch disposition to Product’s manufactured/tested at Alphora – ensure all testing and manufacturing records have been reviewed for compliance to GMP and SOPs prior to assignment of disposition.
  • Compile batch release documentation packages and related certification statements.
• Testing Data Review and Release
  • Review analytical data and protocols for standard qualification, stability, method qualification and method validation protocols for accuracy, completeness and compliance.
  • Review quality control lab data for raw materials, in-process controls, intermediates and APIs for accuracy, completeness and compliance to CGMP or other applicable regulatory standards.
• Audit Support
  • Assist in preparation/coordination of customer and regulatory agency audits.
  • Support and/or direct internal company audits.
• Regulatory Support
  • Assist in development of the Chemistry, Manufacturing and Controls portion of the client. submissions in support of IND’s, NDA’s, and BLA’s as assigned.
• Contribute to QA department meetings by providing project status reports as well as identifying and leading continuous improvement activities.
• Participate in opportunities to develop knowledge of CGMP and business operations.
• Represent Alphora QA on client project’s, as assigned.

The ideal candidate will:

• 5-10 years of pharmaceutical quality assurance / control in GMP setting
• Experience with development, manufacture and testing of pharmaceuticals
• Experience with Biologic pharmaceutical, in particular mAbs and ADCs is an asset
• Sterile fill / aseptic processing experience preferred.
• Minimum education: B.Sc. – Biochemistry, Microbiology or related discipline