QA Manager

Position Summary

QA Manager will support managing quality assurance lot release activities for the disposition of drug substance (DS), drug product (DP) and finished drug product manufactured at Eidos’ contract manufacturing organizations (CMOs). This individual will support as a quality liaison with assigned CMOs, including management of the review and approval of manufacturing batch records, certificates of analysis and the issuance of certificates of compliance. The Eidos, QA Manager will ensure that the CMO SOPs and batch records are in compliance with cGMPs. This position will serve as the primary technical quality reviewer and approver for deviations, change records and CAPAs generated from or pertaining to our CMOs. This individual will interact closely with CMOs and internal stakeholders such as quality control, manufacturing, regulatory affairs and supply chain.

Essential Duties and Responsibilities

  • Perform quality review and provide guidance of quality events (deviations, change requests, supplier notifications, etc.) as documented by contract manufacturers and manufacturing operations departments
  • Represent QA on project teams responsible for drug substance, drug product and finished drug product manufacturing and testing
  • Review drug substance, drug product master and manufacturing batch records from CMOs, including related documents such as specifications, analytical and microbiological methods, stability study protocols and label proofs
  • Manage lot release activities and communication of lot release schedules to key stakeholders
  • Communicate manufacturing deficiencies/non-conformances to management and work with vendors to ensure timely resolution
  • Participate in the GMP vendor qualification and audit programs and monitor CMO performance
  • Review process and method validation protocols and reports
  • Review analytical test results to ensure compliance with approved specifications
  • Assist in updating CMC sections of regulatory and quality documents (INDs, IMPDs and Annual Reports)
  • Participate in vendor audit
  • Participate in hosting regulatory inspections
  • Participate in internal and external project team meetings
  • Write and review SOPs and quality assurance procedures
  • Other duties as assigned

Qualifications

  • Bachelor’s degree or higher in science, mathematics or engineering required
  • Minimum 10 years of experience in a quality assurance role in the pharmaceutical industry required
  • Must have previous experience with managing pharmaceutical CMOs both international and domestic
  • Extensive knowledge of US and European drug substance and drug product GMP requirements and associated guidelines
  • Experience in the identification and resolution of GMP quality and compliance issues
  • Comfortable working in a virtual bio-pharmaceutical organization with multiple global third-party providers
  • Strong planning and time management skills with ability to prioritize workload
  • Ready to embrace Eidos’s core values and diverse corporate culture
  • Up to 15% of domestic and international travel required