Senior Manager, External Quality Operations

The Senior Manager, External Quality Operations will be responsible for managing external quality operations of gene therapy products. This role includes ownership of the external disposition process, QA liaison to contract manufacturing organizations (CMO), contract testing labs and distribution centers including review and approval of quality system records including, but not limited to batch records, deviations and qualifications. The individual will also work cross-functionally to develop, implement, and improve processes to support the start-up and operation of internal GMP manufacturing capabilities.

Essential Functions and Duties

  • Ownership of the batch disposition process for externally manufactured products
  • Serve as primary liaison to CMOs, CTLs, and distributors
  • Oversight of quality activities associated with manufacturing and testing of clinical materials
  • Batch record review and approval
  • Tech Transfer and Validation support
  • Review and approval of QC activities including: testing, method qualification/validation, and stability protocols/reports
  • Support regulatory authority inspections and partner audits
  • QA oversight of quality system records including: Deviation, CAPA, Change Control, and Investigations
  • Support establishment and management of the quality metrics program

Skills and Experience

  • Bachelor’s degree in life sciences, engineering, or equivalent
  • Minimum 8 years of experience in the pharmaceutical or biotech industry in QA operations and direct experience working with Quality Systems, specifically batch record review and disposition
  • Ability to lead, problem solve, and work autonomously in a dynamic manufacturing environment
  • Ability to apply a phase appropriate, risk-based approach to QA operational decisions
  • Comprehensive knowledge of GMP regulations and guidelines
  • Experience with tech transfer, qualifications and validations
  • Direct experience with biologics Drug Substance and Drug Product manufacturing
  • Excellent technical, organizational, communication, and interpersonal skills are essential
  • Flexibility to accommodate to rapidly changing priorities and deadlines
  • Auditing experience a plus

Interested candidates should forward a cover letter and resume / CV to careers@homologymedicines.com