Quality Assurance Senior Manager

Role Summary

Quality Assurance Senior Manager – B23 Drug Substance Mfg. Lead the B23 Drug Substance QA team and act as the Quality Leader for GMP Operations within the B23 drug substance manufacturing facility. Provide QA leadership and oversight in support of the operational team’s key responsibilities, coordinate with cross-functional partners, and contribute to a culture of Safety and Quality at ATO.

Responsibilities

• Meet site demands for drug substance clinical and commercial programs in the B23 and B23E manufacturing area
• Identify and implement continuous improvement opportunities within processes and systems
• Staff management: recruit, train, oversee, and evaluate QA staff; prioritize professional development; ensure safety and quality culture
• Quality oversight and leadership: ensure Quality Management System processes are implemented; provide direction on investigations, CAPAs, Change Control; review/approve records and reports; collaborate across the enterprise
• Continuous improvement: participate in cross-functional improvement initiatives, regulatory inspection readiness, internal audits; engage in Operational Excellence programs
• Complete required training; alert senior management to significant risks; provide additional duties within the Quality Management System as needed

Qualifications

• Basic Qualifications:
  • Doctorate degree and 2 years of quality assurance experience OR
  • Master‚Äôs degree and 6 years of quality assurance experience OR
  • Bachelor‚Äôs degree and 8 years of quality assurance experience OR
  • Associate‚Äôs degree and 10 years of quality assurance experience OR
  • High school diploma / GED and 12 years of quality assurance experience
• Minimum 2 years experience directly managing people and/or leading teams, projects, programs, or resource allocation

Preferred Qualifications

• Excellent interpersonal and communication skills; ability to work in a matrix environment
• Experience participating in, managing, and/or responding to health authority inspections and audits
• Project management experience; ability to lead cross-functional teams and manage change
• Strong data analysis and case development skills
• Experience driving process improvements; knowledge of Operational Excellence, Lean, Six Sigma
• Experience in cGMP production environments across QA, manufacturing, analytical labs, validation, and process development
• Experience across product development stages (Phase 1 to commercial) a plus
• Experience in Cell Culture, protein purification, and bioassays a plus
• Experience with Quality Management Systems (Change Control, Risk Management, Disposition)
• Experience with computer systems (MES, PI data historian, Delta-V) and Veeva for CAPA investigations
• Biology, Chemistry, or Engineering degree desirable