Quality Control Manager

Role Summary

Quality Control Manager responsible for on-site management of the Quality Control Bioanalytics team, ensuring cGMP compliance and alignment of facilities, equipment, materials, processes, procedures, and products with regulatory requirements.

Responsibilities

• Lead and supervise bioanalytics staff; maintain weekly lab schedule and prioritize daily tasks.
• Provide quality oversight to ensure processes follow current Good Manufacturing Practices (cGMP).
• Ensure facilities, equipment, materials, organization, processes, procedures and products align with cGMP and applicable regulations; review, approve, and track cGMP documents and records including nonconformance and CAPAs.
• Coordinate testing scheduling and execution, including routine analyses and technology transfer support.
• Provide technical guidance to lab staff and cross-functional teams; lead daily lab operations (scheduling, project planning, materials, reagents, equipment, staff).
• Review and approve controlled documents (SOPs, analytical methods, protocols, reports).
• Ensure lab operations comply with GMP, Good Documentation Practices, safety, and lab controls; represent lab during audits and inspections; interact with regulatory agencies during on-site inspections.
• Oversee Quality Systems records including investigations, deviations, CAPAs, and change controls.
• Select, develop, and evaluate staff; manage training assignments and accuracy.
• Support continual improvement and LEAN initiatives; ensure changes impacting product quality are assessed; investigate deviations per procedures; maintain complete and accurate records.
• Collaborate cross-functionally to ensure Quality Management System processes are followed; alert senior management to quality, compliance, supply, and safety risks.
• Support internal/external audits and inspections as part of the audit/inspection management team.

Qualifications

• Basic Qualifications:
  • High school diploma/GED and 12 years of Quality experience
  • Associate‚Äôs degree and 10 years of Quality experience OR
  • Bachelor‚Äôs degree and 5 years of Quality experience OR
  • Master‚Äôs degree and 3 years of Quality experience OR
  • Doctorate
• Experience directly managing people and/or leadership experience leading teams, projects, programs, or resource allocation.
• Preferred Qualifications:
  • Advanced degree in scientific field
  • Knowledge in HPLC/UPLC, CE (SDS, cIEF, and/or cOligo), UV, Osmolality, pH, polysorbate, subvisible particles, appearance, color and clarity
  • Familiarity with technology transfer; validating analytical methods and meeting timelines
  • Strong data analysis and root-cause problem-solving skills
  • GMP experience in Quality Control; ability to develop, coach, and mentor employees
  • Excellent interpersonal, verbal, and written communication
  • Experience managing a team in fast-paced environments; ability to work in a matrix organization
  • Leadership in LEAN initiatives; establish and review department goals, strategies, and KPIs
  • Experience with laboratory equipment and computer systems; strong leadership and negotiation skills
  • Innovative thinking; exposure to Operational Excellence
  • Ability to coordinate multi-functional project teams and deliver on schedule

Education

Additional Requirements

• No explicit travel or physical demands noted as essential beyond standard lab work activities.