Quality Control Manager

Role Summary

Quality Control Manager responsible for on-site management of the Quality Control Bioanalytics team, ensuring adherence to cGMP and regulatory requirements, leading daily operations, and driving continual improvement within the Bioanalytics Laboratory.

Responsibilities

• Lead and supervise QC 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 processes, procedures, documents, and records (including nonconformance records and CAPAs)
• Coordinate testing scheduling and execution including routine analysis and technology transfer support
• Provide technical guidance to lab staff and cross-functional teams
• Manage daily Bioanalytics Lab operations: testing scheduling, project planning, materials, reagents, equipment, and 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 the Bioanalytics Lab during internal/external audits and inspections; interact with regulatory agencies during on-site inspections
• Oversee Quality Systems records: investigations, deviations, CAPAs, and Change Controls
• Develop, evaluate, and train laboratory staff; manage staff training assignments
• Support continuous improvement and LEAN initiatives
• Assess changes potentially impacting product quality; investigate and document deviations per procedures
• Ensure records are complete, accurate, and compliant with procedures and cGMP
• 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: High school diploma/GED with 12 years of quality experience; or Associate‚Äôs degree with 10 years; or Bachelor‚Äôs with 5 years; or Master‚Äôs with 3 years; or Doctorate
• Experience directly managing people and/or leadership experience leading teams, projects, or resources
• Managerial experience may run concurrently with required technical experience

Preferred Qualifications

• Advanced degree in scientific field
• Strong knowledge in HPLC/UPLC, Capillary Electrophoresis, and general chemistry testing (e.g., UV, Osmolality, pH, polysorbate, subvisible particles, appearance, color, clarity)
• Familiarity with technology transfer; experience validating analytical methods and ensuring timelines
• Analytical skills to evaluate data and apply root cause analysis tools
• Leadership and GMP experience in a Quality Control setting; ability to coach and mentor
• Excellent interpersonal, verbal, and written communication across organization levels
• Experience managing a team in fast-paced environments; ability to work in a matrix organization
• Ability to lead innovative projects to advance efficiency and LEAN principles
• Establishment and review of department goals, strategies, and KPIs
• Experience with laboratory equipment and computer systems; strong leadership and negotiation skills
• Innovative thinking and ability to transform work organizations; exposure to Operational Excellence
• Ability to coordinate multi-functional project teams and deliver on schedule

Education

• Details not specified beyond qualifications above; degree level as listed in Basic/Preferred Qualifications

Additional Requirements

• No application instructions or external links included