Quality Control Manager

Role Summary

Quality Control Manager. Lead on-site management of the Quality Control Bioanalytics team, ensuring cGMP compliance and coordination of testing, staffing, and laboratory operations.

Responsibilities

• Lead and supervise Bioanalytics Laboratory 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 scheduling and execution of testing, including routine analyses and technology transfer support for products within Bioanalytics Laboratories.
• Provide technical expertise to lab staff and cross-functional teams; lead daily lab operations in scheduling, project planning, materials management, equipment, and personnel.
• Review and approve controlled documents (SOPs, Analytical Methods, Protocols, and Reports) related to Bioanalytics Lab activities.
• Ensure lab operations align with GMP, Good Documentation Practices, Safety, and Laboratory Controls; represent the lab during audits/inspections and interact with regulatory agencies as needed.
• Oversee Bioanalytics Lab Quality Systems records (lab investigations, Deviations, CAPAs, Change Controls); manage staff training and development.
• Support continual improvement and LEAN initiatives; ensure changes impacting product quality are assessed; investigate and document deviations; maintain complete and compliant records.
• Collaborate cross-functionally to ensure Quality Management System processes are followed; alert senior management to quality, compliance, supply, and safety risks.

Qualifications

• Required: High school diploma/GED with 12 years of quality experience; or Associate’s degree with 10 years; or Bachelor’s with 5 years; or Master’s with 3 years; or Doctorate, plus directly managing people or leadership experience.
• Preferred: Advanced degree in a scientific field.

Skills

• Knowledge of HPLC/UPLC, Capillary Electrophoresis (CE SDS, cIEF, and/or cOligo), UV, Osmolality, pH, polysorbate, subvisible particles, appearance, color and clarity.
• Technology transfer, analytical method validation, and ensuring project deliverables meet timelines.
• Strong data analysis, problem-solving (root cause analysis), GMP application in QC, and leadership/mentoring abilities.
• Excellent interpersonal, verbal, and written communication across organization levels; ability to manage a team in a fast-paced environment.
• Ability to coordinate cross-functional project teams and drive LEAN/operational excellence initiatives.

Education

• As applicable to above qualifications (Bachelor’s/Master’s/Doctorate in a relevant field).

Additional Requirements

• Experience with regulatory inspections and internal/external audits; familiarity with Quality Management System processes.
• Ability to collaborate across functions and build relationships with partners; capable of leading multi-functional teams and delivering on schedule.