Strategic Lead, QC Analytical & Method Validation

GBI Bio; Fort Lauderdale (FL); On-site; USD 120,000 - 180,000; Full time

Job summary

GBI Bio in Fort Lauderdale, FL seeks a senior leader to manage the Quality Control Analytical team in a GMP-regulated environment. You will direct method qualification/validation and ensure timely transfer of analytical methods from Process Development.

You will oversee audits, regulatory inspections, and investigations, driving corrective actions and continuous improvement while mentoring staff and ensuring compliance with GMP/ICH standards.

Qualifications

• Bachelor in biological or biochemical sciences or related field.
• Must have at least five years of direct work experience in FDA regulated environment.
• Experience leading a QC Analytical team in a GMP/GLP environment is preferred.

Responsibilities

• Provide leadership and strategic direction for the QC Analytical Department.
• Ensure Analytical Services comply with GMP/GLP standards and guidelines.
• Lead design, development, and qualification/validation of analytical methods.
• Coordinate timely method transfers to QC from Process Development.
• Ensure testing and evaluation of products meet regulatory standards and timelines.
• Develop and manage stability program schedules and QC lab schedules.
• Generate/review Stability Protocols per ICH guidelines and create Summary Reports.
• Review and supervise input/output reports and SOPs; close exception documents on time.
• Coach and mentor junior staff; participate in client audits and regulatory inspections.
• Monitor notebooks for timely issuance, review, and archival.

Skills

Problem solving

Communication skills

GMP knowledge

Attention to detail

Leadership

Time management

Conflict resolution

Critical thinking

Prioritization

Diversity awareness

Education

Bachelor in biological or biochemical sciences

Job description

GBI Bio in Fort Lauderdale, FL seeks a senior leader to manage the Quality Control Analytical team in a GMP-regulated environment. You will direct method qualification/validation and ensure timely transfer of analytical methods from Process Development.

You will oversee audits, regulatory inspections, and investigations, driving corrective actions and continuous improvement while mentoring staff and ensuring compliance with GMP/ICH standards.