Director, QC Analytics & Technology — Lead Excellence

BioTalent; Tustin (CA); On-site; USD 163,000 - 204,000; Full time

Job summary

BioTalent is seeking a Director, Quality Control Analytical Sciences & Technology to lead analytical strategy and provide scientific oversight for QC operations supporting clinical and commercial biopharmaceutical manufacturing.

You will drive lifecycle management of GMP analytical methods, oversee investigations, and champion continuous improvement while leading a high-performing team and partnering with QA, Regulatory, and clients.

Qualifications

• B.S. in Chemistry, Biochemistry, Biology or related field; M.S. or higher preferred.
• Minimum 10 years of industry experience in a QC or analytical laboratory.
• Experience with GMP environments, analytical testing, reports, procedures and regulatory audits.

Responsibilities

• Lead the lifecycle management and governance of GMP analytical methods to ensure they remain fit-for-purpose and compliant throughout their lifecycle.
• Serve as the scientific leader for complex OOS, OOT, deviation, atypical result, and recurring invalid assay investigations.
• Drive root cause investigations, CAPAs, risk mitigation, and analytical continuous improvement initiatives.
• Oversee analytical performance monitoring programs, statistical trending, dashboards, and management reviews.
• Establish and maintain analytical control strategies, method governance processes, and performance metrics.
• Lead and develop the Analytical Sciences & Technology team with resource planning and succession planning.
• Partner with QC Operations, Analytical Development, MS&T, QA, Regulatory Affairs, and clients on strategy and issue resolution.
• Serve as the analytical SME during audits, inspections, regulatory submissions, client interactions, and strategic initiatives.

Skills

Quality Control

Analytical Sciences & Technology

Analytical Testing

Laboratory Instrumentation

GMP Compliance

OOS/OOT Investigations

Deviation Management

Method Lifecycle Management

Statistical Trending

Regulatory Compliance

FDA GuidelinesUSP

EP

EU Annexes

ICH Guidelines

Education

Bachelor's in Chemistry/Biochemistry/Biology

MS or higher preferred

Tools

Analytical Instruments

Laboratory Automation

Job description

BioTalent is seeking a Director, Quality Control Analytical Sciences & Technology to lead analytical strategy and provide scientific oversight for QC operations supporting clinical and commercial biopharmaceutical manufacturing.

You will drive lifecycle management of GMP analytical methods, oversee investigations, and champion continuous improvement while leading a high-performing team and partnering with QA, Regulatory, and clients.