QC LCM / Stability Lead

Kelly Science, Engineering, Technology & Telecom; Raleigh (NC); On-site; USD 120,000 - 160,000; Full time

Job summary

Unknown QC team is seeking a QC LCM / Stability Lead to provide technical leadership for analytical method validation, stability programs, and analytical lifecycle management in a cGMP pharmaceutical environment.

The role serves as SME for validation strategy, stability studies, regulatory compliance, and inspection readiness while leading scientists and collaborating with cross-functional teams to support commercial products and lifecycle activities.

Qualifications

• Bachelor's degree with 10+ years of pharmaceutical analytical laboratory experience, or Master's with 5+ years, or PhD with 2+ years.
• Extensive experience with analytical method validation in a cGMP pharmaceutical environment.
• Strong knowledge of ICH guidelines (Q2, Q1A), USP requirements, and cGMP regulations.
• Experience with HPLC, GC, dissolution, spectroscopy, and other analytical techniques.
• Experience with Empower, LIMS, or other chromatography data systems.
• Strong troubleshooting, investigation, and root cause analysis skills.
• Excellent written, verbal, and cross-functional communication skills.

Responsibilities

• Lead analytical method validation, verification, transfer, and lifecycle management activities.
• Develop and oversee validation strategies in alignment with cGMP, ICH, USP, and regulatory expectations.
• Review and approve validation protocols, reports, and technical documentation.
• Serve as SME during FDA and other regulatory inspections and customer audits.
• Lead investigations involving OOS, OOT, deviations, and method-related quality issues, including root cause analysis and CAPA implementation.
• Oversee stability programs and ensure compliance with stability protocols and reporting requirements.
• Drive continuous improvement initiatives for analytical methods, laboratory processes, and validation programs.
• Ensure laboratory instrumentation, systems, and documentation remain qualified, compliant, and audit ready.
• Partner with Quality, Regulatory Affairs, Manufacturing, and R&D to support product development, submissions, and commercial operations.
• Mentor and develop scientists and analysts while promoting a strong quality and compliance culture.
• Maintain compliance with cGMP, ALCOA+ data integrity principles, and global regulatory requirements.

Skills

cGMP Compliance

Analytical Method Validation

Regulatory Inspections

Data Integrity (ALCOA+)

Leadership & Mentoring

Cross-functional Collaboration

Education

Bachelor's degree in Chemistry or related

Master's degree in Chemistry or related

PhD in Chemistry or related

Tools

Empower

LIMS

Job description

Schedule: Fully onsite, Monday–Friday, normal business hours

Position Summary

The QC LCM / Stability Lead provides technical leadership for analytical method validation, stability programs, and analytical lifecycle management in a cGMP-regulated pharmaceutical environment. This role serves as the subject matter expert (SME) for validation strategy, stability studies, regulatory compliance, and inspection readiness while leading scientists and partnering with cross-functional teams to support commercial products and product lifecycle activities.

Key Responsibilities

• Lead analytical method validation, verification, transfer, and lifecycle management activities.
• Develop and oversee validation strategies in alignment with cGMP, ICH, USP, and regulatory expectations.
• Review and approve validation protocols, reports, and technical documentation.
• Serve as SME during FDA and other regulatory inspections and customer audits.
• Lead investigations involving OOS, OOT, deviations, and method-related quality issues, including root cause analysis and CAPA implementation.
• Oversee stability programs and ensure compliance with stability protocols and reporting requirements.
• Drive continuous improvement initiatives for analytical methods, laboratory processes, and validation programs.
• Ensure laboratory instrumentation, systems, and documentation remain qualified, compliant, and audit ready.
• Partner with Quality, Regulatory Affairs, Manufacturing, and R&D to support product development, submissions, and commercial operations.
• Mentor and develop scientists and analysts while promoting a strong quality and compliance culture.
• Maintain compliance with cGMP, ALCOA+ data integrity principles, and global regulatory requirements.

Qualifications

Required

• Bachelor's degree in Chemistry or related scientific discipline with 10+ years of pharmaceutical analytical laboratory experience, or
• Master's degree with 5+ years of experience, or
• PhD with 2+ years of experience.
• Extensive experience with analytical method validation in a cGMP pharmaceutical environment.
• Strong knowledge of ICH guidelines (Q2, Q1A), USP requirements, and cGMP regulations.
• Experience with HPLC, GC, dissolution, spectroscopy, and other analytical techniques.
• Experience with laboratory systems such as Empower, LIMS, or other chromatography data systems.
• Strong technical troubleshooting, investigation, and root cause analysis skills.
• Excellent written, verbal, and cross-functional communication skills.

Preferred

• Experience leading validation programs, analytical lifecycle management, and stability studies.
• Knowledge of ICH Q14 and modern analytical lifecycle management principles.
• Experience supporting regulatory inspections and responding to agency observations.
• Previous leadership, mentoring, or people management experience.
• Laboratory-based role in a cGMP pharmaceutical manufacturing environment.
• Combination of laboratory work, data analysis, and technical documentation.
• Requires use of PPE and adherence to GMP and safety procedures.
• Occasional schedule flexibility may be required to support projects, investigations, or inspections.

Leadership This role reports to the QC Chemistry Manager and provides direct leadership to QC scientists and analysts supporting analytical method validation, lifecycle management, and stability programs. It is responsible for technical oversight, team development, and ensuring laboratory compliance and operational excellence.