QC LCM/Stability Lead
Laboratoire Guerbet
Summary
The QC LCM/Stability Lead will be operating in full compliance with applicable hygiene, safety, quality, and regulatory standards, and in alignment with the organization's framework, company's procedures, and the defined scope of responsibility the role is accountable for.
Job description
The LCM / Validation & Stability Chemistry Lead is responsible for providing technical leadership and oversight of analytical method validation and stability programs to ensure product quality and regulatory compliance. This role serves as a Subject Matter Expert (SME) supporting regulatory inspections, lifecycle management, and cross-functional initiatives in a cGMP-regulated environment.
Your Role
- Leads and owns the analytical method validation strategy across products, ensuring alignment with regulatory expectations and business objectives
- Serves as Subject Matter Expert (SME) during regulatory inspections and audits (FDA, EMA), including preparation, defense of methodologies, and response to observations
- Provides technical leadership, coaching, and mentorship to junior analysts and scientists, fostering development and compliance culture
- Reviews, approves, and ensures the scientific integrity of validation protocols, reports, and associated documentation
- Designs, authors, and oversees execution of analytical method validation and verification protocols, including accuracy, precision, specificity, linearity, range, and robustness assessments
- Interprets and approves validation data, ensuring compliance with data integrity (ALCOA+) principles and regulatory requirements
- Establishes and enforces standards for identification, documentation, and escalation of deviations, OOS, OOT, or atypical results
- Leads complex investigations into method-related quality issues, drives root cause analysis, and ensures implementation of appropriate corrective and preventive actions (CAPA)
- Owns analytical method lifecycle management, including method transfer, continuous improvement, periodic review, and change control assessment
- Ensures laboratory systems, instrumentation, and processes supporting method validation are compliant, qualified, calibrated, and audit-ready
- Drives compliance with cGMP, ICH (Q2, Q14 as applicable), and global regulatory expectations, always ensuring inspection readiness
- Partners cross-functionally with QA, Regulatory Affairs, Manufacturing, and R&D to support product development, regulatory submissions, and commercial lifecycle activities
Your Background
Required Qualifications
- Bachelor's degree in Chemistry or related scientific field with 10+ years of experience, or Master's degree with 5+ years of experience, or PhD with 2+ years of experience
- Extensive experience in analytical method validation within a cGMP-regulated pharmaceutical environment
- Strong knowledge of regulatory expectations and guidelines (cGMP, ICH Q2, Q1A, USP requirements)
- Experience with analytical techniques (e.g., HPLC, GC, dissolution, spectroscopy)
- Experience with laboratory systems (e.g., LIMS, Empower, CDS) and understanding of data integrity principles (ALCOA+)
- Strong problem-solving skills and ability to make sound technical decisions
- Excellent written and verbal communication skills with the ability to work with cross-functional teams
Preferred Qualifications
- Proven experience leading validation activities, investigations, and lifecycle management
- Advanced knowledge of evolving guidelines (e.g., ICH Q14)
- Advanced or specialized expertise in analytical techniques
- Demonstrated leadership capabilities (mentoring, project ownership, team influence)
- Experience interfacing directly with regulatory agencies
Requirements
- Bachelor's degree in Chemistry or related scientific field with 10+ years of experience, or Master's degree with 5+ years of experience, or PhD with 2+ years of experience
- Extensive experience in analytical method validation within a cGMP-regulated pharmaceutical environment
- Strong knowledge of regulatory expectations and guidelines (cGMP, ICH Q2, Q1A, USP requirements)
- Experience with analytical techniques (e.g., HPLC, GC, dissolution, spectroscopy)
- Experience with laboratory systems (e.g., LIMS, Empower, CDS) and understanding of data integrity principles (ALCOA+)
- Strong problem-solving skills and ability to make sound technical decisions
- Excellent written and verbal communication skills with the ability to work with cross-functional teams
- Proven experience leading validation activities, investigations, and lifecycle management
- Advanced knowledge of evolving guidelines (e.g., ICH Q14)
- Advanced or specialized expertise in analytical techniques
- Demonstrated leadership capabilities (mentoring, project ownership, team influence)
- Experience interfacing directly with regulatory agencies
Company overview
Laboratoire Guerbet, also known as Guerbet Group, is a pioneering French pharmaceutical company that has been at the forefront of medical imaging since its official establishment in 1926. The company traces its origins to 1901 when Marcel Guerbet discovered the world's first iodinated contrast medium, Lipiodol. Today, Guerbet specializes in developing and manufacturing contrast media, injection systems, medical devices, and digital solutions for diagnostic and interventional imaging. With a workforce of over 2,900 employees globally, the company operates manufacturing facilities across France, Brazil, Ireland, and the United States. Guerbet's comprehensive product portfolio includes MRI contrast agents like Dotarem and Elucirem, X-ray contrast media, and specialized solutions for interventional radiology. The company has achieved global leadership in medical imaging, ranking among the world's top three players in the sector following its strategic acquisition of Mallinckrodt's contrast media business in 2015. Guerbet continues to innovate through investments in digital technologies and artificial intelligence, aiming to improve radiologist productivity and enhance tumor characterization for better treatment guidance.