QC LCM/Stability LeadWHAT WE ARE LOOKING FORThe 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.
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 BACKGROUNDRequired 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
Reason to join USMuch more than a Competitive salary,We offer continued personal development. When you join Guerbet, you : - Are choosing a global leader with recognized expertise in diagnostic and interventional imaging,
- Are joining our 2820 collaborators who are committed every day to offering innovative solutions to improve quality of patient's life all over the world,
- Are joining a company where we value diversity of talents coming from various horizon.
We # Innovate # Cooperate # Care #Achieve at Guerbet.
