QC LCM/Stability Lead

Guerbet; Raleigh (NC); On-site; USD 100,000 - 150,000; Full time

Job summary

Guerbet, a global leader in medical imaging, seeks a QC LCM/Stability Lead in Raleigh, NC to supervise analytical method validation and stability programs within a cGMP framework.

You will act as SME during regulatory inspections, guide lifecycle management of methods, and ensure data integrity while driving cross-functional collaboration across QA, Regulatory Affairs, and Manufacturing.

Qualifications

• Bachelor’s degree in Chemistry or related field; 10+ years experience, or Master’s with 5+ years, or PhD with 2+ years.
• Extensive analytical method validation experience in a cGMP-pharma environment.
• Strong knowledge of regulatory expectations (cGMP, ICH Q2, Q1A, USP).
• Experience with analytical techniques (HPLC, GC, dissolution, spectroscopy).
• Familiarity with laboratory systems (LIMS, Empower, CDS) and data integrity (ALCOA+).
• Excellent written and verbal communication; ability to work cross-functionally.

Responsibilities

• Lead the analytical method validation strategy across products with regulatory alignment.
• Serve as SME during FDA/EMA inspections and audits, including defense of methodologies.
• Provide technical leadership, coaching, and mentorship to junior staff.
• Review and approve validation protocols, reports, and documentation.
• Design and oversee validation/verification protocols (accuracy, precision, specificity, linearity, range, robustness).
• Interpret validation data ensuring ALCOA+ data integrity.
• Set standards for deviations, OOS, OOT, and atypical results and escalation.
• Lead investigations into method-related quality issues and CAPA implementations.
• Own lifecycle management of analytical methods including transfers and changes.
• Ensure laboratory systems and processes are compliant, qualified, calibrated, and audit-ready.
• Drive cGMP compliance and regulatory readiness with global expectations.

Skills

Problem solving

Cross-functional collaboration

Communication skills

Analytical thinking

Education

Bachelor’s degree in Chemistry or related field

Master’s degree in Chemistry or related field

PhD in Chemistry or related field

Tools

HPLC

GC

Dissolution

Spectroscopy

LIMS

Empower

CDS

Job description

At Guerbet, we build lasting relationships so that to enable people to live better. This is Our Purpose.

We are a global leader in medical imaging, offering an extensive portfolio of pharmaceuticals, medical devices, digital and AI solutions, for diagnostic and interventional imaging. As a pioneer in the field of contrast products since the last 95 years ,we continuously innovate. We dedicate 10% of our revenue to Research & Development such as to improve the diagnosis, prognosis and quality of life of patients.

Achieve, Cooperate, Care and Innovate are the values that we share and practice on a daily basis.

Working at Guerbet is not only being part of a multicultural team of 2,600 people across more than 20 countries, but, it is above all about playing a unique role in the future of medical imaging.

For more information on Guerbet, go to www.guerbet.com and follow Guerbet on Linkedin, Twitter, Instagram and Youtube

WHAT WE ARE LOOKING FOR

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.

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

Reason to join US

Much 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.

Guerbet is an Equal Opportunity Employer. As an organization, we believe that no individual should be discriminated against because of their differences, which includes the following: age, disability, ethnicity, gender, gender identity and expression, religion, or sexual orientation. All employment decisions shall be made without regard to age, race, creed, color, religion, sex, national origin, ancestry, disability status, veteran status, sexual orientation, gender identity or expression, genetic information, marital status, citizenship status, or any other basis as protected by federal, state, or local law. Guerbet is committed to diversity, equity, and inclusion.

Guerbet provides accommodations to applicants and employees with disabilities. If you need an accommodation to apply for a position please send an email to [e-mail] or you can also call this number+19843443717