QC LCM / Stability Lead
Location: Raleigh, NC
Salary: $98,000-$138,000/year
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.
Work Environment
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.
As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here (https://www.mykelly.com/help-support-working-with-kelly-us/#Benefits) for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.
Why Kelly ® Science & Clinical?
Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the world's most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goals-it's the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.
About Kelly
Work changes everything. And at Kelly, we're obsessed with where it can take you. To us, it's about more than simply accepting your next job opportunity. It's the fuel that powers every next step of your life. It's the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life-just ask the 300,000 people we employ each year.
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Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly's Human Resource Knowledge Center. Kelly complies with the requirements of California's state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.
