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H
Herbalife
Manager, Stability
Career Insights for Director of Quality Assurance
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Based on California data
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What they do
A Director of Quality Assurance oversees and directs the overall operations of quality assurance within a company to ensure continuous improvement and compliance.
$169,784 / year median in California
-1% projected decline
Job Description
Overview
ROLE AT A GLANCE
The Stability Manager leads the execution, coordination, and continuous improvement of the stability program for Dietary Supplement, Food, and Personal Care products. This role serves as a key technical and communication hub, ensuring stability data is scientifically sound, compliant, delivered on time, and clearly communicated to project teams to support product development, registration, and lifecycle management across regions.HOW YOU'LL MAKE AN IMPACT
- Lead and oversee stability studies, including protocol execution, sample management, data review, statistical analysis, trending, and reporting.
- Serve as a primary communication lead for stability, proactively updating project teams, QC managers, R D, Regulatory, and regional stakeholders on study status, milestones, risks, and outcomes.
- Ensure stability timelines are met by actively tracking deadlines, stability pull schedules, testing completion, and reporting deliverables using LIMS and project management tools.
- Coordinate and support new product stability programs, ensuring timely shelf‑life assignment critical for global product registration and market readiness.
- Apply statistical analysis and trending techniques to stability data to support shelf life determination, identify emerging risks, and drive data based decisions, and provide technical review and approval of stability protocols, acceptance criteria, and reports prior to cross functional or regional use
- Lead and coordinate the resolution of stability‑related OOS, deviations, and adverse trends, collaborating with QC, QA, and scientific teams to determine root cause and corrective actions.
- Maintain strong alignment with QC managers, analytical teams, and R D partners by leveraging knowledge of analytical methods to support data interpretation, investigations, formulation development, specification setting, and interpretation of stability results for new and reformulated products.
- Ensure compliance with
FDA 21 CFR
Part 111, ISO/IEC 17025, cGMP, GDP, and applicable ICH stability guidelines.- Identify industry best practices and implement continuous improvement initiatives to enhance stability processes, tools, templates, and efficiency.
- Additional duties as assigned.
TEAM DYNAMICS
- This role leads Technicians, Stability Coordinators and/or Senior Stability Coordinators and works closely with QC managers, scientists, R D, Regulatory, Licensing, and regional partners.
LEADERSHIP AND SUPERVISORY RESPONSIBILITIES
- Directly manages Technicians, Stability Coordinators and/or Senior Stability Coordinators.
- Responsible for onboarding, training, performance management, coaching, and development of stability team members.
- Supports workload planning and readiness as stability oversight expands across regions or sites.
QUALIFICATIONS FOR SUCCESS
Education- Bachelor of Science degree in Chemistry, Biochemistry, Biology, Microbiology, or a related scientific discipline. Experience
- 7+ years
- Demonstrated experience with stability protocol oversight, data interpretation, statistical trending, and shelf life assignment for regulated products.
- Strong working knowledge of
FDA 21 CFR
Part 111, ISO/IEC 17025, cGMP, GDP, and ICH stability guidelines applicable to food and dietary supplements.- Experience resolving OOS, deviations, and stability related investigations in collaboration with QC and QA.
Skills/Certifications:
- Advanced understanding of stability science, regulatory expectations, and industry best practices.
- Strong communication and stakeholder alignment skills, with the ability to clearly convey technical stability data to diverse audiences.
- Proficiency in statistical analysis and data trending for stability and shelf life determination.
- Preferred familiarity with analytical methods used in QC testing (e.g., HPLC, ICP, GC) to support data interpretation.
- Experience using Laboratory Information Management Systems (LIMS), preferably LabWare.