Herbalife Winston Salem , NC 27108
Herbalife is a global nutrition company that has helped people pursue a healthy, active life since 1980. Our nutrition, weight-management and personal care products are available exclusively through dedicated independent members in more than 90 countries. Our Mission is to change people's lives by providing the best business opportunity in direct selling and the best nutrition and weight-management products in the world.
POSITION SUMMARY STATEMENT:
The Director of QC Compliance & Accreditation is responsible for managing the global implementation of the QC policies and accreditation programs (ISO17025). Assures systems and all Herbalife laboratories are in compliance with cGMP and current regulations.
Oversee Quality Control global audit program (GMP and ISO17025) including managing audit schedules, CAPA (corrective action(s)/preventive action(s)) tracking and development, and managing project related activities.
Lead laboratory's audit preparation activities, accompanies inspectors, and completes reports.
Conduct internal audits and manages the status of on-going quality improvement programs.
Lead 3rd party Certification/Accreditation for all of Herbalife labs 3rd Party labs.
Develop QC Compliance & Accreditation Master Plan for quality initiatives that clearly define scope, assumptions, risks and implementation plan including resource needs, timeline and communication structure.
Develop and maintain all policies and procedures of the QC Compliance & Accreditation Program.
Ensure that all procedures and activities performed within the distribution centers are cGMP compliant to 21 CFR Part 110 and Part 111.
Lead the development of innovative systems and controls to optimize laboratories while assuring compliance with company's quality standards
Oversee Post Market Surveillance testing program, including documenting and trending data/findings; work with cross-functional team to determine root cause and establish appropriate CAPAs.
Develop and maintain reports to inform stakeholders and management on quality trending by manufacturer/supplier, formula and SKUs.
Assist in the identification and achievement of Herbalife Quality KPI's through appropriate CAPA and continuous improvement initiatives.
Develop training plan for QC Compliance and Accreditation team.
Develop and maintain a system that assures all certificates of analyses are reviewed against required finished product specifications as written in Agile PLM (Product Lifecycle Management).
Perform and assist in investigations to identify root cause and support CAPA implementation as needed.
Prepare monthly reports as needed.
Knowledge of cGMP's
Knowledge of ISO17025
Knowledge of 21 CFR Part 110/111
Knowledge of Pharmacopoeias (US, Ph.Eur, China)
Knowledge of ICH guidelines
10 years in a FDA-regulated industry
Validation of analytical methods
Knowledge of Quality Systems
Experience in Quality by Design
Expert knowledge in CAPA, deviation handling & non-conformance
Advanced degree in Chemistry, life sciences or other technical field