Manager, Quality Assurance

THE ROLE:

The Manager of Quality Assurance is responsible for managing Quality Assurance staff and activities at Winston Salem, NC. They are responsible for ensuring the Herbalife production, and products made at the facility including personalized vitamins, are managed in accordance with all applicable regulations and standards and meet all quality requirements.  In the event of any quality issues and/or non-conformances they will ensure the issues are appropriately investigated, documented and escalated as needed to Director, Quality Assurance.

HOW YOU WOULD CONTRIBUTE:  
•    Lead the operations of Quality Assurance, Quality Engineering and Document Control.
•    Serve as a subject matter expert in the interpretation and implementation of all applicable regulatory requirements and standards (e.g,. 21 CFR Parts 117, 114, 111, MUI Halal, Kosher, Non-GMO, Gluten-free, etc.)
•    Lead all aspects of quality documentation related to product batch records, deviations, and change controls.
•    Quality management of raw materials and components used in production of Herbalife products.
•    Ensuring facility is a state of GMP compliance with proper temperature, humidity and cleaning log maintenance.
•    Approve deviations and other quality-related documents requiring management review.
•    Ensure all problem reports and nonconformance reports undergo detailed investigation and are closed.  
•    Ensure the CAPA and SCAR program is appropriately run.
•    Prepare and provide updates to senior leadership.
•    Mentor, train and develop staff.
•    Perform other related duties as assigned by management. 
•    Train personnel on compliance-related topics and procedures as needed.
•    Write and revise compliance-related procedures and forms (e.g., SOPs, forms, food safety plans)
•    Ensure site has appropriately trained PCQIs (Preventive Controls Qualified Individual) for FSMA.
•    Ensure food safety plans are composed and maintained for all relevant product types.
•    Ensure review, monitoring and verification activities are performed for all food safety plans.
•    Evaluate changes to facilities, materials, products and equipment for impact on compliance.
•    Work with regional GRA to ensure compliance-related documents (e.g., certificates of manufacture, import documents, etc.) are provided in a timely manner.
•    Monitor and maintain KPI performance.
•    Perform the Quality review of SKUs, Formulas, FSFs, Labels and Deviations as needed.
•    Perform the QA functions of the stability program including evaluating testing data, assigning shelf-life and signing final reports or forms as needed.

SUPERVISORY RESPONSIBILITIES:
•    Quality Assurance, Quality Engineering and Document Control staff.

 

  #LI-TK1!

 

 

SKILLS AND BACKGROUND REQUIRED TO BE SUCCESSFUL: 
•    7+ years working for a food, supplement or cosmetic company
•    5+ years manufacturing operation experience
•    Extensive knowledge of GMPs, FDA regulations and documentation procedures
•    Demonstrated ability to lead and manage QA functions and programs
•    Ability to communicate cross functionally with peers, associates and upper level management
•    Excellent written and verbal communication skills
•    Ability to work independently as well as in a team environment
•    Coaching and mentoring skills - team development
•    Compliance auditing experience and training skills
•    cGMP proficiency
•    Proficiency in Microsoft Office applications, including Word and PowerPoint

Education
•     Bachelor's Degree in Food Science, Nutrition, Chemistry or related

Herbalife offers a variety of benefits to eligible employees in the U.S. (limited to the 50 States and the District of Columbia), which includes Group Health Programs, other Voluntary Benefit Programs, and Paid Time Off. Group Health Programs include Medical, Dental, Vision, Health Savings Account (HSA), Flexible Spending Accounts (FSA), Basic Life/AD&D; Short-Term and Long-Term Disability, and an Employee Assistance Program (EAP). Other Voluntary Benefit Programs include a 401(k) plan, Wellness Incentive Program, Employee Stock Purchase Plan (ESPP), Supplemental Life/Critical Illness/Hospitalization/Accident Insurance, and Pet Insurance. Paid time off includes Company-observed U.S. Holidays, Floating Holidays, Vacation, Sick Time, a Volunteer Program, Paid Maternity and Paternity Leave, Bereavement Leave, Personal Leave and time off for voting.