Manager, Quality Compliance Auditor

THE ROLE:

 

 

 

HOW YOU WOULD CONTRIBUTE:  
•    Manage the Corporate Compliance QMS audit program (e.g., plan, schedule and execute all audit activities including creation and dissemination of audit summary reports)
•    Participate in due diligence audits for onboarding new Contract Manufacturer, Laboratories and Suppliers by handling audits, new product startups, investigations, corrective and preventive actions (CAPAs), communication and other issues as they arise. 
•    Serve as a subject matter expert in the interpretation and implementation of all applicable regulatory requirements (e.g., 21 CFR Parts 117, 114, 111, 11, NSF, ISO, Halal, Kosher, Non-GMO, etc.)
•    Manage and/or oversee all compliance-related programs
•    Communicate and/or interact with compliance experts and consultants as required
•    Train company personnel on compliance-related topics and procedures
•    Write and revise compliance-related procedures and forms
•    Provide assistance before, during and after all regulatory inspections
•    Ensure sites have a PCQI (Preventive Controls Qualified Individual) for FSMA, food safety plans are maintained, and have a site coordinator for HACCP
•    Evaluate regulatory changes to facilities, QC laboratories, materials, products and equipment for to Herbalife and supporting functions.
•    Ensure all applicable facility registrations and applicable testing i.e., NSF, ISO, etc. are being maintained
•    Perform additional duties as assigned.

SUPERVISORY RESPONSIBILITIES:
•    None

SKILLS AND BACKGROUND REQUIRED TO BE SUCCESSFUL: 
•    7+ years of experience working in the globally regulated industry, preferably in food or dietary supplement industry and in quality or compliance-related roles
•    Required 3+ years of auditing experience in FDA-regulated industry
•    Working knowledge of QMS, GMPs, GLP’s, FDA regulations and industry requirements and certifications for food and dietary supplements globally
•    Understanding of the cGMP/GLP manufacturing and laboratory environment and basic production operation
•    The ability to effectively communicate both verbally and in writing with demonstrated management influence
•    Comfortable in small group and large group settings.
•    Must be detail oriented, take initiative to work on tasks independently and be able to work in a fast-paced environment to complete time sensitive projects or tasks.
•    Strong project management skills
•    Ability to develop positive relationships and work in a cross-functional team.
•    Compliance auditing experience and training skills
•    Proficiency in Microsoft Office applications, including Word and PowerPoint

•    Ability to travel (typically 60-75%, depending on business needs).

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

 

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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.