Sr. Supervisor, Manufacturing Quality Compliance

Overview

POSITION SUMMARY STATEMENT: 

The Sr. Supervisor, Quality Compliance is responsible for leading Quality Compliance and Document Control staff and activities. They are responsible for ensuring the facility and its many quality and document control programs are managed in accordance with all applicable regulations and standards. The Sr. Supervisor will take the lead on preparing for, hosting, and responding to all compliance audits and will lead the internal audit program to ensure compliance is maintained in all areas of the operation. The Sr. Supervisor is responsible for all Document Control activities related to master records, production batch records, blend and product release, document change requests, document archival, SOP updates, GDP training and logbook control, and tracking/trending aged and unreleased materials.

DETAILED RESPONSIBILITIES/DUTIES:  
•    Supervise the operations of the Quality Compliance and Document Control teams
•    Monitor and maintain KPI performance
•    Maintain the Document Change Control Program
•    Maintain information for all controlled documents
•    Assess and continually improve the effectiveness of compliance-related training
•    Train personnel on compliance-related topics and procedures as needed
•    Reviews and approves Master Manufacturing Records (MMRs), Reprocessing Approvals, Planned Deviations, Document Change Requests, Change Control Requests, LIMS templates.
•    Develop compliance-related training materials in conjunction with the training department
•    Ensure quality documents and changes to quality documents are processed in a timely manner
•    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 created 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
•    Maintain all applicable facility registrations
•    Oversee NSF certification program
•    Lead and oversee audit prep and audit response activities
•    Manage the internal audit, allergen control and gluten-free programs
•    Work with regional GRA to ensure compliance-related documents (e.g., certificates of manufacture, import documents, etc.) are provided in a timely manner
•    Ensure SOPs for all Quality Compliance and Document Control programs are kept up to date and accurate
•    Identify and test improvements to daily work tasks, present viable improvements to management for adoption
•    Identify and standardize events that don't have a standard process; provide direction, make decisions 
•    Implement management objectives; monitor and maintain successful KPI performance
•    Work closely with other QA supervisors to ensure good alignment, communication, and cooperation
•    Support and implement visual management tools
•    Prepare and provide updates to senior QA leadership
•    Coach, train and develop staff and manage performance as needed
•    Communicate and/or interact with compliance experts and consultants as required
•    Performs other related duties as assigned by management. 

SUPERVISORY RESPONSIBILITIES:

Supervises 
•    Sr. QA Document Control Coordinators
•    QA Document Control Coordinators
•    Quality Compliance staff 
 

Qualifications

REQUIRED QUALIFICATIONS:

Skills:

• Extensive knowledge of GMPs, FDA regulations and documentation procedures
• Demonstrated ability to lead and manage QA and Compliance functions and programs
• Ability to communicate cross functionally with peers, associates and upper-level management

• Manufacturing experience in a multi-shift facility

Experience:

• A minimum of 7 years of experience working in FDA-regulated industry, preferably in food or dietary supplement industry and in quality or compliance-related roles
• 2  years of supervisory experience in a quality/regulatory environment will be considered in lieu of a degree

Education:

• BA/BS degree or relevant work experience

PREFERRED QUALIFICATIONS:

• • BA/BS degree in a Chemistry, Biology, or other Scientific related field of study from an accredited institution.
  • 7 years’ experience in a Quality role in a Dietary Supplement or Acidified Food company
  • ASQ Certified in the areas of Inspection, Auditing, Engineering or Managing Quality

  #LI-TK1

At Herbalife, we value doing what’s right. We are proud to be an equal opportunity employer, making decisions without regard to race, color, religion, sex, sexual orientation, gender identity, marital status, national origin, age, veteran status, disability, or any other protected characteristic. We value diversity, strive for inclusivity, and believe the differences among our teammates is a key contributor to Herbalife’s ongoing success.

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.

If reasonable accommodation is needed to participate in the job application or interview process, to perform essential job functions, and/or to receive other benefits and privileges of employment, please email your request to [email protected]