Manager, Validation

Overview

POSITION SUMMARY STATEMENT: 

 

The Validation Manager is responsible for all equipment, utilities and facilities validation/qualification activities at the Herbalife Innovation and Manufacturing facility in Winston-Salem, NC. This individual will lead all projects required for the startup, expansion and improvement of operations at the HIM-WS facility.

 

DETAILED RESPONSIBILITIES/DUTIES:  

•    Develop and maintain Validation Master Plan in support of cGMP requirements and company objectives.•    Plan, schedule, direct, evaluate, and lead the work assignments to meet the department goals in terms of quality, productivity and efficiency. Develop, implement and maintain resource planning tools in order to project staffing needs and manage cost.•    Perform and/or review quality investigations and customer processes for CAPAs, Quality Events, Complaints, and Deviations that are related to validations. Review reports to ensure root cause analysis was performed using Quality Tools (e.g. Ishikawa Diagram, 5 Why’s, DMAIC, etc.).•    Perform or assist with preparation for FDA and other regulatory agency audits, inspections and customer audits.•    Perform or assist in internal audits and external audits. Write internal audit reports and follow up on completion of any open corrections or corrective actions deemed vital that were communicated and documented to the auditee.•    Ensure adequacy of validation procedures for cGMP compliance and to meet other regulatory/3rd party certification requirements.•    Ensure stakeholders and management are advised and actions are taken to address the quality problem(s) in a timely manner.•    Conduct validation workshops and provide site-wide validation training as needed.•    Create validation protocols and summary reports in compliance with Herbalife Nutrition standards. •    Review change requests for facility modification, new equipment and document approvals. •    Implement innovation ideas and continuous improvement activities to support department goals.•    Perform other duties as assigned

Qualifications

REQUIRED QUALIFICATIONS: 

 

Skills: 

•    Strong understanding of validation lifecycle management.•    Knowledge and proven track record working with risk management methodologies and tools.•    Demonstrated ability to plan and prioritize projects.•    Excellent written and oral communication skills.•    Strong interpersonal, problem-solving, and analytical skills.•    Proven track record to lead and thrive in the matrix management structure.•    Demonstrated strong results orientation and proven ability to consistently meet and/or exceed goals. •    Strong knowledge of cGMP•    Proficient in Microsoft Office Suite, including MS Project and Visio 

 

Experience:

 

•    7 years’ experience with validation/qualification in a GMP environment.

 

Education:

•    Bachelor degree in Chemistry, Engineering or scientific related field. PREFERRED QUALIFICATIONS: 

•    Innovative approach to problem-solving and integrated view of business/scientific issues•    Experience with Lean Manufacturing and Continuous Improvement concepts•    Knowledge of qualification requirements for powder and liquid handling, processing, and packaging •    Knowledge of ISO17025 standards•    Proficient in ValGenesis

 

 

 

 

 

 

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US Benefits Statement

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.