Senior Director, Quality Operations in Greenville, SC at Volt

Date Posted: 6/9/2020

Job Snapshot

  • Employee Type:
    Direct Hire
  • Job Type:
  • Duration:
    N/A
  • Date Posted:
    6/9/2020
  • Job ID:
    232744
  • Pay Rate
    $200000.0/Hour
  • Contact Name
    Volt Branch
  • Phone
    (407) 862-0090

Job Description



Overview

We are looking for a Sr. Director, Quality Operations. This role ensures that the manufacturing operations comply with  FDA, State, Corporate and sites requirements. Support SVP, Quality & RA in setting the direction to all facilities. The role reports to our SVP Quality and Regulatory.



Responsibilities

  • Direct and monitor quality programs and systems for all sites to ensure all products consistently meet or exceed expectations, and that all related regulatory requirements are met.
  • Direct and manages Quality Control, Quality Assurance and Quality Engineering for all facilities.
    • Responsible for Interviewing, hiring and coach directs reports
    • Responsible for training, performance reviews and recommending developmental activities of directs reports
    • Provides for safety and security of the work place.
  • Develops consistent quality control and compliance programs throughout all operations.
  • Ensures that the facilities quality system is established and maintained in compliance with applicable local? ordinances, State statutes and federal regulations, and other laws, including but not limited to Title 21 CFR 111, 110, 117,210, 211, ISO9001.
  • Renders final decision for all actions affecting products or systems that are inherent in all quality operations.
  • Directs the continuing improvements for all functions within Quality Operations.
  • Sets direction for product quality improvements efforts
  • Develops all Quality operations budgets. Develops and maintains budgetary items that govern all facilities.
  • Oversees and requires action to any adverse quality metric or threshold.
  • Manages the quality engineering functions that are global to all facilities. Assist in additional QE functions where necessary.
  • Provides quality assistance and support to the Operations and Engineering departments in the areas of compliance, validation, facility changes and improvements.
  • Review new documents, as well as changes to existing documents, to assure  enhanced quality and productivity, while maintaining compliance with Corporate and regulatory requirements.
  • Other duties as assigned.



Qualifications

  • Bachelor’s Degree in a Scientific or Engineering discipline with exposure to Chemistry, Microbiology and Biology required. Master’s degree preferred.
  • Minimum 15 years of experience establishing and maintaining quality systems in the Dietary Supplements and/or Pharmaceutical manufacturing industry with 8+ years in a director role.
  • Strong knowledge of FDA Quality Systems regulatory requirements and of standards quality assurance practices for manufacturing operations such as 21 CFR 111, 110, 117,210, 211, ISO9001.
  • Aseptic filling and clean room experience is a must.
  • Experience in facilities integrations and harmonizations.
  • Professional Quality discipline certifications (CQMOE, CQE, CQA, RAC, Six Sigma) desired
  • Strong interpersonal skills – an instrument of change.
  • Will have 3-4 direct reports
  • Must have knowledge of FDA regulations 
  • Must be flexible, adaptable and able to change with the needs of the business 

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