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External Quality Operations Director Job

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Primary Location: Greenville, SC

Job Tile: External Quality Operations Director

Job Number: 2017-48698

Date Posted: 4-20-2017

Job Summary:

The External Quality Operations Director will be integral in creating strategic direction for managing GNC Second Party Suppliers and Nutra Manufacturing’s Raw Material Supplier base. This individual will be responsible for managing the Quality Assurance and Quality Control due diligence across our entire supplier base. This includes setting standards for raw material specifications, finished dosage form specifications, finished product specifications, vendor questionnaires and so on. This individual will be responsible for developing a risk management based system to evaluate and assess each supplier so that appropriate levels of prevention and appraisal resources can be applied effectively to those suppliers that carry the highest risk of enforcement action.

This individual will be the Quality Management System representative for all 2nd Party product development projects. This individual will work with GNC Corporate Product Development and provide direct assistance to ensure Quality by Design elements are built into the product to support all claims made in labeling. This individual will oversee supplier development activities at various phases of the development process to ensure that commercialization and on-time launch objectives are met.

The External Quality Operations Director will be responsible for managing two Supplier Quality Engineers (SQE). This individual will be the Liaison that will represent GNC and Nutra’s Quality Management Vision to ensure that regulatory expectations and Standards of Evidence for documentation are consistently met. This individual will also leverage the personnel resources and testing capabilities of our vast network of second party and raw material suppliers.

This individual will be responsible for creating, and maintaining Supplier Quality Agreements and/or Continuing Product Guarantees to ensure that each supplier is aware of their obligations to GNC and Nutra.

This individual will be responsible for creation of and communication of metrics for the supplier quality program and for continuous improvement activities to enhance supplier compliance and continuous improvement. This individual must be able to interface with both internal and external stakeholders to ensure that expectations are being met and that there is balance between the strategic priorities of Quality, Cost and Speed to Market. This individual will also support the Quality team in various other quality related functions to include review of documents, participation in external audits, improvement teams, and leading/performing detailed root cause analysis when needed.

Essential Duties and Responsibilities:

STRATEGIC – THIS INDIVIDUAL DIRECTLY OVERSEES THESE STRATEGIC ACTIVITIES:

  • Oversees the Quality by Design activities to ensure that products that are developed by external 2nd Party suppliers meet all GNC expectations for Quality, Compliance and are not adulterated or misbranded. Responsible for the final approval of the product design against all established specification requirements.
  • Responsible for the final Material Use and Disposition for all GNC 2nd Party products that fail to meet a specification for Identity, Strength, Purity, Composition or Limits on Contaminants, including but not limited to Dietary Supplements, Conventional Food Forms, and so on.
  • Drives new ideas and innovation and develops strategies and tactics with respect to the Supplier Quality function to promote process improvements through the analysis and communication of quality metrics to key internal and external stakeholders, including raw material suppliers and 2nd Party manufacturers.
  • Facilitates implementation of robust quality assurance initiatives related to management review, risk assessment and reports
  • Manages the risk based supplier management and qualification program ensuring appropriate suppliers and 2nd Party manufacturers are audited and qualification occurs per procedure
  • Ownership of continuous quality improvement through management of GNC’s 2nd Party Contract Manufacturers, global external auditing and Quality Agreement management.
  • Provides leadership, development, coaching, mentoring and support for direct reports; Responsible and accountable for hiring and performance management of direct reports; Anticipates and plans for human resource needs
  • Quality Agreements are created and reviewed with Nutra/GNC Contract Manufacturers.

TACTICAL – DIRECTS THE ACTIVITIES OF SUPPLIER QUALITY MANAGEMENT STAFF TO ENSURE:

  • Preparation of and execution of annual audit plans are completed as assigned; Provides regulatory oversight to supplier base to ensure that non-conformities and corrective and preventative actions are robust and will meet the spirit of the regulations; Corrective actions and feedback have been provided where appropriate.
  • Adherence to departmental budget is maintained and Financial performance goals are met.
  • Strategic assessments (i.e., gap analysis) of quality metrics and compliance needs are conducted as required.
  • The authorization, revisions to and maintenance and administration of departmental control documents (i.e., SOPs, etc.) have been completed as necessary.
  • Performance reviews are conducted; Growth plans are developed; Employee-related policies, procedures and programs are interpreted, implemented and supported; Projects and tasks are assigned appropriately to staff based on prioritization scheme to align with business needs.
  • Procurement and Manufacturing are supported to ensure that raw materials meet standards of Identity, Strength, Purity, Composition and Limits on Contaminants. Product Development is supported through Quality by Design efforts to ensure that product launch and lifecycle are managed to meet business needs.
  • All supplier quality tasks are performed as required by GNC and Nutra procedures.
  • Supplier quality scorecard program is developed, maintained and aligned with Procurement Supplier Scorecard system.
  • Efforts are being lead in identifying, communicating, and resolving supplier quality problems; Supplier corrective and preventative action plans are developed and activities monitored as necessary.

Job Specifications:

  • Ability to function effectively at both strategic and tactical levels as a high profile representative of GNC and Nutra.
  • Proven leadership skills including the ability to coach, assess, evaluate, develop, motivate, and empower others.
  • Strong change management skills to challenge the status quo and drive improvements.
  • Models and supports organization’s goals and values.
  • Leadership by example, “roll up the shirtsleeves” management style and work ethic.
  • Lead and manage external resources, such as third party auditors acting on behalf of GNC and Nutra.
  • High personal ethical standards.
  • Manage, motivate, retain and develop technical professionals (exempt and non-exempt degreed professionals) and facilitate the development of a learning organization in which higher levels of execution such as analysis, synthesis and evaluation become second nature.
  • Ability to manage multiple projects and meet deadlines; self-motivation and goal oriented.
    • Good oral and written communication skills in order to communicate effectively with cross functional team members and management; Must be a team player and possess good interpersonal skills.
    • Required:

      · 20+ years quality related experience in a cGMP or regulated manufacturing industry with at least 10 years’ experience in Dietary Supplement GMPs across multiple dosage forms

      · 10+ years’ experience with International Regulatory Standards of the International Committee of Harmonization for Product Development, Quality Risk Management and Quality Management Systems as applied to different regulated industries

      · 5+ years of applying DSHEA and NLEA Labeling Regulations as codified in 21 CFR Part 101

      · 5+ years in a management or supervisory role

      Preferred:

      · >3 years’ experience leading Supplier Quality teams and projects

      · >3 years’ international quality regulatory experience

      Education

      Required:

      · Four year degree in science, life science or related discipline

      Qualifications

      · Knowledge of cGMP regulations with experience in external auditing

      · Strong understanding of 21 CFR Part 111 and international quality regulatory requirements for manufacture

      of regulated products

      · Extensive understanding of DSHEA and NLEA Labeling Regulations for Foods and Dietary Supplements

      · Highly organized with strong written and verbal skills and ability to work with all employees at various levels

      · Ability to develop and lead a team of professionals

      · Familiar with all aspects of Supplier Quality Management, including but not limited to CAPA and investigation management.

      · Ability to deal with difficult situations and various departments with tact, professionalism, and discretion and make risk based decisions in a timely manner.

      · Proficient in personal computer skills including electronic mail, project management, record keeping, and routine database activity, word processing, spreadsheets, graphics, etc.

      Licenses Registrations

      None required. Regulatory Affairs and/or Certified Quality Manager Certifications would be a plus.

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Jay, Production Supervisor

At GNC, we are all treated as individuals. The autonomy allows me to be strategic

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