Primary Location: Greenville, SC
Job Tile: External Quality Operations Director
Job Number: 2017-48698
Date Posted: 4-28-2017
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.
STRATEGIC – THIS INDIVIDUAL DIRECTLY OVERSEES THESE STRATEGIC ACTIVITIES:
TACTICAL – DIRECTS THE ACTIVITIES OF SUPPLIER QUALITY MANAGEMENT STAFF TO ENSURE:
· 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
· >3 years’ experience leading Supplier Quality teams and projects
· >3 years’ international quality regulatory experience
· Four year degree in science, life science or related discipline
· 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.
None required. Regulatory Affairs and/or Certified Quality Manager Certifications would be a plus.
Hubert, Product Development Manager
There is always an opportunity to be creative and innovative. We require unique formula… development strategies for product development and our facility allows access to a variety of advanced manufacturing equipment and machinery. The company offers tremendous growth opportunities for anyone eager to learn and become an expert in dietary supplement process development.