Quality Assurance Manager 

North Carolina 

Summary of the Position:.   Develops and deploys the quality system for entire manufacturing facilities to assure systems and procedures are compliant pursuant to government regulations, industry standards and Company specifications and policies.  Periodically reviews the suitability and effectiveness of the quality systems with Executive Management.  He/She has ultimate responsibility for making the quality decisions on the identity, purity, strength or composition of nutritional products in the human and animal health areas.  Responsible for management and oversight of all quality compliance and operation activities within   Quality Assurance (“QA”), Supplier Quality, New Product Development support and Package Engineering (“Quality Organization”).
Roles and Responsibilities:

• Manages the Quality Organization in support of business division or Companywide initiatives.
• Interfaces with Production, Regulatory Affairs, Marketing, New Product Development and other necessary departments to maintain awareness of Quality Operation activities.
• Responsible for results in terms of product quality and conformance to government regulations, industry standards, and Company policies.
• May act as the Management Representative for Quality
• Develops and deploys the Quality systems (e.g. CAPA, design control, process control) to ensure products conform to defined requirements.
• Understands and deploys processes to assure conformance to government regulations, industry standards and Company specifications and policies.
• Manages the team for regulatory inspections.
• Assesses and advises Executive Management on quality decisions.
• Manages interactions with vendors, suppliers and FDA inspectors concerning the quality of products, systems, and processes.
• Identifies and manages continuous improvement projects that may span multiple sections or departments with the objective of achieving quality, reliability and cost improvements.
• Maintain awareness of current government regulations and interface and interpret with Regulatory Affairs, to apply and implement these regulations to assure compliance.
• Acts as team member representative for Quality Operations on New Product Development
• Manages quality compliance for Contract Manufacturers
• Manages those individuals within the QA department that includes but is not limited to the following responsibilities:
  1. Management of GMP and job-specific training program
  2. Development and management of a CAPA (corrective action/preventive action) program to ensure the appropriate responses to deviation or audit deficiencies
  3. Review and approval of all SOPs
  4. Production process monitoring
  5. Assuring that all GMP requirements and regulations (including 21 CFR 111, Food Safety Modernization Act and  any other appropriate regulations are met through compliance with government regulations, industry standards, and Company specifications policies
  6. All protocol review and approval
  7. Batch record documentation review and approval
  8. Product/Raw material/Component release (following testing)
• Perform other assigned duties as may be required in meeting company objectives
• Communicate effectively with other departments within the organization and function within a team environment.

 
Minimum Requirements:  

• Strong Knowledge of FDA government regulatory requirements pertaining to the manufacturing of nutritional supplement and/or pharmaceutical products.
• Strong leadership and demonstrated success in managing a team.
• Strong analytical and problem-solving skills.
• Success working with multifunctional, global teams.
• Excellent interpersonal/communication/influencing/negotiation skills required.
• Demonstrated problem-solving skills.
• A high level of human relations skills in selecting, developing, and motivating people.
• Excellent motivational and cross-functional team building skills.

 
Education and Experience:  B.S. in science or engineering; advanced degree preferred.
Minimum of 10 years’ experience in Quality Assurance in the nutritional supplement and/or pharmaceutical products manufacturing industry; with 7 years management experience

For More Information, Apply or Contact Brad McMillan at 704-946-8209 or Brad@RPMReSearch.solutions