Sr. Quality/Regulatory Manager

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Safetec of America, Inc., a 25+ year manufacturer of infection control and first-aid products, is seeking a Sr. Quality & Regulatory Manager with experience in managing quality systems in an OTC manufacturing environment. We are a family owned, local business with a reputation of retaining employees because we treat them like family.

Responsibilities:

  • Oversee the Company’s Quality Control and Quality Assurance practices in a cGMP compliant manner
  • Establishing process/quality standards based on customer expectations while maintaining FDA/cGMP compliance
  • Serve as company’s representative for any Customer/Regulatory inspections
  • Interface with external and internal personnel to drive quality and milestones
  • Handle audit planning, conduct, findings, responses, and corrective and preventative actions
  • Perform and direct quality system internal audit activities and drive improvements within the local quality system
  • Maintain current understanding of regulatory agency policies and guidance as it pertains to Quality Assurance matters and inform management of significant changes
  • Direct quality systems to achieve compliance and consistency in management reviews, CAPA, design change, document control, validation, process control, complaints, training, etc.
  • Provide employee training on cGMP compliance related topics, policies and procedures.
  • Analyze data to identify areas for improvement in quality system
  • Investigate customer complaints and nonconforming issues. Implement appropriate and effective corrective and preventive measure(s)
  • Implement qualification and validation practices as needed
  • Oversee high-level quality control practices, including the creation of ingredient and finished product specifications
  • Work with vendors to obtain needed regulatory information for ingredients and with customers to respond to regulatory inquiries
  • Organize personnel in respective departments and implement appropriate key performance indicators  

Required skills and Work Experience:

  • Ten plus years of management experience in a manufacturing setting
  • Five plus years of FDA and cGMP experience required
  • Knowledge of Medical Device Manufacturing or Medical Device Quality Assurance
  • Knowledge of the industry’s regulatory environment, specifically with 21 CFR 210/211/820
  • Bachelor’s degree or equivalent work experience
  • Strong leadership ability, project management and team facilitation skills
  • Strong communication skills and can work well with others
  • Knowledge of MS Word, Excel, Outlook and other computer programs
  • Experience in managing cross-functional teams commonly found in a manufacturing organization

 

Location: Buffalo, NY
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Apply at: https://safetec-of-america-inc.hireonthego.com/job/94329/sr-quality-regulatory-manager