Quality Assurance Manager

Company Info
Radnor, PA, United States

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Company Profile


Quality Assurance Manager


Saint Louis, MO 

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Job Description:

The Quality Assurance Manager (Manufacturing) is responsible for oversight of all quality assurance activities, as defined by the quality management system, applicable FDA regulations, ISO requirements, current and future certifications / accreditations and Management. Responsible to provide support and guidance to Quality Assurance associates. Advises Management on necessary continuous improvement efforts so that systems and processes are in line with overall company strategy, voice of the customer, regulatory standards, guidelines and quality policy. Strategically provides technical input and advises / implements necessary process and documentation changes. Makes decisions based on customer, associate and company best interests. Lead strategic Quality activities to support the Manufacturing group.



  • Acts as Management Representative for manufacturing quality.
  • Manages and provides direction to Quality Assurance department and associates.
  • Trains, motivates, monitors and evaluates performance of Quality Assurance department and associates.
  • Oversee Label Design team.
  • Direct CAPA program (currently knows as NCR) and Lead Auditor to ensure CAPA and audit programs (internal and external) are performing effectively and timely.
  • Lead Regulatory / 3rd party and customer audits, including audit preparation, documentation, follow-up, and closure.
  • Conduct internal audits for Quality Management System
  • Support supplier evaluation program, including supplier audit program.  Review program and advise purchasing where issues exist.
  • Oversee the application of the Quality Management Systems (QMS); maintain QMS software.
  • Provide technical support regarding the revision or implementation of process documentation, including procedures, work instructions, and forms.
  • Have working knowledge of and support compliance with IPEC and FDA Quality System Regulations (QSR); Maintain the integration of FDA regulations, and any other regulatory bodies, into the Quality Management System (QMS). 
  • Evaluate and advise management on current regulations and standards, new regulations and/or standards and proposed changes.  Provide strategic insight to senior management.
  • Support and advise necessary continuous improvement projects as a result of periodic trend reporting; management review; complaint investigation; supplier, customer, and internal audits; and any other relevant quality event.
  • Create, implement, and maintain process improvements, key initiatives, projects, and tasks, as assigned.
  • Conduct root cause analysis throughout the Manufacturing group.
  • Ensure organizational QMS training is in place; provide training as requested.  Prepare, conduct, and advise necessary training on quality assurance concepts and tools.
  • Lead Complaint Investigation efforts. 
  • Guide Management Review preparation and lead semi-annual meetings.  Advise Executive Management where data should be captured and appropriate metrics to ensure strategic objectives are met.
  • Conduct periodic review of complaint process, audit program, and related quality programs.
  • Maintain and manage cGMP at defined levels of compliance.
  • Ensure work product and technical reports provide clarity and accuracy.
  • Work directly with customers and suppliers to understand and communicate critical features, requirements and corrective actions, as well as supplier approvals and performance.
  • Coordinates objectives with production procedures in cooperation with other managers to maximize product reliability and minimize costs.
  • Ensures inspection activity for product throughout production cycle.
  • Performs other duties as assigned.​


  • Bachelor’s Degree in a life science discipline, or an equivalent combination of education and experience preferred; formal training and/or advanced courses are preferred
  • 7+ years progressive work experience in Quality Systems, combined with a demonstrated record of accomplishments as a Quality professional, and with strong customer orientation in a similar industry; previous supervisory experience preferred​


  • Must be familiar with relevant regulations
  • Strong knowledge of FDA and international Quality System rules and regulations
  • Strong oral and written communication skills
  • Strong interpersonal and organizational skills
  • Ability to take initiative, maintain confidentiality, meet deadlines, and lead people in a team environment essential
  • PC skills required (MS Word, Excel, PowerPoint, Access)