Director of Quality Assurance (Greater New York City Metropolitan Area)

POSITION SUMMARY

This is a senior management level position reporting to the company’s Executive Vice President.

The ideal candidate will possess a strong Quality Assurance (QA) background in the pharma, medical device and biotech industries, and possess the practical ability to apply their QA background skills to the company’s logistics and supply chain services across multiple focused industries. The individual must be highly focused, proactive, detailed oriented and have the solid ability to think strategically and execute flawlessly. Strong leadership skills and adept at interfacing with internal and external Director, VP, C-suite executives, peers, direct reports, FDA and other QA executives. The individual must be extremely competent on ISO, cGMP and lean manufacturing processes, and have familiarity /experience with logistics and supply chain management. Candidate must have the skills to build a centralized quality organization to support a Life Sciences division in compliance with cGMP, FDA and other regulatory agency requirements, and to translate those elements across other company focused industries divisions within a currently decentralized QA structure.

Oversight of all quality assurance, continuous improvement and lean production standards to ensure clients’ expectations and company goals are met and/or exceeded. Responsible for administering the overall Quality Management Systems for the company. Additionally, must be a forward thinker who identifies areas of opportunities to strategically establish the company as a viable and leading global supply chain partner. Must be career oriented, as this position plays a vital role in the success and sustainability of the company quality and productivity standards.

 

DUTIES/RESPONSIBILITIES

  • Oversees all QA efforts to ensure the organization is compliant with all regulatory agencies
  • Develop and direct continuous improvement programs
  • Strategically, from a QA standpoint prepares the organization for future Life Sciences opportunities (i.e. Level II & III medical devices, cold chain, specialty products, etc.)
  • Lead all validation processes, auditing, analytics, reporting designs to insure compliance with FDA and other regulatory agencies
  • Manage QA personnel providing QA review and approval of validation protocols, completion reports, deviations, Engineering Change Orders
  • Lead & manage the ISO Quality Systems across all divisions and industries
  • Provides updated documents to conform to ISO standards & FDA cGMP
  • Conduct training for ISO, cGMP and maintain oversight of training files
  • Perform internal audits for ISO Quality Systems & FDA cGMP requirements
  • Direct corrective actions including planning, training and follow up
  • Maintain applicable logs to document compliance and quality indicators
  • Responsible for the update all quality records to be in conformance with system requirements
  • Complete and process metrics with timeliness and accuracy
  • Monitor and report error trends by commodity/employee
  • Primary contact for quality issues internally and externally
  • Responsible for coordinating, developing and implementing cost recovery and reduction initiatives
  • Design and implement procedures necessary to achieve quality results and continuous improvements in the production processes
  • Provides support to presentation development of the QA vision across all company focused industries.
  • Attend key meetings with Divisional leads and Sr. Leadership when appropriate

 

REQUIREMENTS

  • 5-10 years’ QA experience in the Life Sciences industry (pharma, medical devices and biotech)
  • Four Year College Degree
  • Experience with pharma FDA/cGMP standards & QA
  • Astute at putting together SOPs, establishing performance metrics/checks and balances to ensure customer satisfaction, FDA and other regulatory compliance
  • Strong strategic, leadership, data reporting, analytical and problem solving skills
  • Ability to work with individuals at all levels throughout the organization
  • Must be detail orientated and capable of providing clear, concise reports and direction
  • Proficient in ISO 9000 quality management standards
  • Strong communication skills both verbal and written; Excellent presentation skills
  • Lean manufacturing expertise (Six Sigma certification a plus)
  • Experience with batch/lot control/validation/clean room

 

REPORTS TO

Executive Vice President

 

SALARY/WAGE RANGE

Please forward salary requirements for consideration

 

BENEFITS

  • Group health insurance
  • 401K
  • Paid time off

 

HOW TO APPLY

jobs@walkerscm.com