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Director QA Compliance

Reference Number: 2562
Location: NJ

Our client is a specialty biopharmaceutical company.  They have asked us to assist them in their search for a Director QA Compliance.  The Director QA Compliance is primarily responsible for the internal and external audit program, Supplier Quality Management, regulatory intelligence and readiness, and corporate quality assurance reviewer/approver.  The Director ensures compliance with applicable regulations for the company’s products including products at different clinical stages.  In addition, the position assists other site quality heads in their function as needed.  The position interacts with internal departments Facilities, Regulatory Affairs, Product Development, Engineering, Project Management, Legal, Materials, and Logistics.  The position has interaction with external entities including contractors and suppliers.  The Director QA Compliance monitors the compliance level of manufacturing activities by evaluating and reporting quality data.  A problem solver with the ability to evaluate quality problems and organize and present complex data in a simple and concise manner; a risk based approach to implementation of regulatory requirements and problem solving; must possess excellent communication, organizational, people and managerial skills.

Responsibilities will include:

  • Oversee Internal and External Audit
  • Prepare sites for regulatory inspections via a readiness program
  • Serve as Corporate Quality Assurance reviewer and approver
  • Generate trend reports as they relate to quality activities
  • Revise quality SOPs and Policies
  • Review and approve validation protocols and report
  • Identify and implement issues and opportunities for improvements
  • Support the Purchasing Control Program and the implementation of Quality Agreements
  • Evaluate and streamline departmental procedures and practices
  • Collect, evaluate, and trend quality data; implement quality metrics
  • Support FDA and Third Party InspectionSupport Management Reviews of Quality System Activities 
 We seek candidates with the following qualifications:
  • Bachelor’s Degree in a scientific related discipline, advanced degree preferred, with a minimum of 8 years experience in an FDA regulated industry 
  • 6 to 8 years experience with pharmaceuticals and/or medical devices in a quality function 
  • Excellent organizational, managerial, and people skills required
  • Must have experience managing quality departments and managing quality programs (e.g., audit programs, supplier management)
  • Experience interacting with FDA inspections preferred
  • Ability to interpret regulatory requirements and implement appropriately
  • Ability to evaluate data and quality issues
  • Organize and present complex data in a simple and concise manner
 Do you have the skills and experience we seek and want to advance your career with a small but rapidly growing biopharmaceutical company?  If so, please email your resume as a Word document to us today.  Please include your daytime phone number and we will contact you confidentially or reply to your email.