AD/Director, Quality Assurance

Woburn Permanent USD140,000 - USD160,000
  • Join a growing CRO focused on small molecules, biologics and CGT products
  • Exciting opportunity to direct a team of Quality Professionals

About Our Client

A preclinical Contract Research Organization located in Woburn, Massachusetts

Job Description

  • Develop and maintain a Quality culture on site, such that the Quality team provides leadership and coaching to ensure GLP and GMP best practices are embedded throughout the site
  • Direct a team of Quality professionals and ensure the Quality department remains engaged and motivated
  • Effectively manage and mentor Quality staff to emphasize positional responsibility, personnel development and succession planning throughout the unit
  • Continually review the operation of the Quality function on-site, and deliver a program of continual improvement
  • Serve as the primary Quality resource and provide strong leadership in support of GMP and GLP Quality systems, such as Investigations, Change Control, Out-of-Specifications, CAPA, Raw Materials, Risk Assessment and Training
  • Provide direct oversight of activities related to participation in Regulatory Agency inspections and client audits
  • Develop and drive continual GMP and GLP Quality standards
  • Track Quality Metrics and provide feedback and results to executive staff regarding key Quality related initiatives of continuous improvement, ensuring best practices
  • Review and negotiate client Quality Agreements
  • Interact with other functional areas to define and execute project requirements and objectives and maintain compliance across the site
  • Maintain the facility in an inspection ready state for Regulatory Agency inspections and client audits
  • Enforce and ensure compliance with Standard Operating Procedures
  • Support management needs in other related duties, as required

MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.

The Successful Applicant

  • Minimum fifteen years' experience working within the pharmaceutical or biotechnology industry, in a GLP/GMP environment in a Quality Assurance management role
  • A Bachelor's degree in a scientific field
  • Experience in Regulatory Inspection participation is required
  • Attention to detail
  • Excellent communication and interpersonal skills
  • Excellent organizational skills

What's on Offer

Offers a variety of benefits allowing employees the opportunity to customize a comprehensive benefits package that meets their personal needs.

Meghan Landry
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Job summary

Life Sciences
Sub Sector
Healthcare / Pharmaceutical
Contract Type
Consultant name
Meghan Landry
Job Reference