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Director - Quality Systems and Compliance

Reference Number: 2930
Location: East Coast

Our client is a leading pharmaceutical company.  They have asked us to assist them in their search for a Director - Quality Systems and Compliance.

Major tasks and responsibilities will include:

  • Maintains the site in a perpetual state of inspection readiness.
  • Assists in the building of world-class/scalable quality systems.
  • Ensures that all site related Quality Assurance activities are conducted in compliance with corporate standards and applicable regulations.
  • Provides QA system oversight of contract manufacturing organizations.
  • Provides expertise and guidance in interpreting government regulations and guidelines, both US and ROW.
  • Performance of internal and external GMP audits utilizing a risk based strategy.
  • Manages and oversees site regulatory inspections (FDA, EMEA, etc.).
  • Develops, coaches and trains personnel to ensure that adequate technical understanding is built in to day-to-day operations.
  • Manages and measures work through metrics along with good overall time management.
  • Effectively Mentors and develops staff.
  • Independently identifies and resolves complex problems through good decision quality utilizing both functional and scientific technical skills.
  • Establishes group goals and objectives, ensuring they support company goals and objectives.

We seek candidates with the following qualifications:

  • Bachelor’s of Science Degree with 15 years of experience, or Masters of Science Degree with 10-12 years of experience.
  • At least 10 years in a managerial role with prior experience in the design and licensure of biopharmaceutical manufacturing facilities, applying risk management tools and techniques, and developing or re-designing Quality Systems.
  • Skilled in operational excellence tools and uses them to drive quality improvements.
  • Tactfully manages conflict and is not afraid stand alone on issues.
  • Proven track record in developing or leading teams with an ability to lead multiple teams within and outside the organization.
  • Ability to work collaboratively with strong listening skills.
  • Skilled at taking strategic initiatives and translating them into tactical solutions.
  • Talented at developing strategy and negotiating effectively with senior management to gain approval.
  • Able to professionally communicate verbally, in writing and represent the function effectively.
  • Ability to effectively present complex data and strategy to large groups.

 

Do you have the skills and experience we seek and want to advance your career with one of the world’s leading companies? If so, please email your resume as a Word attachment to us, reference 2930. No calls or faxes, please. Include your daytime phone number and we will contact you confidentially or reply to your email.