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Manager, Global Quality Compliance, GMP Environment

Reference Number: 2915
Location: Northeast

Our client is one of the world’s leading generics and specialty pharmaceutical companies.  They have asked us to assist them in their search for a Manager, Global Quality Compliance, GMP Environment.

Major tasks and responsibilities will include:

  • Performs independent evaluations of quality systems and practices at sites located around the globe taking into consideration national and international regulations as applicable.
  • Assists in the evaluation of global compliance metrics to determine trends and opportunities for continuous compliance and quality improvement.
  • Identifies potential problems and coordinates resolution to issues prior to their having an adverse effect on the established business.
  • Provides guidance on quality/compliance improvement as needed to assure sites are always prepared for Regulatory Agency inspections.
  • Prepares and maintains schedules, meeting agenda, and evaluation reports.
  • Prepares executive summaries and reports based on evaluations conducted.
  • Stays current with industry standards and interpretations of key regulations.
  • Efficiently coordinates travel in order to work within budgetary commitments while meeting global quality demands.

We seek candidates with the following qualifications:

  • A minimum of a Bachelor's degree (or equivalent) and a minimum of six years of relevant pharmaceutical compliance/quality experience are required.  However, a combination of experience and/or education will be taken into consideration.
  • Certified Quality Auditor certification desired.
  • A sound knowledge of applicable cGMP regulations and expectations sufficient to readily interpret, lead discussion, and provide guidance based on the applicability of the regulations to the subject being evaluated.  Must be familiar with all other GXP concepts.
  • Excellent communication and negotiating skills.  Must be articulate in both written and oral communications including diplomatic discussion of required corrective actions with business partners.
  • Must be able to review, interpret, and discuss governing regulations, precedent interpretations, and current application.
  • Must be adept at independent decision-making.
  • Must be proficient in leading discussions of complex topics and have a working knowledge of Microsoft Office including Word, Excel and Lotus Notes.
  • Requires domestic and international travel (approximately 50% of the time).

 

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 2915. No calls or faxes, please. Include your daytime phone number and we will contact you confidentially or reply to your email.