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Senior Manager, QA - GLP

Reference Number: 3171
Location: MA

Our client is a global biopharmaceutical company.  They have asked us to assist them in their search for a Senior Manager, QA - GLP.

Major tasks and responsibilities will include:

  • Demonstrates strong expertise related to understanding the principles and application of quality and regulatory compliance related to GLP regulated activities.
  • Demonstrates strong technical expertise and auditing skills in support of nonclinical and clinical bioanalysis.
  • Demonstrates a strong ability to successfully plan, adjust, manage and optimize all resources for advancement of all goals and objectives.
  • Demonstrates a strong aptitude for facilitating group or project team endeavors, and building team unity.
  • Demonstrates a strong ability to effectively communicate and influence the outcomes of the decision making process.
  • Participates and contributes to projects while meeting all deliverables and timelines.
  • Maintains a contemporary knowledge of current industry trends, standards and methodologies as it relates to GLP quality systems and management.
  • Conducts presentations on quality issues, initiatives and projects at cross functional meetings.
  • Fosters the demonstration of the company’s core values and leadership behaviors in others.
  • Developments, implementations, and oversight of quality activities in support of GLP activities conducted or monitored by the company. These activities focus around the qualification and monitoring of GLP Vendors and oversight of internal GLP activities.
  • Monitors each study to assure management that the facilities, equipment, personnel, methods, practices, records, and controls are in conformance with the regulations.
  • Maintains complete separation and independence from personnel engaged in the direction and conduct of a study.
  • Inspects each nonclinical laboratory study at intervals adequate to assure the integrity of a study and maintain written and properly signed records of each periodic inspection showing the date of the inspection, the study inspected, the phase or segment of the study inspected, the person performing the inspection, findings and problems, action recommended and taken to resolve existing problems, and any scheduled date for re-inspection.
  • Determines that no deviations from approved protocols or standard operating procedures were made without proper authorization and documentation.

We seek candidates with the following qualifications:

  • MS in a scientific or allied health field and 5 plus years of relevant GLP work experience, or BS in a scientific or allied health field and 8 plus years of relevant GLP work experience, or relevant comparable background.
  • Demonstrates leadership skills are critical to this role.
  • 20-25% travel.

 

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 3171. No calls or faxes, please. Include your daytime phone number and we will contact you confidentially or reply to your email.