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Director - GLP Quality Assurance and Validation

Reference Number: 3115
Location: NY

Our client is a rapidly growing biotechnology company.  They have asked us to assist them in their search for a Director - GLP Quality Assurance and Validation.

Major tasks and responsibilities will include:

  • Manages quality assurance activities for all in-house GLP regulated activities.
  • Manages qualification and provides quality oversight of third parties contracted to perform any functions in support of the GLP regulated studies or validation projects.
  • Plans and conducts GLP audits of GLP regulated third parties to assess compliance with all pertinent regulations as well as with company SOPs. Oversees audits of validation projects to assess compliance with all pertinent regulations as well as with any company SOPs.
  • Works with the Executive Director - QA to assure alignment and compliance with the company’s Quality Management System, supports assessments of compliance and defines metrics to determine performance objectives.
  • Collaborates with Research & Development and Clinical Operations staff to identify, evaluate, and recommend solutions to issues identified in the performance of GLP audits.
  • Collaborates with Information Technology or other departments, as necessary, to identify, evaluate, and recommend solutions to issues identified in the performance of validation audits.
  • Oversees the management of both the internal and external audit programs by assigning audits to appropriate Quality associates and helps ensure that Quality internal and external audit reports are issued in a timely manner.
  • Works with the company’s Senior Management to identify, evaluate, and recommend solutions to issues identified during the performance of internal audits.
  • Collects data from internal/external audits and reports metrics and trends in order to implement process improvements.
  • Assists with internal and external training of the company’s staff and vendors.
  • Assists Vice President of Quality during FDA inspections.
  • Prepares clear and concise written reports of audit observations, including an assessment of compliance. Assesses adequacy of action plan. Conducts follow up activities as needed to monitor corrective actions.
  • Assists with internal GLP and training.
  • Leads initiatives on GLP, compliance and associated internal audits.
  • Works in conjunction with the Executive Director, QA to align SOPs, policies and procedures with the company’s Quality Management System.
  • Acts as a compliance resource to the company’s employees.

We seek candidates with the following qualifications:

  • BA in a scientific or health-related field is required.
  • MA in a scientific or health related field is preferred.
  • A minimum of 10-15 years of Quality experience in the biotechnology or pharmaceutical industries required, of which 6-8 years are in auditing and at least 5 years are in a senior management of Quality role.
  • Advanced understanding of the application of GLPs, FDA regulations and ICH guidelines is required.
  • Expert knowledge of GLP requirements.
  • Maintains professional expertise and knowledge of local and international regulations, by attending courses and networking with QA colleagues.
  • Must be proficient in MS Office Suite and QUMAS.
  • Good interpersonal skills, ability to interact effectively with all levels of personnel within the organization and externally with investigators and study site personnel.
  • Ability to review documents, processes and procedures as it relates to clinical trial activities; to identify issues/problem areas; assess compliance; communicate findings to the clinical teams.
  • Demonstrated leadership and project management skills.

 

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 3115. No calls or faxes, please. Include your daytime phone number and we will contact you confidentially or reply to your email.