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Job Details

Senior Director Quality Assurance

Company: EPM Scientific
Location: New York
Reference: ARTR041318515
Closing Date: 27 Apr 18
Type: Permanent
Salary (£): 100,000+
Benefits:

Job Summary:

Senior Director of Quality AssuranceSenior Director of Quality AssuranceNY, NYCompetitive Salary + excellent bonus + excellent benefitsWe have partnered on a search for...

Requirements:

Senior Director of Quality Assurance

  • Senior Director of Quality Assurance
  • NY, NY
  • Competitive Salary + excellent bonus + excellent benefits

We have partnered on a search for a Senior Director of Quality Assurance with an up and coming gene therapy company based in New York City. This company is focused on pioneering genetic solutions to treat various rare and orphan diseases. Our client has just received FDA approval for two of its indications to enter the first stage of clinical trials so this is the perfect opportunity to get in with an exciting company with many opportunities for growth as their drugs enter the later stages of clinical trials. In this role you will have the opportunity to shape/influence the direction of the QA group as a whole.

The Senior Director of Quality Assurance will have the following responsibilities:

The Senior Director of Quality Assurance is responsible for the strategy, implementation and leadership of the Quality organization and is accountable for the continuous development, execution and administration of a comprehensive GxP Quality System meeting all compliance requirements pertaining to Good Laboratory Practices (GLP), Good Clinical Practices (GCP) and Good Manufacturing Practices (GMP), ICH and EMA regulations.

  • Develop and implement processes, procedures, and systems to perform critical activities in an efficient and effective manner to assure compliance with applicable regulations and company standards.
  • Quality management of CMOs, CROs, contract test laboratories and other vendor services to ensure compliance with manufacturing and testing of company products.
  • Establish and maintain phase appropriate GMP compliance for product manufacturing, testing, and stability; ensure appropriate review and assessment of production records, in-process and release testing methods, specifications, validations, reference materials and test results.
  • Review and edit Quality Agreements, contracts, supply agreements, etc., provide quality input to project/program plans, master service agreements and statements of work.
  • Provide operational leadership and expertise in the development, implementation, and training of cGMP compliant quality systems, such as document control, change control, investigations, deviations, CAPA, and product/customer complaints.

The ideal candidate will have the following skill set:

  • Experience managing CMO/CRO relationships and projects
  • Demonstrated knowledge of US and EU cGMPs
  • Extensive experience in the biotechnology or biopharmaceutical manufacturing industry with prior experience in QA focused on gene therapy (AAV or LVV preferred) 
  • Excellent written and verbal communication skills, analytic and problem-solving
  • BA/BS/University degree in Life/Health Sciences required( advanced degree preferred).

 


 

 

 


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Contact Information:

Address:  Head Office
Ground Floor 21 Lombard Street London
EC3V 9AH
England
Tel:  +44 (0)20 3758 8855
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