​​Mantell Associates is partnered with an exciting rapidly growing organisation who are seeking aSenior Manager of Quality Assuranceto join their talented team.  

The Senior Manager of Quality Assurance is responsible for overseeing all product quality and new production introduction activities. Successful candidates will be a team player and have exceptional communication skills, a concern for excellence, ability to develop and mentor a team, and a high ability to collaborate with various levels of the organisation.  ​

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Senior Manager Of Quality Assurance Responsibilities:

• Develop and oversee the New Product Introduction (NPI) process responsible for onboarding new customers and products to ensure successful clinical and commercial drug product manufacturing

• Develop and oversee the Product Quality Team responsible for disposition of batches, tracking batch release, and partnering with other departments to close out all required deliverables to support product disposition

• Develop and over see the Quality on the Floor Program responsible for AQL of visual inspection and packaging operations

• Provide strategic guidance to resolve complex investigations and product quality issues

• Reviews and approves Commissioning and Validation protocols and final reports

• Reviews and approves QC stability study summaries, protocols, and final reports

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Senior Manager Of Quality Assurance Requirements:

• Master’s Degree and 5+ years’ experience in Quality Assurance leadership in a GMP related field within a biotechnology, biologics, or pharmaceutical manufacturing facility

  OR  Bachelor’s Degree and 10+ years’ experience in Quality Assurance in a GMP related field within a biotechnology, biologics, or pharmaceutical manufacturing facility

• Must have proven track record with batch disposition activities

• GMP compliance knowledge including 21CFR210, 211, 820, as well as EMA Annex 1 and FDA Guidance on Aseptic Processing

• Work occurs in a fast-paced environment. Individual must be able to efficiently prioritize own work as well as the work of their team

• Experience in managing a team

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Mantell Associatesis a specialist Pharmaceutical and Life Sciences headhunting firm. For more information on this role, please contact us at +44 (0)20 3854 7700.