Mantell Associates is partnered with a rapidly growing CDMO who are seeking a Senior Manager of Quality Assurance to join their talented team.

Senior Quality Assurance Manager - Responsibilities:

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• 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 oversee the Quality on the Floor Program responsible for 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

Senior Quality Assurance Manager - Requirements:

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• Scientific degree and strong experience in Quality Assurance leadership in a GMP related field within a biotechnology, biologics, or pharmaceutical manufacturing facility

• Proven experience managing a team

• GMP compliance knowledge

• Able to efficiently prioritize workload across the team

• Team player with 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 organization

Mantell Associates is a specialist Pharmaceutical and Life Sciences headhunting firm. For more information on this role, please contact us at +1 (786) 245-8592.