Senior QA Leader — GMP/API Excellence (Onsite)

Veranova

Northern (KY)

Híbrido

USD 155.000 - 175.000

Jornada completa

hace 24 horas
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Ventajas ofrecidas por este puesto de trabajo

Health & Wellness
401(k) Plan with company match
Tuition Assistance

Descripción de la vacante

Veranova seeks a Senior Manager, Quality Assurance (QA) to lead the QA team, oversee manufacturing quality oversight, batch review and release, and ensure GMP compliance across operations at the Devens, MA facility.

The role requires extensive QA leadership experience in an FDA-regulated environment, with strong knowledge of GMP, ICH Q7 and 21 CFR Part 11. Salary ranges reflect market data and internal equity.

Formación

  • BS or MS in Chemistry, Engineering or related field required.
  • Minimum of 7 years of supervisory experience; proven ability to lead and coach teams.
  • Experience with GMP, ICH Q7, and 21 CFR Part 11; FDA regulatory knowledge and quality systems.

Responsabilidades

  • Lead QA teams for batch record review, disposition, and on-the-floor QA support to ensure GMP compliance.
  • Develop, revise SOPs and Quality Policies as needed.
  • Manage training content and programs for Quality Assurance staff.

Educación

BS or MS in Chemistry, Engineering or related field

Herramientas

LIMS

Descripción del empleo

Veranova seeks a Senior Manager, Quality Assurance (QA) to lead the QA team, oversee manufacturing quality oversight, batch review and release, and ensure GMP compliance across operations at the Devens, MA facility.

The role requires extensive QA leadership experience in an FDA-regulated environment, with strong knowledge of GMP, ICH Q7 and 21 CFR Part 11. Salary ranges reflect market data and internal equity.

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