Senior Director, Site Quality & Compliance

Fraser Dove International; North Carolina; Presencial; USD 190.000 - 270.000; Tempo integral

Resumo da vaga

Fraser Dove International is seeking a strategic Senior Director, Site Quality Head to lead end-to-end QA and QC across the site in a regulated biopharmaceutical manufacturing environment.

You will own GMP compliance, drive quality systems, oversee analytics and microbiology, and partner with global quality and cross-functional teams to prepare for regulatory inspections and continual improvement.

Qualificações

• 8+ years in pharmaceutical manufacturing, with hands-on biologics experience.
• In-depth knowledge of cGMP regulations including 21 CFR Parts 210 and 211.
• Proven track record leading regulatory inspections (FDA audits).
• Strong leadership, coaching, and team development abilities.

Responsabilidades

• Lead QA and QC activities across site, including analytics and microbiology.
• Hold final accountability for GMP compliance and regulatory results.
• Drive continuous improvement of quality systems (CAPAs, deviations, change control).
• Collaborate with global quality and cross-functional stakeholders.
• Serve on site leadership team guiding strategic decisions.
• Develop and coach a multi-disciplinary QA/QC team.

Conhecimentos

CDMO leadership

Pharma manufacturing

cGMP knowledge

FDA inspections

Stakeholder management

People leadership

Biologic drug substance

Formação

BSc in a scientific discipline

Descrição da vaga

Fraser Dove International is seeking a strategic Senior Director, Site Quality Head to lead end-to-end QA and QC across the site in a regulated biopharmaceutical manufacturing environment.

You will own GMP compliance, drive quality systems, oversee analytics and microbiology, and partner with global quality and cross-functional teams to prepare for regulatory inspections and continual improvement.