Quality Assurance Leader: Regulatory Excellence & Strategy

PolyPeptide Laboratories B.V.; Torrance (CA); Presencial; USD 160 000 - 210 000; Tempo integral

Resumo da oferta

PolyPeptide Laboratories B.V. in Torrance, CA, seeks a Head of Quality Assurance to provide strategic leadership and operational oversight for the Quality Assurance organization.

The role ensures compliance with FDA/EMA regulations, ICH guidelines, and cGMPs, while guiding deviations, CAPA, and product release processes across the site. You will drive long-term quality strategy, readiness for inspections, and collaboration with Regulatory Affairs, Manufacturing, and Commercial teams to support

Qualificações

• Bachelor’s or Master’s degree in Chemistry, Pharmaceutical Sciences, Life Sciences, or a related discipline.
• 10+ years of progressive Quality Assurance experience in a regulated environment.
• Minimum of 5 years in a senior QA leadership role.
• Experience leading teams and managing complex Quality operations.
• Experience with peptide or oligonucleotide manufacturing is highly desirable.

Responsabilidades

• Provide strategic leadership for the site Quality Assurance organization.
• Oversee QA activities: deviations, batch record review, product release, CAPA, change control, supplier quality, complaints, document control, annual product reviews, GMP training.
• Maintain regulatory inspection readiness and support regulatory inspections and customer audits.
• Partner with Regulatory Affairs, Manufacturing, Development, Commercial, and Corporate Quality to support projects and submissions.
• Develop next generation of Quality leaders and drive continuous improvement.

Conhecimentos

QA Leadership

GMP Knowledge

Regulatory Affairs

Cross-functional Leadership

Quality Systems

Audits & Inspections

Deviations & CAPA

Change Control

Formação académica

Bachelor’s or Master’s in Chemistry/Pharma

Descrição da oferta de emprego

PolyPeptide Laboratories B.V. in Torrance, CA, seeks a Head of Quality Assurance to provide strategic leadership and operational oversight for the Quality Assurance organization.

The role ensures compliance with FDA/EMA regulations, ICH guidelines, and cGMPs, while guiding deviations, CAPA, and product release processes across the site. You will drive long-term quality strategy, readiness for inspections, and collaboration with Regulatory Affairs, Manufacturing, and Commercial teams to support