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6 дней назад

Manager, Supplier & Internal Auditor (Biotech)

151 000 - 176 000$
Формат работы
remote (только USA)/hybrid
Тип работы
fulltime
Грейд
senior
Английский
b2
Страна
US
Вакансия из списка Hirify.GlobalВакансия из Hirify Global, списка международных tech-компаний
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Описание вакансии

Текст:
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TL;DR
Manager, Supplier & Internal Auditor (Biotech): Planning and conducting supplier and internal audits for pharmaceutical, biotechnology, and medical device quality systems with an accent on regulatory compliance, supplier qualification, and CAPA effectiveness. Focus on risk-based audit planning, evaluating GMP/GLP/GCP/ICH and ISO 13485 compliance, documenting findings, and supporting inspection readiness.

Location: Hybrid in San Carlos, California, with a minimum of 3 days per week onsite; open to remote work.

Salary: $151,000–$176,000 annually in the San Francisco Bay Area; ranges may vary for non-California locations.

Company

Vaxcyte is a biotechnology company focused on vaccine development and operations.

What you will do

  • Plan, schedule, and conduct onsite and remote supplier audits for supplier qualification and ongoing oversight.
  • Execute internal audits of quality systems and operational processes against regulatory and internal requirements.
  • Prepare audit agendas, reports, observations, and supporting documentation.
  • Review supplier CAPA plans, verify corrective-action effectiveness, and support remediation follow-up.
  • Collaborate with Technical Operations, Supply Chain, Regulatory, and Quality Systems stakeholders to assess findings and risk.
  • Support inspection readiness, quality procedures, stakeholder training, and continuous improvement.

Requirements

  • Bachelor’s degree in Life Sciences or a related field.
  • 5+ years of Quality Assurance, auditing, or compliance experience in the pharmaceutical, biotechnology, or medical device industry.
  • Current auditor certification, such as ASQ Certified Quality Auditor or equivalent.
  • Strong working knowledge of GMP, GLP, GCP, ICH guidelines, and ISO 13485 requirements.
  • Demonstrated experience conducting supplier and/or internal audits, with strong written communication and documentation skills.
  • Ability to travel, work independently, manage multiple priorities, and collaborate cross-functionally.

Nice to have

  • Vaccine industry experience.
  • Additional combinations of education and experience may be considered.

Culture & Benefits

  • Hybrid or remote work arrangement, subject to business needs, responsibilities, and company policy.
  • Comprehensive benefits package.
  • Equity component included in the compensation package.

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