6 дней назад
Manager, Supplier & Internal Auditor (Biotech)
151 000 - 176 000$
Мэтч & Сопровод
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Описание вакансии
Текст:
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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