Senior Manager, Computer System Validation QA
New
B
BridgeBioBiotech
Remote - USAFull-TimeManager
Salary$145,000 — $170,000 USD
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Job Details
- Experience
- 8+ years of experience in quality systems development and maintenance within clinical and commercial-stage pharmaceutical or biotech companies
- Required Skills
- Quality Assurance
Requirements
- Bachelor’s or Master’s degree in software, computer engineering, or technical field.
- 8+ years of experience in quality systems development and maintenance within clinical and commercial-stage pharmaceutical or biotech companies.
- Demonstrated expertise in GxP computerized system validation/assurance (CSV/CSA) and system lifecycle management.
- Strong knowledge of 21 CFR Part 11, FDA predicate rules, EU Annex 11, ICH GCP, and EU GVP.
- Knowledge of risk-based lifecycle practices such as GAMP.
- Experience developing GxP SOPs and training personnel on compliance requirements.
- Ability to influence and drive cross-functional teams.
- Excellent attention to detail and strong organizational skills.
- Effective communication skills both written and verbal.
- Quarterly travel to the San Francisco office.
Responsibilities
- Provide QA oversight of the GCP/GVP computer system validation lifecycle.
- Review and approve computer system risk assessments and validation deliverables.
- Participate in periodic system reviews and remediate compliance gaps.
- Collaborate with IT and business stakeholders to enforce validation and data integrity requirements.
- Manage the audit program, including audit report and CAPA reviews.
- Drive continuous improvement for QMS and validated GxP systems.
- Support inspection readiness and serve as a QA CSV subject matter expert.
- Support AI governance as the GCP/GVP Quality representative.
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