Manager, Quality Systems and Risk Management
B
BridgeBioBiotechnology / Pharmaceutical
Remote - USAFull-TimeManager
Salary$126,400 — $152,700 USD
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Job Details
- Experience
- A minimum of 8 years of experience working in a Biotech or Pharmaceutical FDA regulated industry in QA or a related field
- Required Skills
- Risk Management
Requirements
- Bachelor’s degree in pharmacy, science, mathematics, or engineering.
- Minimum of 8 years of experience in QA or a related field within an FDA-regulated biotech or pharmaceutical industry.
- Strong experience leading formal risk management activities including risk identification, assessment, and mitigation.
- Proficiency in tools such as FMEA, risk ranking, and ICH Q9 frameworks.
- Deep knowledge of regulatory requirements and guidelines (FDA, ICH, EU GMP, GDP).
- Experience with commercial marketed products.
- Proficiency in eQMS (Veeva preferred), Microsoft Office, Excel, and Google Docs.
- Excellent analytical, problem-solving, and project management skills with high attention to detail.
- Lean Six Sigma methodology knowledge is preferred.
Responsibilities
- Own and drive formal risk management activities by leading risk assessments and maintaining risk registers using ICH Q9 and FMEA frameworks.
- Support the maintenance and continuous improvement of the QMS and participate in the implementation of new Veeva Vault QMS modules.
- Manage the preparation and compilation of Annual Product Quality Review (APQR) reports and ensure timely completion.
- Generate and analyze quality metrics and KPIs for Quality Management Reviews (QMRs) to identify trends and improvement opportunities.
- Execute process improvement initiatives using Lean Six Sigma principles including data gathering, root cause analysis, and CAPA follow-through.
- Participate in audits and regulatory inspections to ensure compliance with GxP standards.
- Prepare, review, and revise Standard Operating Procedures (SOPs) as required.
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