BridgeBio Pharma
Manager, Quality Systems and Risk Management
Remote - USA · Full-time
Sponsorship not specified$126k-$153kDetected 14 days ago
A/B TestingComplianceProject ManagementExcelProcess ImprovementGMPFDA RegulatoryResearchProblem SolvingOrganizational SkillsMicrosoft OfficeLean ManufacturingGxP
About the role
- Mavericks Wanted When was the last time you achieved the impossible?
- Together we define white space, push boundaries, and empower people to solve problems.
- Together, we'll ask "why not?" and help reengineer the future of biopharma.
Responsibilities
- Own and drive formal risk management activities across the organization by leading risk assessments, maintaining risk registers, and applying risk frameworks such as ICH Q9 and FMEA.
- Support the maintenance and continuous improvement of the QMS.
- Manage the preparation and compilation of APQR reports.
- Collaborate with internal and external key stakeholders for compilation of quality metrics, APQR, etc.
- Assist in executing process improvement initiatives using Lean Six Sigma principles, including data gathering, root cause analysis support, and CAPA follow-through.
- Establish work priorities to meet targets and timelines and effectively manage competing priorities with minimal escalations.
- This model allows science and small teams of experts to lead the way.
- We build bridges to groundbreaking advancements in rare disease, and develop life-changing medicines for patients with unmet needs as fast as humanly possible.
Requirements
- Bachelor's degree or equivalent in pharmacy, science, mathematics or engineering required
- Knowledge of regulatory requirements and guidelines (e.g., FDA, ICH, EU GMP, GDP)
- Proficiency in eQMS preferably with prior Veeva experience, Microsoft Office, Excel, Google Docs, etc.
- Experience with commercial marketed products
- Assist in preparation, review and revision of Standard Operating Procedures (SOPs), as required.
Nice to have
- Knowledge of Lean Six Sigma Methodologies or equivalent is preferred
Compensation
- $126,400 - $152,700 USD
- Market-leading compensation
- They also play a hands-on role in key quality processes such as Annual Product Quality Review (APQR) compilation and the generation of quality metrics for Quality Management Reviews (QMRs), working closely with the Sr.
Benefits
- Employee Stock Purchase Program (ESPP)
- Pre-tax commuter benefits (transit and parking)
- Referral bonus for hired candidates
- As a global company, our comprehensive benefits may vary based on location.
Company info
- Contribute to improvement projects aimed at reducing cycle times and enhancing quality system efficiency, and apply Lean Six Sigma tools as part of ongoing quality work.
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