Manager/Sr. Manager, QA

Mavericks Wanted

When was the last time you achieved the impossible? If that thought feels overwhelming, you might want to pause here, but if it sparks excitement...read on
 
In 2015, we pioneered a “moneyball for biotech” approach, pooling projects and promising early-stage research from academia together under one financial umbrella to reduce risk and unleash innovation. 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. 
 
Together we define white space, push boundaries and empower people to solve problems. If you're someone who defies convention, join us and work alongside some of the most respected minds in the industry. Together, we'll ask "why not?" and help reengineer the future of biopharma.

Affiliate Overview

QED Therapeutics, an affiliate within BridgeBio Pharma, focuses on developing targeted treatments for FGFR-driven skeletal dysplasia, particularly Achondroplasia. Achondroplasia is the most common form of genetically driven short stature, which causes potentially debilitating medical complications. With our experimental therapeutic candidate, infigratinib, we seek to provide an option for children living with Achondroplasia and their families.

What You’ll Do

The Manager/Sr. Manager of GMP QA Manufacturing provides on-the-floor quality oversight for GMP manufacturing activities related to API and Finished Drug Product. This role ensures compliance with global regulatory standards (21 CFR Parts 210/211, EU GMP, ICH Q7, ICH Q10) and internal quality systems, while supporting efficient and compliant product release.

The Manager/Sr. Manager reviews and approves executed batch records, deviations, investigations, change controls, and associated documentation. They make quality recommendations on the release of API and finished products, ensuring that only compliant materials meeting all specifications are released for use or distribution.   

Responsibilities

1. GMP Oversight and Compliance

• Provide real-time QA oversight during manufacturing, packaging, labeling, and testing activities for API and Finished Drug Product
• Ensure that production operations comply with approved batch records, SOPs, and GMP regulations
• Perform line clearance, in-process checks, and review of critical operations
• Support internal and external audits, regulatory inspections, and readiness programs

2. Batch Record Review and Product Release

• Review executed batch production and laboratory control records for completeness, accuracy, and compliance
• Assess and verify that all critical process parameters and quality attributes are met prior to batch release
• Ensure all associated documentation (deviations, change controls, investigations, analytical results, environmental monitoring, etc.) is resolved and approved before release
• Recommend or approve release of API and Finished Drug Product for commercial or clinical use in alignment with the Qualified Person (QP) or Responsible Person (RP) where applicable
• Maintain product disposition documentation within the electronic Quality Management System (eQMS)

3. Deviation and Investigation Management

• Lead or review deviations, out-of-specification (OOS), and non-conformance investigations
• Ensure thorough root cause analysis and implementation of effective CAPAs
• Evaluate potential product impact and support decision-making on product disposition

4. Change Control and Continuous Improvement

• Review and approve manufacturing-related change controls to ensure risk assessments and validation requirements are appropriately addressed
• Identify opportunities for process and system improvement through trend analysis and quality metrics
• Support implementation of Quality Risk Management principles in daily operations

5. Cross-Functional Collaboration

• Collaborate with Manufacturing, QC, Supply Chain, Technical Operations, and Regulatory Affairs teams to ensure timely and compliant manufacturing operations
• Provide quality input during production planning, tech transfers, process validation, and process performance qualification (PPQ)
• Participat