Sr. Manager, Quality Systems Management

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

Eidos Therapeutics, an affiliate within BridgeBio Pharma, is a commercial-stage biopharmaceutical company focused on Transthyretin Amyloid Cardiomyopathy (ATTR-CM).

What You'll Do

The Sr. Manager, Quality Systems Management will report to the Vice President of Quality, CMC tasked with a wide range of responsibilities that ensure the smooth functioning of quality processes within an organization. This position will be responsible for overseeing the development, implementation, and continuous improvement of the quality management systems (QMS) to ensure compliance with GxP regulatory standards and company policies.  This position will also be responsible for overseeing the end-to-end compilation of Annual Product Quality Reviews (APQRs) and Quality Metrics for commercial marketed products. The role involves accurately and thoroughly collecting, analyzing, and summarizing product review data in a timely manner. The position will ensure compliance with the current regulated standards and internal procedures. This position will require strong cross-functional collaboration with internal stakeholders and external parties. 

Responsibilities

• Lead the creation, maintenance, and continuous improvement of the QMS
• Oversee the preparation and compilation of APQR reports, leading and managing the APQR process
• Define and generate quality metrics and Key Process Indicators (KPI) for Quality Management Reviews (QMRs), etc.
• Analyze and present quality data to identify trends, risks, and opportunities for improvement 
• Lead process improvement initiatives and implement corrective and preventive actions (CAPAs)
• Collaborate with internal and external key stakeholders for the compilation of quality metrics, APQR, etc.
• Ensure timely compilation of APQR and approval of necessary reports
• Escalate to management of potential trends, product quality, and regulatory compliance issues
• Participate in audits and regulatory inspections
• Ensure all activities comply with current GxP regulatory standards and internal procedures
• Establish work priorities to meet targets and timelines, and effectively manage competing priorities with minimal escalations
• Assist in the preparation, review, and revision of Standard Operating Procedures (SOPs) as required
• Other duties as assigned

Where You'll Work

This is a hybrid role and requires in-office collaboration as needed, in our San Francisco, CA office.

Who You Are

• Bachelor’s degree or equivalent in pharmacy, science, mathematics, or engineering required
• A minimum of 10+ years of experience working in a Biotech or Pharmaceutical FDA regulated industry in QA or a related field, or an equivalent combination of education, training, and/or experience from which comparable knowledge, skills, and abilities have been attained
• Knowledge of Lean Six Sigma Methodologies or equivalent is preferred
• Excellent analytical, problem-solving, and project management skills with keen attention to detail
• 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

Rewarding Those Who Make the Mission Possible

We have high expectations for our team members. We make sure those working hard for patients are rewarded and cared for in return. 

Financial Benefits:

• Market leading compensation 
• 401K with 100% employer match on first 3% & 50% on the next 2%
• Employee stock purchase program
• Pre-tax commuter benefits